Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01830543
Registration number
NCT01830543
Ethics application status
Date submitted
19/03/2013
Date registered
12/04/2013
Date last updated
19/09/2017
Titles & IDs
Public title
A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention
Query!
Scientific title
An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention
Query!
Secondary ID [1]
0
0
RIVAROXAFL3003
Query!
Secondary ID [2]
0
0
CR100758
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PIONEER AF-PCI
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
0
0
Query!
Percutaneous Coronary Intervention
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - rivaroxaban 2.5 mg
Treatment: Drugs - rivaroxaban 15 mg
Treatment: Drugs - rivaroxaban 10 mg
Treatment: Drugs - aspirin (ASA)
Treatment: Drugs - vitamin K antagonist (VKA)
Treatment: Drugs - clopidogrel
Treatment: Drugs - prasugrel
Treatment: Drugs - ticagrelor
Experimental: rivaroxaban 2.5 mg twice daily - rivaroxaban 2.5 mg tablet twice daily plus low-dose aspirin (ASA) 75 to 100 mg once daily and clopidogrel 75 mg tablet once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) followed by rivaroxaban 15 mg tablet (or 10 mg for subjects with moderate renal impairment) once daily plus low-dose ASA for 12 months
Experimental: vitamin K antagonist (VKA) - dose-adjusted vitamin K antagonist (VKA) once daily (target International Normalized Ratio (INR) 2.0 to 3.0) plus low-dose ASA, 75 to 100 mg per day, and clopidogrel 75 mg once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) followed by dose-adjusted VKA once daily (target INR 2.0 to 3.0 or 2.0 to 2.5 at the investigator discretion) plus low-dose ASA for 12 months
Experimental: rivaroxaban 15 mg once daily - rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) for 12 months
Treatment: Drugs: rivaroxaban 2.5 mg
One 2.5 mg tablet twice daily for up to twelve months
Treatment: Drugs: rivaroxaban 15 mg
One 15 mg tablet once daily for up to twelve months
Treatment: Drugs: rivaroxaban 10 mg
One 10 mg tablet once daily for up to twelve months
Treatment: Drugs: aspirin (ASA)
Low-dose aspirin tablet once daily for twelve months
Treatment: Drugs: vitamin K antagonist (VKA)
Dose-adjusted VKA tablet (target International Normalized Ratio (INR) 2.0 to 3.0) once daily for twelve months
Treatment: Drugs: clopidogrel
One 75 mg tablet once daily for up to twelve months
Treatment: Drugs: prasugrel
One 10 mg tablet once daily for up to twelve months
Treatment: Drugs: ticagrelor
One 90 mg tablet twice daily for up to twelve months
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Clinically Significant Bleeding
Query!
Assessment method [1]
0
0
Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.
Query!
Timepoint [1]
0
0
Up to Month 12
Query!
Secondary outcome [1]
0
0
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
Query!
Assessment method [1]
0
0
TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, Clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of >= 5 g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent).
Query!
Timepoint [1]
0
0
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Query!
Secondary outcome [2]
0
0
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding
Query!
Assessment method [2]
0
0
TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to <5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent).
Query!
Timepoint [2]
0
0
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Query!
Secondary outcome [3]
0
0
Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)
Query!
Assessment method [3]
0
0
A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.
Query!
Timepoint [3]
0
0
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Query!
Secondary outcome [4]
0
0
Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)
Query!
Assessment method [4]
0
0
Percentage of participants who experienced adverse cardiovascular events (cardiovascular death, myocardial Infarction (MI) and stroke) collectively, were assessed.
Query!
Timepoint [4]
0
0
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Query!
Secondary outcome [5]
0
0
Percentage of Participants With Cardiovascular Death
Query!
Assessment method [5]
0
0
The percentage of participants with the first occurrence of cardiovascular death were evaluated.
Query!
Timepoint [5]
0
0
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Query!
Secondary outcome [6]
0
0
Percentage of Participants With Myocardial Infarction
Query!
