NCT00335452|CompletedPhase 3ResultsDMC

Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS

CURRENT/OASIS7

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.

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC5965EUDRACT: 2006-000313-38

Study Type

interventional

Target

25,086

Locations

36 countries

Sites

Timeline

RegisteredJun 2006

StartedJun 2006

CompletionSep 2009

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 Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

25,086

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jun 2006

Typical duration for phase_3

Geographic Reach

36 countries

36 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

Study Start

First participant enrolled

June 1, 2006

Completed

7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2006

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

October 7, 2010

Completed

Last Updated

November 18, 2010

Status Verified

November 1, 2010

Enrollment Period

3.3 years

First QC Date

June 8, 2006

Results QC Date

September 15, 2010

Last Update Submit

November 9, 2010

Conditions

Acute Coronary Disease Angina Unstable

Keywords

platelet aggregation inhibitorsacute coronary diseasepercutaneous coronary

Outcome Measures

Primary Outcomes (4)

First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison
The primary endpoint is the first occurrence of any of the following events: * Cardiovascular death (any death with a clear cardiovascular or unknown cause), * Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal) * Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal) reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC).
30 days
First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison
30 days
First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level
30 days
First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup
30 days

Secondary Outcomes (2)

Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison
30 days
Occurrence of Major Bleeding - ASA Dose Level Comparison
30 days

Study Arms (4)

Clopidogrel high dose treatment regimen + ASA high dose

EXPERIMENTAL

Drug: ClopidogrelDrug: acetylsalicyclic acid (ASA)

Clopidogrel high dose treatment regimen + ASA low dose

EXPERIMENTAL

Drug: ClopidogrelDrug: acetylsalicyclic acid (ASA)

Clopidogrel standard treatment regimen + ASA high dose

ACTIVE COMPARATOR

Drug: ClopidogrelDrug: acetylsalicyclic acid (ASA)

Clopidogrel standard treatment regimen + ASA low dose

ACTIVE COMPARATOR

Drug: ClopidogrelDrug: acetylsalicyclic acid (ASA)

Interventions

ClopidogrelDRUG

oral administration

Also known as: SR25990, Plavix

Clopidogrel high dose treatment regimen + ASA high doseClopidogrel high dose treatment regimen + ASA low doseClopidogrel standard treatment regimen + ASA high doseClopidogrel standard treatment regimen + ASA low dose

acetylsalicyclic acid (ASA)DRUG

oral administration

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosed with acute coronary disease with clinical symptoms and at least electrocardiogram changes or cardiac enzymes elevated

You may not qualify if:

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

Contact the study team to confirm eligibility.