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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/NCT00335452




Registration number
NCT00335452
Ethics application status
Date submitted
8/06/2006
Date registered
9/06/2006
Date last updated
18/11/2010

Titles & IDs
Public title
Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS
Scientific title
Randomized, Multinational, Double-blind Study, Comparing a High Loading Dose Regimen of Clopidogrel Versus Standard Dose in Patients With Unstable Angina or Myocardial Infarction Managed With an Early Invasive Strategy.
Secondary ID [1] 0 0
EUDRACT: 2006-000313-38
Secondary ID [2] 0 0
EFC5965
Universal Trial Number (UTN)
Trial acronym
CURRENT/OASIS7
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Disease 0 0
Angina Unstable 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

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

Experimental: Clopidogrel high dose treatment regimen + ASA high dose -

Experimental: Clopidogrel high dose treatment regimen + ASA low dose -

Active Comparator: Clopidogrel standard treatment regimen + ASA high dose -

Active Comparator: Clopidogrel standard treatment regimen + ASA low dose -


Treatment: Drugs: Clopidogrel
oral administration

Treatment: Drugs: acetylsalicyclic acid (ASA)
oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level
Timepoint [3] 0 0
30 days
Primary outcome [4] 0 0
First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup
Timepoint [4] 0 0
30 days
Secondary outcome [1] 0 0
Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
Occurrence of Major Bleeding - ASA Dose Level Comparison
Timepoint [2] 0 0
30 days

Eligibility
Key inclusion criteria
- Diagnosed with acute coronary disease with clinical symptoms and at least
electrocardiogram changes or cardiac enzymes elevated
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Use of anticoagulants within 10 days with an international normalized ratio (INR) >
1.5 or planned use during the hospitalisation period

- Administration of clopidogrel > 75 mg prior to randomization

- Contraindication to clopidogrel or aspirin

- Active bleeding or significant risk of bleeding

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
Factorial
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
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2009
Sample size
Target
Accrual to date
Final
25086
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
sanofi-aventis Australia & New Zealand administrative office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Belgium
State/province [4] 0 0
Diegem
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Sofia
Country [7] 0 0
Canada
State/province [7] 0 0
Laval
Country [8] 0 0
Chile
State/province [8] 0 0
Santiago de Chile
Country [9] 0 0
China
State/province [9] 0 0
Beijing
Country [10] 0 0
Croatia
State/province [10] 0 0
Zagreb
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Praha
Country [12] 0 0
Estonia
State/province [12] 0 0
Tallinn
Country [13] 0 0
Finland
State/province [13] 0 0
Helsinki
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Greece
State/province [16] 0 0
Athens
Country [17] 0 0
India
State/province [17] 0 0
Mumbai
Country [18] 0 0
Ireland
State/province [18] 0 0
Dublin
Country [19] 0 0
Israel
State/province [19] 0 0
Natanya
Country [20] 0 0
Italy
State/province [20] 0 0
Milano
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seoul
Country [22] 0 0
Latvia
State/province [22] 0 0
Riga
Country [23] 0 0
Lithuania
State/province [23] 0 0
Vilnius
Country [24] 0 0
Malaysia
State/province [24] 0 0
Kuala Lumpur
Country [25] 0 0
Mexico
State/province [25] 0 0
Mexico
Country [26] 0 0
Netherlands
State/province [26] 0 0
Gouda
Country [27] 0 0
Poland
State/province [27] 0 0
Warszawa
Country [28] 0 0
Romania
State/province [28] 0 0
Bucuresti
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Moscow
Country [30] 0 0
Singapore
State/province [30] 0 0
Singapore
Country [31] 0 0
Slovakia
State/province [31] 0 0
Brastislava
Country [32] 0 0
South Africa
State/province [32] 0 0
Midrand
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Sweden
State/province [34] 0 0
Bromma
Country [35] 0 0
Switzerland
State/province [35] 0 0
Geneva
Country [36] 0 0
Turkey
State/province [36] 0 0
Istanbul
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin
(two doses) will decrease the risk of ischemic complications (cardiac death (CV death),
myocardial infarction (MI), stroke) after a percutaneous coronary intervention (PCI).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00335452
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shamir MEHTA, MD
Address 0 0
Hamilton General Hospital, McMaster University, CANADA
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/NCT00335452