Assessment method [6]
0
0
The percentage of participants with the first occurrence of Myocardial Infarction were evaluated.
Query!
Timepoint [6]
0
0
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Query!
Secondary outcome [7]
0
0
Percentage of Participants With Stroke
Query!
Assessment method [7]
0
0
The percentage of participants with the first occurrence of Stroke were evaluated.
Query!
Timepoint [7]
0
0
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Query!
Secondary outcome [8]
0
0
Percentage of Participants With Stent Thrombosis
Query!
Assessment method [8]
0
0
The percentage of participants with the first occurrence of stent thrombosis were evaluated.
Query!
Timepoint [8]
0
0
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Query!
Eligibility
Key inclusion criteria
- Have a documented medical history of paroxysmal, persistent, or permanent non-valvular
atrial fibrillation (AF)
- Have undergone percutaneous coronary intervention (PCI) procedure (with stent
placement) for primary atherosclerotic disease
- Must have an international normalized ratio (INR) of 2.5 or below to be randomized
- Women must be postmenopausal before entry or practicing a highly effective method of
birth control when heterosexually active
- Be willing and able to adhere to the prohibitions and restrictions specified in the
study protocol
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Have any condition that contraindicates anticoagulant or antiplatelet therapy or would
have an unacceptable risk of bleeding, such as, but not limited to: platelet count
<90,000/microliter at screening, history of intracranial hemorrhage, 12 month history
of clinically significant gastrointestinal bleeding, non-VKA induced elevated
prothrombin time (PT) at screening
- Have anemia of unknown cause with a hemoglobin level <10 g/dL (<6.21 mmol/L)
- Have a history of stroke or Transient Ischemic Attack (TIA)
- Have a calculated Creatinine Clearance (CrCl) <30 mL/min at screening
- Have known significant liver disease or liver function test (LFT) abnormalities
- Have any severe condition that would limit life expectancy to less than 12 months
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
10/05/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
28/07/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
2124
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Chermside N/A
Query!
Recruitment hospital [2]
0
0
- Epping
Query!
Recruitment hospital [3]
0
0
- Hobart
Query!
Recruitment hospital [4]
0
0
- Kogarah
Query!
Recruitment hospital [5]
0
0
- Liverpool
Query!
Recruitment hospital [6]
0
0
- New Lambton
Query!
Recruitment hospital [7]
0
0
- Wollongong
Query!
Recruitment postcode(s) [1]
0
0
- Chermside N/A
Query!
Recruitment postcode(s) [2]
0
0
- Epping
Query!
Recruitment postcode(s) [3]
0
0
- Hobart
Query!
Recruitment postcode(s) [4]
0
0
- Kogarah
Query!
Recruitment postcode(s) [5]
0
0
- Liverpool
Query!
Recruitment postcode(s) [6]
0
0
- New Lambton
Query!
Recruitment postcode(s) [7]
0
0
- Wollongong
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Idaho
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maine
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Maryland
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Missouri
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Montana
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Nevada
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New Jersey
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Mexico
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New York
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
North Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Oklahoma
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Oregon
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Pennsylvania
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
South Carolina
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
South Dakota
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Tennessee
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Texas
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Utah
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Virginia
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Washington
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Wisconsin
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Bahia Blanca
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Buenos Aires
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
C.a.b.a.
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Cordoba
Query!
Country [37]
0
0
Argentina
Query!
State/province [37]
0
0
Corrientes
Query!
Country [38]
0
0
Argentina
Query!
State/province [38]
0
0
La Plata
Query!
Country [39]
0
0
Argentina
Query!
State/province [39]
0
0
Resistencia
Query!
Country [40]
0
0
Argentina
Query!
State/province [40]
0
0
Rosario
Query!
Country [41]
0
0
Argentina
Query!
State/province [41]
0
0
Santa Fe
Query!
Country [42]
0
0
Argentina
Query!
State/province [42]
0
0
Vicente Lopez
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
Aalst
Query!
Country [44]
0
0
Belgium
Query!
State/province [44]
0
0
Bonheiden
Query!
