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Association of Clopidogrel Therapy and Stent Thrombosis

Information source: CardioVascular Research Foundation, Korea
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: Aspirin monotherapy (Drug); Aspirin,Clopidogrel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Seung-Jung Park

Official(s) and/or principal investigator(s):
Seung-Jung Park, MD, PhD, Principal Investigator, Affiliation: Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

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.

Clinical Details

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

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

Primary outcome: The composite of cardiac death or MI in the intent-to-treat population

Secondary outcome:

All death

Myocardial infarction

Stroke

Stent Thrombosis

Bleeding events

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Locations and Contacts

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 138-736, 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, Korea, Republic of

Additional Information

Starting date: March 2007
Last updated: August 9, 2012

Page last updated: August 20, 2015

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