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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00391872




Registration number
NCT00391872
Ethics application status
Date submitted
23/10/2006
Date registered
25/10/2006
Date last updated
13/03/2012

Titles & IDs
Public title
A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome
Scientific title
A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of Ticagrelor Compared With Clopidogrel for Prevention of Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO- a Study of PLATelet Inhibition and Patient Outcomes]
Secondary ID [1] 0 0
PLATO
Secondary ID [2] 0 0
D5130C05262
Universal Trial Number (UTN)
Trial acronym
PLATO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ticagrelor
Treatment: Drugs - Clopidogrel

Active Comparator: Clopidogrel - Oral treatment

Experimental: Ticagrelor - Oral treatment


Treatment: Drugs: Ticagrelor
Ticagrelor (AZD6140) 90 mg twice daily dose (BD)

Treatment: Drugs: Clopidogrel
Clopidogrel 75 mg once daily dose (ODD)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke
Timepoint [1] 0 0
Randomization up to 12 months
Primary outcome [2] 0 0
Participants With Any Major Bleeding Event
Timepoint [2] 0 0
First dosing up to 12 months
Secondary outcome [1] 0 0
Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization
Timepoint [1] 0 0
Randomization up to 12 months
Secondary outcome [2] 0 0
Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke
Timepoint [2] 0 0
Randomization up to 12 months
Secondary outcome [3] 0 0
Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.
Timepoint [3] 0 0
Randomization up to 12 months
Secondary outcome [4] 0 0
Participants With MI Event
Timepoint [4] 0 0
Randomization up to 12 months
Secondary outcome [5] 0 0
Participants With Death From Vascular Causes
Timepoint [5] 0 0
Randomization up to 12 months
Secondary outcome [6] 0 0
Participants With Stroke
Timepoint [6] 0 0
Randomization up to 12 months
Secondary outcome [7] 0 0
Participants With Death From Any Cause
Timepoint [7] 0 0
Randomization up to 12 months
Secondary outcome [8] 0 0
Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding
Timepoint [8] 0 0
First dosing up to 12 months
Secondary outcome [9] 0 0
Participants With Major or Minor Bleeding
Timepoint [9] 0 0
First dosing up to 12 months
Secondary outcome [10] 0 0
Participants With Non-procedural Major Bleeding
Timepoint [10] 0 0
First dosing up to 12 months
Secondary outcome [11] 0 0
Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding
Timepoint [11] 0 0
First dosing up to 12 months
Secondary outcome [12] 0 0
Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding
Timepoint [12] 0 0
First dosing up to 12 months
Secondary outcome [13] 0 0
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization
Timepoint [13] 0 0
1-week period following randomization
Secondary outcome [14] 0 0
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization
Timepoint [14] 0 0
1-week period following randomization

Eligibility
Key inclusion criteria
- Male or female 18 years or older who has been hospitalised for chest pain and
potential ACS

- Females of child-bearing potential must have a negative pregnancy test at enrollment
and be willing to use 2 methods of reliable contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Persons with moderate or severe liver disease

- Persons who have already been treated with an invasive (angioplasty) procedure for the
current episode of ACS

- Persons who are being treated with blood clotting agents that cannot be stopped