Country [45]
0
0
Belgium
Query!
State/province [45]
0
0
Brasschaat
Query!
Country [46]
0
0
Belgium
Query!
State/province [46]
0
0
Brugge
Query!
Country [47]
0
0
Belgium
Query!
State/province [47]
0
0
Bruxelles
Query!
Country [48]
0
0
Belgium
Query!
State/province [48]
0
0
Genk
Query!
Country [49]
0
0
Belgium
Query!
State/province [49]
0
0
Gent
Query!
Country [50]
0
0
Belgium
Query!
State/province [50]
0
0
Liège
Query!
Country [51]
0
0
Belgium
Query!
State/province [51]
0
0
Mechelen
Query!
Country [52]
0
0
Belgium
Query!
State/province [52]
0
0
Mol
Query!
Country [53]
0
0
Belgium
Query!
State/province [53]
0
0
Roeselare
Query!
Country [54]
0
0
Belgium
Query!
State/province [54]
0
0
Turnhout
Query!
Country [55]
0
0
Brazil
Query!
State/province [55]
0
0
Belo Horizonte
Query!
Country [56]
0
0
Brazil
Query!
State/province [56]
0
0
Blumenau
Query!
Country [57]
0
0
Brazil
Query!
State/province [57]
0
0
Brasilia
Query!
Country [58]
0
0
Brazil
Query!
State/province [58]
0
0
Campina Grande Do Sul
Query!
Country [59]
0
0
Brazil
Query!
State/province [59]
0
0
Campinas
Query!
Country [60]
0
0
Brazil
Query!
State/province [60]
0
0
Curitiba
Query!
Country [61]
0
0
Brazil
Query!
State/province [61]
0
0
Marilia
Query!
Country [62]
0
0
Brazil
Query!
State/province [62]
0
0
Passo Fundo
Query!
Country [63]
0
0
Brazil
Query!
State/province [63]
0
0
Porto Alegre
Query!
Country [64]
0
0
Brazil
Query!
State/province [64]
0
0
Recife
Query!
Country [65]
0
0
Brazil
Query!
State/province [65]
0
0
Sao Paulo
Query!
Country [66]
0
0
Brazil
Query!
State/province [66]
0
0
São José Do Rio Preto
Query!
Country [67]
0
0
Brazil
Query!
State/province [67]
0
0
São Paulo
Query!
Country [68]
0
0
Brazil
Query!
State/province [68]
0
0
Uberlandia
Query!
Country [69]
0
0
Brazil
Query!
State/province [69]
0
0
Votuporanga
Query!
Country [70]
0
0
Bulgaria
Query!
State/province [70]
0
0
Blagoevgrad
Query!
Country [71]
0
0
Bulgaria
Query!
State/province [71]
0
0
Burgas
Query!
Country [72]
0
0
Bulgaria
Query!
State/province [72]
0
0
Pazardjik
Query!
Country [73]
0
0
Bulgaria
Query!
State/province [73]
0
0
Pleven
Query!
Country [74]
0
0
Bulgaria
Query!
State/province [74]
0
0
Plovdiv
Query!
Country [75]
0
0
Bulgaria
Query!
State/province [75]
0
0
Sofia
Query!
Country [76]
0
0
Bulgaria
Query!
State/province [76]
0
0
Varna
Query!
Country [77]
0
0
Bulgaria
Query!
State/province [77]
0
0
Veliko Tarnovo
Query!
Country [78]
0
0
Canada
Query!
State/province [78]
0
0
Alberta
Query!
Country [79]
0
0
Canada
Query!
State/province [79]
0
0
British Columbia
Query!
Country [80]
0
0
Canada
Query!
State/province [80]
0
0
Newfoundland and Labrador
Query!
Country [81]
0
0
Canada
Query!
State/province [81]
0
0
Ontario
Query!
Country [82]
0
0
Canada
Query!
State/province [82]
0
0
Quebec
Query!
Country [83]
0
0
Canada
Query!
State/province [83]
0
0
Chicoutimi
Query!
