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

Optimal Duration of Clopidogrel Therapy After Drug-Eluting Stent Implantation to Reduce Late Coronary Arterial Thrombotic Events

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01186146

Acronym

DES-LATE

Enrollment

5000

Registered

2010-08-23

Start date

2010-08-31

Completion date

2013-10-31

Last updated

2014-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

coronary disease, stents, antiplatelet drugs, drug-eluting stents

Brief summary

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.

Detailed 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.

Interventions

DRUGAspirin monotherapy

stopping clopidogrel at 1 year after DES

DRUGAspirin,Clopidogrel

continue aspirin and clopidogrel 1year after DES

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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. * 2\. 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.

Design outcomes

Primary

Measure	Time frame
The composite of cardiac death, myocardial infarction, or stroke	at 2 year after randomization

Secondary

Measure	Time frame
myocardial infarction	at 2 year after randomization
stroke	at 2 year after randomization
stent thrombosis	at 2 year after randomization
death	at 2 year after randomization
Target Vessl revascularization	at 2 year after randomization
Target Lesion Revascularization	at 2 year after randomization
Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding	at 2 year after randomization

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026