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2009
Sample size
Target
Accrual to date
Final
18624
Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA,VIC,WA
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- Dandenong
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- Geelong
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- Melbourne
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- Perth
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Germany
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Germany
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Germany
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Merseburg
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Germany
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Germany
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Muhlheim An Der Ruhr
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Germany
State/province [223] 0 0
Munster
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Germany
State/province [224] 0 0
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Germany
State/province [225] 0 0
Rostock
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Germany
State/province [226] 0 0
ULM
Country [227] 0 0
Germany
State/province [227] 0 0
Warendorf
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Germany
State/province [228] 0 0
Witten
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Germany
State/province [229] 0 0
Wuppertal
Country [230] 0 0
Germany
State/province [230] 0 0
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Country [231] 0 0
Greece
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Crete
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Greece
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Athens
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Greece
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Larissa
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Greece
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Patra
Country [235] 0 0
Greece
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Piraeus
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Greece
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Country [237] 0 0
Hong Kong
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Hong Kong
Country [238] 0 0
Hungary
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Budapest
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Hungary
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Cegled
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Hungary
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Debrecen
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Hungary
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Gyula
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Hungary
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Hodmez-vasarhely
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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India
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Andhrapradesh
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India
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Delhi
Country [251] 0 0
India
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Gujarat
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India
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Karnataka
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India
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Kerala
Country [254] 0 0
India
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Madhya Pradesh
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India
State/province [255] 0 0
Maharashtra
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India
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Punjab
Country [257] 0 0
India
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Rajasthan
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India
State/province [258] 0 0
Tamilnadu
Country [259] 0 0
India
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West Bengal
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Indonesia
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Bali
Country [261] 0 0
Indonesia
State/province [261] 0 0
Jawa Barat
Country [262] 0 0
Indonesia
State/province [262] 0 0
Jawa Timur
Country [263] 0 0
Indonesia
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Jakarta
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Indonesia
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Makassar
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Indonesia
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Semarang
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Israel
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Afula
Country [267] 0 0
Israel
State/province [267] 0 0
Ashkelon
Country [268] 0 0
Israel
State/province [268] 0 0
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Country [269] 0 0
Israel
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Hadera
Country [270] 0 0
Israel
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Haifa
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Israel
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Israel
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Jerusalem
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Israel
State/province [273] 0 0
Poriya M.p. Lower Galilee
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Israel
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Israel
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Tel Aviv
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Israel
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Italy
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AN
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Italy
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BA
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Italy
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BG
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Italy
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CE
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CT
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FG
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SS
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VE
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VR
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Massa Carrara
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Italy
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Wilayah Persekutuan
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Mexico
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Mexico
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Mexico
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Mexico
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Netherlands
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Netherlands
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Netherlands
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RUD
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Philippines
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Poland
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Poland
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Poland
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Poland
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Poland
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Elblag
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Lublin
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Poland
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Poland
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Poland
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Poland
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Ostrowiec Swietokrzyski
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Poland
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Plock
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Poland
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Poznan
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Poland
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Radom
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Poland
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Poland
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Tarnow
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Poland
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Torun
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Poland
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Walbrzych
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Poland
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Poland
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Wejherowo
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Poland
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Wloclawek
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Poland
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Wroclaw
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Poland
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Portugal
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Portugal
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Aveiro
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Portugal
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Braga
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Portugal
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Coimbra
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Portugal
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Leiria
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Portugal
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Lisboa
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Portugal
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Portugal
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Santa Maria Da Feira
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Portugal