Country [84]
0
0
Canada
Query!
State/province [84]
0
0
Saint John
Query!
Country [85]
0
0
Chile
Query!
State/province [85]
0
0
Alto
Query!
Country [86]
0
0
Chile
Query!
State/province [86]
0
0
Concepcion
Query!
Country [87]
0
0
Chile
Query!
State/province [87]
0
0
Punta Arenas
Query!
Country [88]
0
0
Chile
Query!
State/province [88]
0
0
Santiago
Query!
Country [89]
0
0
Chile
Query!
State/province [89]
0
0
Temuco
Query!
Country [90]
0
0
Czechia
Query!
State/province [90]
0
0
Brno 2
Query!
Country [91]
0
0
Czechia
Query!
State/province [91]
0
0
Brno
Query!
Country [92]
0
0
Czechia
Query!
State/province [92]
0
0
Hradec Kralove
Query!
Country [93]
0
0
Czechia
Query!
State/province [93]
0
0
Jablonec Na Nisou
Query!
Country [94]
0
0
Czechia
Query!
State/province [94]
0
0
Karlovy Vary
Query!
Country [95]
0
0
Czechia
Query!
State/province [95]
0
0
Kladno
Query!
Country [96]
0
0
Czechia
Query!
State/province [96]
0
0
Litomysl
Query!
Country [97]
0
0
Czechia
Query!
State/province [97]
0
0
Olomouc
Query!
Country [98]
0
0
Czechia
Query!
State/province [98]
0
0
Plzen
Query!
Country [99]
0
0
Czechia
Query!
State/province [99]
0
0
Praha 10 N/A
Query!
Country [100]
0
0
Czechia
Query!
State/province [100]
0
0
Praha 2
Query!
Country [101]
0
0
Czechia
Query!
State/province [101]
0
0
Praha
Query!
Country [102]
0
0
Czechia
Query!
State/province [102]
0
0
Slany
Query!
Country [103]
0
0
Czechia
Query!
State/province [103]
0
0
Uherske Hradiste
Query!
Country [104]
0
0
Denmark
Query!
State/province [104]
0
0
Aalborg
Query!
Country [105]
0
0
Denmark
Query!
State/province [105]
0
0
Copenhagen
Query!
Country [106]
0
0
Denmark
Query!
State/province [106]
0
0
Esbjerg
Query!
Country [107]
0
0
Denmark
Query!
State/province [107]
0
0
Herlev
Query!
Country [108]
0
0
Denmark
Query!
State/province [108]
0
0
Herning
Query!
Country [109]
0
0
Denmark
Query!
State/province [109]
0
0
Hvidovre
Query!
Country [110]
0
0
Denmark
Query!
State/province [110]
0
0
Koege
Query!
Country [111]
0
0
Denmark
Query!
State/province [111]
0
0
Naestved
Query!
Country [112]
0
0
Denmark
Query!
State/province [112]
0
0
Odense
Query!
Country [113]
0
0
Denmark
Query!
State/province [113]
0
0
Roskilde
Query!
Country [114]
0
0
Denmark
Query!
State/province [114]
0
0
Svendborg N/A
Query!
Country [115]
0
0
Denmark
Query!
State/province [115]
0
0
Vejle
Query!
Country [116]
0
0
France
Query!
State/province [116]
0
0
Besancon Cedex Franche-Comté
Query!
Country [117]
0
0
France
Query!
State/province [117]
0
0
Caen Cedex 9
Query!
Country [118]
0
0
France
Query!
State/province [118]
0
0
Centres
Query!
Country [119]
0
0
France
Query!
State/province [119]
0
0
Chartres
Query!
Country [120]
0
0
France
Query!
State/province [120]
0
0
Lille
Query!
Country [121]
0
0
France
Query!
State/province [121]
0
0
Limoges Cedex
Query!
Country [122]
0
0
France
Query!
State/province [122]
0
0
Marseille Cedex 05
Query!
Country [123]
0
0
France
Query!
State/province [123]
0
0
Montfermeil
Query!
