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

Coronary Artery Disease Clinical Trial

— DES-LATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186146
• Other study ID #: 2007-0186
• Status: Completed
• Phase: Phase 4
• First received: August 17, 2010
• Last updated: March 19, 2014
• Start date: August 2010
• Est. completion date: October 2013

Study information

• Verified date: March 2014
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: October 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Aspirin monotherapy
stopping clopidogrel at 1 year after DES
• Aspirin,Clopidogrel
continue aspirin and clopidogrel 1year after DES

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon
Korea, Republic of	Busan Saint Mary's Hospital	Busan
Korea, Republic of	Cheongju Saint Mary's Hospital	Cheongju
Korea, Republic of	Chungju ST.Mary's Hospital	Cheongju
Korea, Republic of	Kangwon National University Hospital	Chooncheon
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Asan Medical Center	GangNeung
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	DongGuk University Gyongju Hospital	Gyongju
Korea, Republic of	NHIC Ilsan Hospital	Ilsan
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Catholic University, Kangnam St. Mary's Hospital	Seoul
Korea, Republic of	Hangang Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Korea Veterans Hospital	Seoul
Korea, Republic of	St.Mary's Catholic Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite of cardiac death, myocardial infarction, or stroke		at 2 year after randomization	Yes
Secondary	death		at 2 year after randomization	Yes
Secondary	myocardial infarction		at 2 year after randomization	Yes
Secondary	stroke		at 2 year after randomization	Yes
Secondary	stent thrombosis		at 2 year after randomization	Yes
Secondary	Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding		at 2 year after randomization	Yes
Secondary	Target Vessl revascularization		at 2 year after randomization	No
Secondary	Target Lesion Revascularization		at 2 year after randomization	No