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/NCT01813435
Registration number
NCT01813435
Ethics application status
Date submitted
12/02/2013
Date registered
19/03/2013
Date last updated
15/03/2022
Titles & IDs
Public title
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
Query!
Scientific title
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
Query!
Secondary ID [1]
0
0
ECRI-12-001, 02EU11
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease (CAD)
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Ticagrelor
Treatment: Drugs - Acetylsalicylic Acid
Treatment: Drugs - Clopidogrel
Experimental: Experimental treatment strategy - All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.
Dosage and frequency:
Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- = 100 mg qd)
Active Comparator: Reference treatment strategy - Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.
Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.
Dosage and frequency:
Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- = 100 mg qd) Clopidogrel: 75 mg qd
Treatment: Drugs: Ticagrelor
Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
Treatment: Drugs: Acetylsalicylic Acid
Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
Treatment: Drugs: Clopidogrel
Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.
Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)
Query!
Assessment method [1]
0
0
Number of Participants with a composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation.
Query!
Timepoint [1]
0
0
2 year
Query!
Secondary outcome [1]
0
0
Number of Participants With All-cause Mortality
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
2-year
Query!
Secondary outcome [2]
0
0
Number of Participants With Myocardial Infarction
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
2 year
Query!
Secondary outcome [3]
0
0
Number of Participants With New Q-wave Myocardial Infarction
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
2-year
Query!
Secondary outcome [4]
0
0
Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction
Query!
Assessment method [4]
0
0
shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded
Query!
Timepoint [4]
0
0
2-year
Query!
Secondary outcome [5]
0
0
Number of Participants With a Stroke
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
2 year
Query!
Secondary outcome [6]
0
0
Number of Participants With a Myocardial Revascularisation
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
2 year
Query!
Secondary outcome [7]
0
0
Number of Participants With a Definite Stent Thrombosis
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
2 year
Query!
Secondary outcome [8]
0
0
Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding
Query!
Assessment method [8]
0
0
BARC definition. We only considered BARC 3 or 5 for this secondary safety endpoint.
Type 3: Clinical, laboratory, and/or imaging evidence of bleeding with:
Type 3a:
Overt bleeding + Hb drop of 3 to < 5 g/dL (provided Hb drop is related to bleed)
Any transfusion with overt bleeding
Type 3b:
Overt bleeding + Hb drop =5 g/dL (provided Hb drop is related to bleed)
Cardiac tamponade
Bleeding requiring surgical intervention (excluding dental/nasal/skin/haemorrhoid)
Bleeding requiring intravenous vasoactive agents
Type 3c:
Intracranial haemorrhage (does not include microbleeds or haemorrhagic transformation, does include intraspinal)
Subcategories confirmed by autopsy or imaging or lumbar puncture
Intraocular bleed compromising vision. Type 5: Fatal bleeding
Type 5a:
• Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious
Type 5b:
Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation
Query!
Timepoint [8]
0
0
2 year
Query!
Eligibility
Key inclusion criteria
-"All comer" patients
1. Age =18 years;
2. Presence of one or more coronary artery stenoses of 50% or more in a native coronary
artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent
implantation. The vessel should have a reference vessel diameter of at least 2.25 mm
(no limitation on the number of treated lesions, vessels, or lesion length);
3. Able to provide informed consent and willing to participate in 2 year follow- up
period.
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
1. Known intolerance to aspirin, P2Y12 inhibitors, bivalirudin, stainless steel or
biolimus;
2. Known intake of a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin,
nefazodone, ritonavir, and atazanavir), as co-administration may lead to a substantial
increase in exposure to ticagrelor;
3. Known moderate to severe hepatic impairment (alanine-aminotransferase = 3 x ULN);
4. Planned surgery, including coronary artery bypass graft (CABG) as a staged procedure
(hybrid) within 12 months of the index procedure, unless dual antiplatelet therapy is
maintained throughout the peri-surgical period;
5. Need for chronic oral anti-coagulation therapy;
6. Active major bleeding or major surgery within the last 30 days;
7. Known history of intracranial haemorrhagic stroke or intra-cranial aneurysm;
8. Known stroke (any type) within the last 30 days;
9. Known pregnancy at time of randomisation;
10. Female who is breastfeeding at time of randomisation;
11. Currently participating in another trial and not yet at its primary endpoint.
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
1/07/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
26/04/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
15991
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research centre Brisbane, 6101 - Brisbane
Query!