Country [124]
0
0
France
Query!
State/province [124]
0
0
Nantes Cedex 1
Query!
Country [125]
0
0
France
Query!
State/province [125]
0
0
Nimes
Query!
Country [126]
0
0
France
Query!
State/province [126]
0
0
Paris 75
Query!
Country [127]
0
0
France
Query!
State/province [127]
0
0
Paris
Query!
Country [128]
0
0
France
Query!
State/province [128]
0
0
Pau
Query!
Country [129]
0
0
France
Query!
State/province [129]
0
0
Pessac
Query!
Country [130]
0
0
France
Query!
State/province [130]
0
0
Poitiers
Query!
Country [131]
0
0
France
Query!
State/province [131]
0
0
Toulouse
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
Bad Friedrichshall
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Bad Nauheim
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Berlin
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Dresden
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Esslingen
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Frankfurt Am Main
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Freiburg
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
Greifswald
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Göttingen
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Hamburg
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Heidelberg
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Köln
Query!
Country [144]
0
0
Germany
Query!
State/province [144]
0
0
Limburg
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Mannheim
Query!
Country [146]
0
0
Germany
Query!
State/province [146]
0
0
Ulm
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Witten
Query!
Country [148]
0
0
Korea, Republic of
Query!
State/province [148]
0
0
Busan
Query!
Country [149]
0
0
Korea, Republic of
Query!
State/province [149]
0
0
Daejeon
Query!
Country [150]
0
0
Korea, Republic of
Query!
State/province [150]
0
0
Gyeonggi-Do
Query!
Country [151]
0
0
Korea, Republic of
Query!
State/province [151]
0
0
Incheon
Query!
Country [152]
0
0
Korea, Republic of
Query!
State/province [152]
0
0
Seongnam
Query!
Country [153]
0
0
Korea, Republic of
Query!
State/province [153]
0
0
Seoul
Query!
Country [154]
0
0
Korea, Republic of
Query!
State/province [154]
0
0
Suwon
Query!
Country [155]
0
0
Korea, Republic of
Query!
State/province [155]
0
0
Uijeongbu
Query!
Country [156]
0
0
Korea, Republic of
Query!
State/province [156]
0
0
Wonju
Query!
Country [157]
0
0
Malaysia
Query!
State/province [157]
0
0
Georgetown
Query!
Country [158]
0
0
Malaysia
Query!
State/province [158]
0
0
Johor Bahru
Query!
Country [159]
0
0
Malaysia
Query!
State/province [159]
0
0
Kajang
Query!
Country [160]
0
0
Malaysia
Query!
State/province [160]
0
0
Kuala Lumpur
Query!
Country [161]
0
0
Mexico
Query!
State/province [161]
0
0
Aguascalientes
Query!
Country [162]
0
0
Mexico
Query!
State/province [162]
0
0
Guadalajara
Query!
Country [163]
0
0
Mexico
Query!
State/province [163]
0
0
Leon
Query!
Country [164]
0
0
Mexico
Query!
State/province [164]
0
0
Mexico
Query!
Country [165]
0
0
Mexico
Query!
State/province [165]
0
0
Pachuca
Query!
Country [166]
0
0
Mexico
Query!
State/province [166]
0
0
Puebla
Query!
Country [167]
0
0
Mexico
Query!
State/province [167]
0
0
Queretaro
Query!
Country [168]
0
0
Mexico
Query!
State/province [168]
0
0
Villahermosa
Query!
Country [169]
0
0
Mexico
Query!
State/province [169]
0
0
Zapopan
Query!
Country [170]
0
0
Netherlands
Query!
State/province [170]
0
0
Alkmaar
Query!
Country [171]
0
0
Netherlands
Query!
State/province [171]
0
0
Amsterdam Zuidoost
Query!
Country [172]
0
0
Netherlands
Query!
State/province [172]
0
0
Amsterdam
Query!
Country [173]
0
0
Netherlands
Query!
State/province [173]
0
0
Breda
Query!
Country [174]
0
0
Netherlands
Query!
