Association of Clopidogrel Therapy and Stent Thrombosis

Coronary Artery Disease Clinical Trial

— REAL-LATE  

Official title:

Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated With Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484926
• Other study ID #: 20070186
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2007
• Last updated: August 9, 2012
• Start date: March 2007
• Est. completion date: March 2010

Study information

• Verified date: August 2012
• 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

The purpose of REAL-LATE (Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated with Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events) trial is to assess the relationship between clopidogrel use and long-term rates of cardiac death or MI after DES implantation in real-world practice and to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic events.

Description:

An observational analysis from BASKET-LATE (Basel Stent Kosten-Effekivitats Trial-Late Thrombotic Events) examined the incidence of clinical events after cessation of clopidogrel therapy. This study identified 746 patients who were without major adverse events 6 months after drug-eluting or bare-metal stent placement. All patients had stopped taking clopidogrel and were followed up for an additional 12 months. At 18-month follow-up, there was no difference between patients with a drug-eluting or bare-metal stent in cumulative rates of death or myocardial infarction (MI). However, after clopidogrel discontinuation patients receiving drug-eluting vs bare-metal stents experienced higher rates of death and MI (4.9% vs 1.3%, respectively). These results have created uncertainty regarding the minimal necessary duration of antiplatelet therapy after drug-eluting stent implantation. Also, there remains widespread uncertainty regarding the risk of clinical events after the discontinuation of clopidogrel, particularly after DES implantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Among consecutive patients treated with DES, event-free patients who survived at least the first 12 months without nonfatal MI or repeat revascularization

2. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. Contraindication to antiplatelet therapy (aspirin or clopidogrel)

2. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).

3. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

4. Concurrent bleeding diathesis or major bleeding history requiring discontinuation of antiplatelet drugs.

5. Patients with left main stem stenosis (>50% by visual estimate) or left main stenting

6. Concomitant disease requiring long-term use of clopidogrel (stroke, peripheral vascular disease, significant carotid a. disease, etc)

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	Choeng Ju St.Mary's Hospital	Choeng Ju
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Asan Medical Center	GangNeung
Korea, Republic of	DongGuk University Gyongju Hospital	Gyongju
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Kwangju Christian Hospital	Kwangju
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Hangang Sacred Heart Hospital	Seoul
Korea, Republic of	Kyungsang University Hospital	Seoul
Korea, Republic of	Seoul Veterans Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

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 or MI in the intent-to-treat population		1 year after randomization	Yes
Secondary	All death		1 year after randomization	Yes
Secondary	Myocardial infarction		1 year after randomization	Yes
Secondary	Stroke		1 year after randomization	Yes
Secondary	Stent Thrombosis		1 year after randomization	Yes
Secondary	Bleeding events		1 year after randomization	Yes