NCT01294462

Study to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)

A Randomised, Double-blind, Double-dummy, Parallel Group, International (Asian), Multicenter, Phase 3 Study to Assess Safety and Efficacy of AZD6140 on Top of Low Dose Acetyl Salicylic Acid (ASA) Versus Clopidogrel on Top of Low Dose ASA in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes(ACS) for Whom PCI is Planned

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 801 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the efficacy (prevention of vascular events) and safety (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given on top of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a planned percutaneous coronary intervention (PCI).

Conditions

• Acute Coronary Syndrome
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DRUG	Ticagrelor	90 mg, oral dose twice daily
DRUG	Clopidogrel	75 mg, oral dose once daily
DRUG	Acetylsalicylic acid ASA	Low Dose ASA

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-02-11
• Last updated: 2014-06-27
• Results posted: 2014-05-02

Locations

87 sites across 3 countries: Japan, South Korea, Taiwan