Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE)

Seung-Jung Park

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: Aspirin,Clopidogrel

Drug: Aspirin monotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01186146

2007-0186

Details and patient eligibility

About

This is randomized-controlled trial to evaluate the difference of composite of cardiac death, myocardial infarction, or Stroke between the dual antiplatelet therapy group and the aspirin monotherapy group after 1-year of drug-eluting stents implantation.

Full description

This is subsequent clinical trial of previously published pooled analysis of the REAL-LATE and the ZEST-LATE Trial, in which nonsignificant higher trend for increased rate of death (all-cause and cardiac), myocardial infarction, or stroke in the dual antiplatelet therapy group compared to the aspirin monotherapy group was noted.

Enrollment

5,000 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Patients had undergone DES implantation at least 12 months before enrollment, had not had a MACE (death, MI, stroke, or repeat revascularization) or major bleeding, and were dual-therapy at the time of enrollment.
1. Time for index PCI to randomization: 12-18 months

Exclusion criteria

Contraindications to the use of antiplatelet drugs (e.g., a concurrent bleeding diathesis or a history of major bleeding)
Concomitant vascular disease requiring long-term use of clopidogrel
Other established indications for clopidogrel therapy (e.g., a recent ACS).
Noncardiac coexisting conditions with a life expectancy < 1 year.