Ethnic Differences and the Ischemia/Bleeding Risk of DAPT Duration

• Conditions: Percutaneous Coronary Intervention; Dual Antiplatelet Therapy; Coronary Artery Disease

• Registration Number: NCT03338335
• Lead Sponsor: Seoul National University Hospital

Brief Summary

this study is an individual patient level meta-analysis of randomized clinical trials, to evaluate the influence of ethnicity, to study whether the relative tradeoff between ischemia and bleeding is distinct by ethnicity.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-09
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22
• Primary Completion: 2018-03-31
• Study Completion: 2018-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16000

Inclusion Criteria

• patients enrolled in previous RCTs related to the duration of dural antiplatelet agent therapy

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
primary ischemic endpoint	2 years	major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis
primary bleeding endpoints	2 years	major bleeding events

Secondary Outcome Measures

Name	Time	Method
all-cause death	2 years
cardiac death	2 years
non-cardiac death	2 years
any myocardial infarction	2 years
any stroke	2 years

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of