State/province [174]
0
0
Delft
Query!
Country [175]
0
0
Netherlands
Query!
State/province [175]
0
0
Den Bosch
Query!
Country [176]
0
0
Netherlands
Query!
State/province [176]
0
0
Gorinchem
Query!
Country [177]
0
0
Netherlands
Query!
State/province [177]
0
0
Leiden
Query!
Country [178]
0
0
Netherlands
Query!
State/province [178]
0
0
Maastricht
Query!
Country [179]
0
0
Netherlands
Query!
State/province [179]
0
0
Nieuwegein
Query!
Country [180]
0
0
Netherlands
Query!
State/province [180]
0
0
Sneek
Query!
Country [181]
0
0
Netherlands
Query!
State/province [181]
0
0
Uden
Query!
Country [182]
0
0
Poland
Query!
State/province [182]
0
0
Bedzin
Query!
Country [183]
0
0
Poland
Query!
State/province [183]
0
0
Bielsko-Biala
Query!
Country [184]
0
0
Poland
Query!
State/province [184]
0
0
Chrzanow
Query!
Country [185]
0
0
Poland
Query!
State/province [185]
0
0
Gdynia
Query!
Country [186]
0
0
Poland
Query!
State/province [186]
0
0
Grodzisk Mazowiecki
Query!
Country [187]
0
0
Poland
Query!
State/province [187]
0
0
Katowice
Query!
Country [188]
0
0
Poland
Query!
State/province [188]
0
0
Krakow
Query!
Country [189]
0
0
Poland
Query!
State/province [189]
0
0
Lodz
Query!
Country [190]
0
0
Poland
Query!
State/province [190]
0
0
Mielec
Query!
Country [191]
0
0
Poland
Query!
State/province [191]
0
0
Nowy Targ
Query!
Country [192]
0
0
Poland
Query!
State/province [192]
0
0
Ostrowiec Swietokrzyski
Query!
Country [193]
0
0
Poland
Query!
State/province [193]
0
0
Oswiecim
Query!
Country [194]
0
0
Poland
Query!
State/province [194]
0
0
Plock
Query!
Country [195]
0
0
Poland
Query!
State/province [195]
0
0
Rzeszow Poland
Query!
Country [196]
0
0
Poland
Query!
State/province [196]
0
0
Starachowice
Query!
Country [197]
0
0
Poland
Query!
State/province [197]
0
0
Starogard Gdanski
Query!
Country [198]
0
0
Poland
Query!
State/province [198]
0
0
Szczecin
Query!
Country [199]
0
0
Poland
Query!
State/province [199]
0
0
Torun
Query!
Country [200]
0
0
Poland
Query!
State/province [200]
0
0
Tychy
Query!
Country [201]
0
0
Poland
Query!
State/province [201]
0
0
Ustron
Query!
Country [202]
0
0
Poland
Query!
State/province [202]
0
0
Warszawa
Query!
Country [203]
0
0
Poland
Query!
State/province [203]
0
0
Zamosc
Query!
Country [204]
0
0
Romania
Query!
State/province [204]
0
0
Bucharest
Query!
Country [205]
0
0
Romania
Query!
State/province [205]
0
0
Bucuresti
Query!
Country [206]
0
0
Romania
Query!
State/province [206]
0
0
Cluj Napoca
Query!
Country [207]
0
0
Romania
Query!
State/province [207]
0
0
Targu-Mures
Query!
Country [208]
0
0
Romania
Query!
State/province [208]
0
0
Tg Mures
Query!
Country [209]
0
0
Russian Federation
Query!
State/province [209]
0
0
Arkhangelsk
Query!
Country [210]
0
0
Russian Federation
Query!
State/province [210]
0
0
Barnaul
Query!
Country [211]
0
0
Russian Federation
Query!
State/province [211]
0
0
Chita
Query!
Country [212]
0
0
Russian Federation
Query!
State/province [212]
0
0
Ekaterinburg
Query!
Country [213]
0
0
Russian Federation
Query!
State/province [213]
0
0
Kemerovo
Query!