Recruitment hospital [2]
0
0
Research centre Melbourne, 6104 - Melbourne
Query!
Recruitment hospital [3]
0
0
Research centre Melbourne, 6105 - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
- Brisbane
Query!
Recruitment postcode(s) [2]
0
0
- Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
Austria
Query!
State/province [1]
0
0
Graz
Query!
Country [2]
0
0
Austria
Query!
State/province [2]
0
0
Innsbruck
Query!
Country [3]
0
0
Austria
Query!
State/province [3]
0
0
Linz
Query!
Country [4]
0
0
Austria
Query!
State/province [4]
0
0
Vienna
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Aalst
Query!
Country [6]
0
0
Belgium
Query!
State/province [6]
0
0
Bonheiden
Query!
Country [7]
0
0
Belgium
Query!
State/province [7]
0
0
Charleroi
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
Genk
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Hasselt
Query!
Country [10]
0
0
Brazil
Query!
State/province [10]
0
0
Rio de Janeiro
Query!
Country [11]
0
0
Brazil
Query!
State/province [11]
0
0
Sao Paulo
Query!
Country [12]
0
0
Brazil
Query!
State/province [12]
0
0
Uberlândia
Query!
Country [13]
0
0
Bulgaria
Query!
State/province [13]
0
0
Burgas
Query!
Country [14]
0
0
Bulgaria
Query!
State/province [14]
0
0
Plovdiv
Query!
Country [15]
0
0
Bulgaria
Query!
State/province [15]
0
0
Sofia
Query!
Country [16]
0
0
Bulgaria
Query!
State/province [16]
0
0
Varna
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Newmarket
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Quebec
Query!
Country [19]
0
0
Denmark
Query!
State/province [19]
0
0
Copenhagen
Query!
Country [20]
0
0
Denmark
Query!
State/province [20]
0
0
Roskilde
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Aix en Provence
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Caen
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Clermont-Ferrand
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Dijon
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Grenoble Cedex
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Lyon
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Nancy
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Paris
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Rouen
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Saint Etienne
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Toulouse
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Bad Krozingen
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Bad Nauheim
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Berlin
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Bonn
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Dresden
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Essen
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Fulda
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Giessen
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Göttingen
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Landshut
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Lubeck
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Mainz
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Mannheim
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Mönchengladbach
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Neuss
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Tubingen
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Villingen - Schwenningen
Query!
Country [49]
0
0
Hungary
Query!
State/province [49]
0
0
Balatonfüred
Query!
Country [50]
0
0
Hungary
Query!
State/province [50]
0
0
Budapest
Query!
Country [51]
0
0
Hungary
Query!
State/province [51]
0
0
Debrecen
Query!
Country [52]
0
0
Hungary
Query!
State/province [52]
0
0
Gyula
Query!
Country [53]
0
0
Hungary
Query!
State/province [53]
0
0
Nyíregyháza
Query!
Country [54]
0
0
Hungary
Query!
State/province [54]
0
0
Pécs
Query!
Country [55]
0
0
Hungary
Query!
State/province [55]
0
0
Szeged
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Arezzo
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Brescia
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Ferrara
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Milano
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Pavia
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
Terni
Query!
Country [62]
0
0
Netherlands
Query!
State/province [62]
0
0
Alkmaar
Query!
Country [63]
0
0
Netherlands
Query!
State/province [63]
0
0
Amsterdam
Query!
Country [64]
0
0
Netherlands
Query!
State/province [64]
0
0
Groningen
Query!
Country [65]
0
0
Netherlands
Query!
State/province [65]
0
0
Leeuwarden
Query!
Country [66]
0
0
Netherlands
Query!
State/province [66]
0
0
Nieuwegein
Query!
Country [67]
0
0
Netherlands
Query!
State/province [67]
0
0
Nijmegen
Query!
Country [68]
0
0
Netherlands
Query!
State/province [68]
0
0
Rotterdam
Query!
Country [69]
0
0
Netherlands
Query!
