Association of Clopidogrel Therapy and Stent Thrombosis

Condition(s) targeted: Coronary Artery Disease

Intervention: Clopidogrel (Plavix) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: CardioVascular Research Foundation, Korea

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

Overall contact:
Seung-Jung Park, MD, PhD, Phone: 2-3010-4812, Ext: 82, Email: sjpark@amc.seoul.kr

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.

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: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study

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.

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)

Seung-Jung Park, MD, PhD, Phone: 2-3010-4812, Ext: 82, Email: sjpark@amc.seoul.kr

Asan Medical Center, GangNeung, Korea, Republic of; Recruiting
Sang-Sig Cheong, MD, PhD
Sang-Sig Cheong, MD, PhD, Principal Investigator

Asan Medical Center, Seoul 138-736, Korea, Republic of; Recruiting
Seung-Jung Park, MD, PhD, Phone: (82-2)-3010-4812, Email: sjpark@amc.seoul.kr
Duk-Woo Park, MD, PhD, Phone: (82-2)-3010-3995, Email: dwpark@amc.seoul.kr
Seung-Jung Park, MD, PhD, Principal Investigator

Choeng Ju St.Mary’s Hospital, Choeng Ju, Korea, Republic of; Recruiting
Yong-Mo Yang, MD, PhD
Yong-Mo Yang, MD, PhD, Principal Investigator

Chonbuk National University Hospital, Jeonju, Korea, Republic of; Recruiting
Jae-Ki Ko, MD, PhD
Jae-Ki Ko, MD, PhD, Principal Investigator

Chungnam National University Hospital, Daejeon, Korea, Republic of; Recruiting
In-Whan Seong, MD, PhD
In-Whan Seong, MD, PhD, Principal Investigator

DongGuk University Gyongju Hospital, Gyongju, Korea, Republic of; Recruiting
Deuk Young Nah, MD, PhD
Deuk Young Nah, MD, PhD, Principal Investigator

Hangang Sacred Heart Hospital, Seoul, Korea, Republic of; Recruiting
Wo Jung Park, MD, PhD
Woo Jung Park, MD, PhD, Principal Investigator

Kangwon National University Hospital, Chuncheon, Korea, Republic of; Recruiting
Byoung Ryul Cho, MD, PhD
Byung Ryul Cho, MD, PhD, Principal Investigator

Kwangju Christian Hospital, Kwangju, Korea, Republic of; Recruiting
Seung-Wook Lee, MD, PhD
Seung-Wook Lee, MD, PhD, Principal Investigator

Kyungsang University Hospital, Seoul, Korea, Republic of; Recruiting
Chung-Whan Kwak, MD, PhD

Seoul Veterans Hospital, Seoul, Korea, Republic of; Recruiting
Keun Lee, MD, PhD
Keun Lee, MD, PhD, Principal Investigator

Soonchunhyang University Bucheon Hospital, Bucheon, Korea, Republic of; Recruiting
Nae-Hee Lee, MD, PhD
Nae-Hee Lee, MD, PhD, Principal Investigator

Ulsan University Hospital, Ulsan, Korea, Republic of; Recruiting
Sang-Gon Lee, MD, PhD
Sang-Gon Lee, MD, PhD, Principal Investigator

Starting date: March 2007
Ending date: December 2008
Last updated: June 11, 2007