NCT00335452

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25,086 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Coronary Disease
• Angina Unstable

Interventions

Type	Name	Description
DRUG	Clopidogrel	oral administration
DRUG	acetylsalicyclic acid (ASA)	oral administration

Timeline

• Start date: 2006-06-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2006-06-09
• Last updated: 2010-11-18
• Results posted: 2010-10-07

Locations

38 sites across 38 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Estonia, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom