Phase 3 N=25,086 Randomized Quadruple-blind Treatment

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

Acute Coronary Disease · Angina Unstable

Bottom Line

View on ClinicalTrials.gov: NCT00335452 ↗

Enrolled (actual)

25,086

Serious AEs

5.4%

Results posted

Oct 2010

Primary outcome: Primary: First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison — 557; 522; 222; 226 participants — p=0.3037

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Clopidogrel (Drug); acetylsalicyclic acid (ASA) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sanofi
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison	557; 522; 222; 226; 274; 237	0.3037
PRIMARY First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison	546; 527; 231; 211; 260; 251	0.6047
PRIMARY First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level	267; 290; 282; 240	0.4579
PRIMARY First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup	392; 330; 132; 130; 225; 172	0.0332 sig
SECONDARY Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison	255; 313; 195; 236; 65; 83	0.012 sig
SECONDARY Occurrence of Major Bleeding - ASA Dose Level Comparison	285; 282; 215; 216; 74; 73	0.945

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).

Eligibility Criteria

Inclusion Criteria

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00335452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.