Ethnic Differences and the Ischemia/Bleeding Risk of DAPT Duration

Coronary Artery Disease Clinical Trial

Official title:

Ethnic Differences in Ischemia/Bleeding Risk Tradeoff During Antiplatelet Therapy After Drug-eluting Stent Implantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03338335
• Other study ID #: DAPT
• Status: Active, not recruiting
• Phase: N/A
• First received: November 7, 2017
• Last updated: February 20, 2018
• Start date: March 1, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: February 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16000
• Est. completion date: October 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Dual Antiplatelet Therapy
• Ischemia
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Drug:
• prolonged DAPT
Dual antiplatelet therapy will be prescribed for more than 12 months

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary ischemic endpoint	major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis	2 years
Primary	primary bleeding endpoints	major bleeding events	2 years
Secondary	all-cause death		2 years
Secondary	cardiac death		2 years
Secondary	non-cardiac death		2 years
Secondary	any myocardial infarction		2 years
Secondary	any stroke		2 years