Country [214]
0
0
Russian Federation
Query!
State/province [214]
0
0
Krasnodar
Query!
Country [215]
0
0
Russian Federation
Query!
State/province [215]
0
0
Krasnoyarsk
Query!
Country [216]
0
0
Russian Federation
Query!
State/province [216]
0
0
Moscow
Query!
Country [217]
0
0
Russian Federation
Query!
State/province [217]
0
0
Nizhny Novgorod
Query!
Country [218]
0
0
Russian Federation
Query!
State/province [218]
0
0
Perm
Query!
Country [219]
0
0
Russian Federation
Query!
State/province [219]
0
0
Rostov On Don
Query!
Country [220]
0
0
Russian Federation
Query!
State/province [220]
0
0
Samara
Query!
Country [221]
0
0
Russian Federation
Query!
State/province [221]
0
0
Saratov
Query!
Country [222]
0
0
Russian Federation
Query!
State/province [222]
0
0
St. Petersburg
Query!
Country [223]
0
0
Russian Federation
Query!
State/province [223]
0
0
Syktyvkar
Query!
Country [224]
0
0
Russian Federation
Query!
State/province [224]
0
0
Tumen
Query!
Country [225]
0
0
Russian Federation
Query!
State/province [225]
0
0
Tyumen
Query!
Country [226]
0
0
South Africa
Query!
State/province [226]
0
0
Cape Town
Query!
Country [227]
0
0
South Africa
Query!
State/province [227]
0
0
Centurion
Query!
Country [228]
0
0
South Africa
Query!
State/province [228]
0
0
Linksfield West, Johannesburg
Query!
Country [229]
0
0
South Africa
Query!
State/province [229]
0
0
Somerset West
Query!
Country [230]
0
0
Sweden
Query!
State/province [230]
0
0
Falun
Query!
Country [231]
0
0
Sweden
Query!
State/province [231]
0
0
Göteborg
Query!
Country [232]
0
0
Sweden
Query!
State/province [232]
0
0
Jönköping
Query!
Country [233]
0
0
Sweden
Query!
State/province [233]
0
0
Lund
Query!
Country [234]
0
0
Sweden
Query!
State/province [234]
0
0
Malmö
Query!
Country [235]
0
0
Sweden
Query!
State/province [235]
0
0
Stockholm N/A
Query!
Country [236]
0
0
Sweden
Query!
State/province [236]
0
0
Stockholm
Query!
Country [237]
0
0
Sweden
Query!
State/province [237]
0
0
Umeå
Query!
Country [238]
0
0
Sweden
Query!
State/province [238]
0
0
Örebro
Query!
Country [239]
0
0
Taiwan
Query!
State/province [239]
0
0
Kaohsiung
Query!
Country [240]
0
0
Taiwan
Query!
State/province [240]
0
0
Taichung
Query!
Country [241]
0
0
Taiwan
Query!
State/province [241]
0
0
Tainan
Query!
Country [242]
0
0
Taiwan
Query!
State/province [242]
0
0
Taipei
Query!
Country [243]
0
0
Taiwan
Query!
State/province [243]
0
0
Taoyuan
Query!
Country [244]
0
0
Turkey
Query!
State/province [244]
0
0
Ankara
Query!
Country [245]
0
0
Turkey
Query!
State/province [245]
0
0
Antalya
Query!
Country [246]
0
0
Turkey
Query!
State/province [246]
0
0
Bursa
Query!
Country [247]
0
0
Turkey
Query!
State/province [247]
0
0
Gaziantep
Query!
Country [248]
0
0
Turkey
Query!
State/province [248]
0
0
Istanbul Nap
Query!
Country [249]
0
0
Turkey
Query!
State/province [249]
0
0
Istanbul
Query!
Country [250]
0
0
Turkey
Query!
State/province [250]
0
0
Izmir
Query!
Country [251]
0
0
Turkey
Query!
State/province [251]
0
0
Kayseri
Query!
Country [252]
0
0
Turkey
Query!
