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Completed

NCT Number: NCT01186146

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soonchunhyang University Bucheon Hospital, Bucheon-si, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspirin monotherapy

Drug

stopping clopidogrel at 1 year after DES

Aspirin,Clopidogrel

Drug

continue aspirin and clopidogrel 1year after DES

Other names: Aspirin,Clopidogrel Dual antiplatelet therapy

Primary outcomes

  1. The composite of cardiac death, myocardial infarction, or stroke

    Time frame: at 2 year after randomization

Secondary outcomes

  1. death

    Time frame: at 2 year after randomization

  2. myocardial infarction

    Time frame: at 2 year after randomization

  3. stroke

    Time frame: at 2 year after randomization

  4. stent thrombosis

    Time frame: at 2 year after randomization

  5. Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding

    Time frame: at 2 year after randomization

  6. Target Vessl revascularization

    Time frame: at 2 year after randomization

  7. Target Lesion Revascularization

    Time frame: at 2 year after randomization

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

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

Acronym: DES-LATE

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Aug 23, 2010
Registry last updated
Mar 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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