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Santarem
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Portugal
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Country [411] 0 0
Portugal
State/province [411] 0 0
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Country [412] 0 0
Portugal
State/province [412] 0 0
Vila Real
Country [413] 0 0
Puerto Rico
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San Juan
Country [414] 0 0
Romania
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Romania
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Cluj
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Romania
State/province [416] 0 0
Braila
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Romania
State/province [417] 0 0
Brasov
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Romania
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Bucharest
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Romania
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Romania
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Romania
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Iasi
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Romania
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Suceava
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Russian Federation
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Khanty-mansiysk Autonomous Dis
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Russian Federation
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Barnaul
Country [425] 0 0
Russian Federation
State/province [425] 0 0
Ekaterinburg
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Russian Federation
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Irkutsk
Country [427] 0 0
Russian Federation
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Kaliningrad
Country [428] 0 0
Russian Federation
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Kazan
Country [429] 0 0
Russian Federation
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Kemerovo
Country [430] 0 0
Russian Federation
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Krasnodar
Country [431] 0 0
Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Murmansk
Country [434] 0 0
Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Rostov-na-donu
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Russian Federation
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Samara
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Tyumen
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Russian Federation
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Singapore
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Singapore
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Liptovsky Mikulas
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Slovakia
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Martin
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Slovakia
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Nitra
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Slovakia
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Nove Zamky
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Slovakia
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Piestany
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Slovakia
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Ruzomberok
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Slovakia
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Trnava
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Slovakia
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Zilina
Country [453] 0 0
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Cape Town
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South Africa
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Free State
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Pretoria
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Spain
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Spain
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Spain
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Cataluna
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Spain
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Comunidad de Madrid
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Spain
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Comunidad Valenciana
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Spain
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Spain
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Spain
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Islas Baleares
Country [464] 0 0
Sweden
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Boras
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Sweden
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Eksjo
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Sweden
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Eskilstuna
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Sweden
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Falun
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Sweden
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Halmstad
Country [469] 0 0
Sweden
State/province [469] 0 0
Jonkoping
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Sweden
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Country [471] 0 0
Sweden
State/province [471] 0 0
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Sweden
State/province [472] 0 0
Lidkoping
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Sweden
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Linkoping
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Sweden
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Ljungby
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Sweden
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Lund
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Sweden
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Ostersund
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Sweden
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Country [478] 0 0
Sweden
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Stockholm
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Sweden
State/province [479] 0 0
Sundsvall
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Sweden
State/province [480] 0 0
Uppsala
Country [481] 0 0
Sweden
State/province [481] 0 0
Vasteras
Country [482] 0 0
Switzerland
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Ticino
Country [483] 0 0
Switzerland
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Bellinzona
Country [484] 0 0
Switzerland
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Bern
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Switzerland
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Switzerland
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Kreuzlingen
Country [487] 0 0
Switzerland
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Lugano
Country [488] 0 0
Taiwan
State/province [488] 0 0
Kaohsiung
Country [489] 0 0
Taiwan
State/province [489] 0 0
Taoyuan Hsien
Country [490] 0 0
Taiwan
State/province [490] 0 0
Taipei
Country [491] 0 0
Thailand
State/province [491] 0 0
Bangkok
Country [492] 0 0
Thailand
State/province [492] 0 0
Chiang Mai
Country [493] 0 0
Thailand
State/province [493] 0 0
Khon Kaen
Country [494] 0 0
Turkey
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Kartal
Country [495] 0 0
Turkey
State/province [495] 0 0
Sihhiye
Country [496] 0 0
Turkey
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Adana
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Turkey
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Antalya
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Turkey
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Mersin
Country [499] 0 0
Ukraine
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Dnepropetrovsk
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Ukraine
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Donetsk
Country [501] 0 0
Ukraine
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Kharkov
Country [502] 0 0
Ukraine
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Kiev
Country [503] 0 0
Ukraine
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Makiyivka
Country [504] 0 0
United Kingdom
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Country [505] 0 0
United Kingdom
State/province [505] 0 0
Northern Ireland
Country [506] 0 0
United Kingdom
State/province [506] 0 0
Basingstoke
Country [507] 0 0
United Kingdom
State/province [507] 0 0
Birmingham
Country [508] 0 0
United Kingdom
State/province [508] 0 0
Blackpool
Country [509] 0 0
United Kingdom
State/province [509] 0 0
Dundee
Country [510] 0 0
United Kingdom
State/province [510] 0 0
Edinburgh
Country [511] 0 0
United Kingdom
State/province [511] 0 0
Glasgow
Country [512] 0 0
United Kingdom
State/province [512] 0 0
Leicester
Country [513] 0 0
United Kingdom
State/province [513] 0 0
London
Country [514] 0 0
United Kingdom
State/province [514] 0 0
Manchester
Country [515] 0 0
United Kingdom
State/province [515] 0 0
Middlesborough
Country [516] 0 0
United Kingdom
State/province [516] 0 0
Poole
Country [517] 0 0
United Kingdom
State/province [517] 0 0
Sheffield
Country [518] 0 0
United Kingdom
State/province [518] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications
work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment
for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both
heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by
the formation of a blood clot in an artery that partially or totally blocks the blood supply
to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine
which drug, when either is used in conjunction with aspirin, is better at reducing deaths
from vascular causes, future heart attacks and/or strokes in patients with ACS.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00391872
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Harrington, MD
Address 0 0
Duke Clinical Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00391872