State/province [252]
0
0
Sivas
Query!
Country [253]
0
0
Ukraine
Query!
State/province [253]
0
0
Cherkassy
Query!
Country [254]
0
0
Ukraine
Query!
State/province [254]
0
0
Dnepropetrovsk
Query!
Country [255]
0
0
Ukraine
Query!
State/province [255]
0
0
Ivano-Frankivsk
Query!
Country [256]
0
0
Ukraine
Query!
State/province [256]
0
0
Kharkiv
Query!
Country [257]
0
0
Ukraine
Query!
State/province [257]
0
0
Kharkov
Query!
Country [258]
0
0
Ukraine
Query!
State/province [258]
0
0
Khemelnitskiy
Query!
Country [259]
0
0
Ukraine
Query!
State/province [259]
0
0
Kyiv
Query!
Country [260]
0
0
Ukraine
Query!
State/province [260]
0
0
Lviv
Query!
Country [261]
0
0
Ukraine
Query!
State/province [261]
0
0
Odessa
Query!
Country [262]
0
0
Ukraine
Query!
State/province [262]
0
0
Rivne
Query!
Country [263]
0
0
Ukraine
Query!
State/province [263]
0
0
Uzhgorod
Query!
Country [264]
0
0
Ukraine
Query!
State/province [264]
0
0
Zaporizhzhya
Query!
Country [265]
0
0
United Kingdom
Query!
State/province [265]
0
0
Bath
Query!
Country [266]
0
0
United Kingdom
Query!
State/province [266]
0
0
Birmingham
Query!
Country [267]
0
0
United Kingdom
Query!
State/province [267]
0
0
Blackburn
Query!
Country [268]
0
0
United Kingdom
Query!
State/province [268]
0
0
Bradford
Query!
Country [269]
0
0
United Kingdom
Query!
State/province [269]
0
0
Clydebank
Query!
Country [270]
0
0
United Kingdom
Query!
State/province [270]
0
0
Cottingham
Query!
Country [271]
0
0
United Kingdom
Query!
State/province [271]
0
0
Coventry
Query!
Country [272]
0
0
United Kingdom
Query!
State/province [272]
0
0
Dorchester
Query!
Country [273]
0
0
United Kingdom
Query!
State/province [273]
0
0
Dundee
Query!
Country [274]
0
0
United Kingdom
Query!
State/province [274]
0
0
Edinburgh
Query!
Country [275]
0
0
United Kingdom
Query!
State/province [275]
0
0
Exeter
Query!
Country [276]
0
0
United Kingdom
Query!
State/province [276]
0
0
Hampshire
Query!
Country [277]
0
0
United Kingdom
Query!
State/province [277]
0
0
Harrow
Query!
Country [278]
0
0
United Kingdom
Query!
State/province [278]
0
0
High Wycombe
Query!
Country [279]
0
0
United Kingdom
Query!
State/province [279]
0
0
London
Query!
Country [280]
0
0
United Kingdom
Query!
State/province [280]
0
0
Middlesbrough N/A
Query!
Country [281]
0
0
United Kingdom
Query!
State/province [281]
0
0
Norwich
Query!
Country [282]
0
0
United Kingdom
Query!
State/province [282]
0
0
Nottingham
Query!
Country [283]
0
0
United Kingdom
Query!
State/province [283]
0
0
Plymouth
Query!
Country [284]
0
0
United Kingdom
Query!
State/province [284]
0
0
Portsmouth
Query!
Country [285]
0
0
United Kingdom
Query!
State/province [285]
0
0
Torquay
Query!
Country [286]
0
0
United Kingdom
Query!
State/province [286]
0
0
Truro
Query!
Country [287]
0
0
United Kingdom
Query!
State/province [287]
0
0
Worcester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Janssen Scientific Affairs, LLC
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Bayer
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban
treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various
combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or
prasugrel or ticagrelor).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01830543
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen Scientific Affairs, LLC Clinical Trial
Query!
Address
0
0
Janssen Scientific Affairs, LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01830543
Download to PDF