State/province [69]
0
0
Tilburg
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Chrzanow
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Dabrowa Gornicza
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Kedzierzyn-Kozle
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Krakov
Query!
Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Mielec
Query!
Country [75]
0
0
Poland
Query!
State/province [75]
0
0
Nysa
Query!
Country [76]
0
0
Poland
Query!
State/province [76]
0
0
Ustron
Query!
Country [77]
0
0
Portugal
Query!
State/province [77]
0
0
Gaia
Query!
Country [78]
0
0
Portugal
Query!
State/province [78]
0
0
Lisbon
Query!
Country [79]
0
0
Singapore
Query!
State/province [79]
0
0
Singapore
Query!
Country [80]
0
0
Spain
Query!
State/province [80]
0
0
Barcelona
Query!
Country [81]
0
0
Spain
Query!
State/province [81]
0
0
Huelva
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Madrid
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Vigo
Query!
Country [84]
0
0
Switzerland
Query!
State/province [84]
0
0
Bern
Query!
Country [85]
0
0
Switzerland
Query!
State/province [85]
0
0
Geneva
Query!
Country [86]
0
0
Switzerland
Query!
State/province [86]
0
0
Lausanne
Query!
Country [87]
0
0
Switzerland
Query!
State/province [87]
0
0
Liestal
Query!
Country [88]
0
0
Switzerland
Query!
State/province [88]
0
0
Lugano
Query!
Country [89]
0
0
United Kingdom
Query!
State/province [89]
0
0
Belfast
Query!
Country [90]
0
0
United Kingdom
Query!
State/province [90]
0
0
Blackburn
Query!
Country [91]
0
0
United Kingdom
Query!
State/province [91]
0
0
Blackpool
Query!
Country [92]
0
0
United Kingdom
Query!
State/province [92]
0
0
Bournemouth
Query!
Country [93]
0
0
United Kingdom
Query!
State/province [93]
0
0
Brighton
Query!
Country [94]
0
0
United Kingdom
Query!
State/province [94]
0
0
Cambridge
Query!
Country [95]
0
0
United Kingdom
Query!
State/province [95]
0
0
Cardiff
Query!
Country [96]
0
0
United Kingdom
Query!
State/province [96]
0
0
Glasgow
Query!
Country [97]
0
0
United Kingdom
Query!
State/province [97]
0
0
Leicester
Query!
Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
Liverpool
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
Manchester
Query!
Country [100]
0
0
United Kingdom
Query!
State/province [100]
0
0
Newcastle
Query!
Country [101]
0
0
United Kingdom
Query!
State/province [101]
0
0
Rhyl
Query!
Country [102]
0
0
United Kingdom
Query!
State/province [102]
0
0
Southampton
Query!
Country [103]
0
0
United Kingdom
Query!
State/province [103]
0
0
Stevenage
Query!
Country [104]
0
0
United Kingdom
Query!
State/province [104]
0
0
Wolverhampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
ECRI bv
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Biosensors International
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Commercial sector/Industry
Query!
Name [2]
0
0
AstraZeneca
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Commercial sector/Industry
Query!
Name [3]
0
0
The Medicines Company
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
After a stent procedure, it is common practice to prescribe anti-platelet medication to
prevent the blood from clotting. The main objective of this study is to determine if there is
a better medication strategy to prevent blood from clotting and at the same time minimising
the number of complications.
There are two medication strategies:
- Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month,
and then ticagrelor alone for another 23 months OR
- Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or
clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01813435
Query!
Trial related presentations / publications
Vranckx P, Valgimigli M, Juni P, Hamm C, Steg PG, Heg D, van Es GA, McFadden EP, Onuma Y, van Meijeren C, Chichareon P, Benit E, Mollmann H, Janssens L, Ferrario M, Moschovitis A, Zurakowski A, Dominici M, Van Geuns RJ, Huber K, Slagboom T, Serruys PW, Windecker S; GLOBAL LEADERS Investigators. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial. Lancet. 2018 Sep 15;392(10151):940-949. doi: 10.1016/S0140-6736(18)31858-0. Epub 2018 Aug 27.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Ernest Spitzer, MD
Query!
Address
0
0
European Cardiovascular Research Institute
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/NCT01813435
Download to PDF