Association of Clopidogrel Therapy and Stent Thrombosis - Full Text View

Sponsored by:	CardioVascular Research Foundation, Korea
Information provided by:	CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:	NCT00484926

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Drug: Clopidogrel (Plavix)	Phase IV

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	Correlation of Clopidogrel Therapy Discontinuation in REAL-World Patients Treated With Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:

The composite of cardiac death or MI in the intent-to-treat population [ Time Frame: 1 year after randomization ]

Secondary Outcome Measures:

All death [ Time Frame: 1 year after randomization ]
Myocardial infarction [ Time Frame: 1 year after randomization ]
Stroke [ Time Frame: 1 year after randomization ]
Stent Thrombosis [ Time Frame: 1 year after randomization ]
Bleeding events [ Time Frame: 1 year after randomization ]

Estimated Enrollment:	2000
Study Start Date:	March 2007
Estimated Study Completion Date:	December 2008

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contraindication to antiplatelet therapy (aspirin or clopidogrel)
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).
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Concurrent bleeding diathesis or major bleeding history requiring discontinuation of antiplatelet drugs.
Patients with left main stem stenosis (>50% by visual estimate) or left main stenting
Concomitant disease requiring long-term use of clopidogrel (stroke, peripheral vascular disease, significant carotid a. disease, etc)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484926

Contacts

Contact: Seung-Jung Park, MD, PhD	2-3010-4812 ext 82	sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD, PhD	2-3010-3995 ext 82	dwpark@amc.seoul.kr

Locations

Korea, Republic of
Asan Medical Center	Recruiting
GangNeung, Korea, Republic of
Contact: Sang-Sig Cheong, MD, PhD
Principal Investigator: Sang-Sig Cheong, MD, PhD
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Seung-Jung Park, MD, PhD (82-2)-3010-4812 sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD, PhD (82-2)-3010-3995 dwpark@amc.seoul.kr
Principal Investigator: Seung-Jung Park, MD, PhD
Choeng Ju St.Mary’s Hospital	Recruiting
Choeng Ju, Korea, Republic of
Contact: Yong-Mo Yang, MD, PhD
Principal Investigator: Yong-Mo Yang, MD, PhD
Chonbuk National University Hospital	Recruiting
Jeonju, Korea, Republic of
Contact: Jae-Ki Ko, MD, PhD
Principal Investigator: Jae-Ki Ko, MD, PhD
Chungnam National University Hospital	Recruiting
Daejeon, Korea, Republic of
Contact: In-Whan Seong, MD, PhD
Principal Investigator: In-Whan Seong, MD, PhD
DongGuk University Gyongju Hospital	Recruiting
Gyongju, Korea, Republic of
Contact: Deuk Young Nah, MD, PhD
Principal Investigator: Deuk Young Nah, MD, PhD
Ulsan University Hospital	Recruiting
Ulsan, Korea, Republic of
Contact: Sang-Gon Lee, MD, PhD
Principal Investigator: Sang-Gon Lee, MD, PhD
Kangwon National University Hospital	Recruiting
Chuncheon, Korea, Republic of
Contact: Byoung Ryul Cho, MD, PhD
Principal Investigator: Byung Ryul Cho, MD, PhD
Kwangju Christian Hospital	Recruiting
Kwangju, Korea, Republic of
Contact: Seung-Wook Lee, MD, PhD
Principal Investigator: Seung-Wook Lee, MD, PhD
Kyungsang University Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Chung-Whan Kwak, MD, PhD
Seoul Veterans Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Keun Lee, MD, PhD
Principal Investigator: Keun Lee, MD, PhD
Soonchunhyang University Bucheon Hospital	Recruiting
Bucheon, Korea, Republic of
Contact: Nae-Hee Lee, MD, PhD
Principal Investigator: Nae-Hee Lee, MD, PhD
Hangang Sacred Heart Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Wo Jung Park, MD, PhD
Principal Investigator: Woo Jung Park, MD, PhD

Sponsors and Collaborators

CardioVascular Research Foundation, Korea

Investigators

Principal Investigator:

Seung-Jung Park, MD, PhD

Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

More Information

Study ID Numbers:	20070186
Study First Received:	June 11, 2007
Last Updated:	June 11, 2007
ClinicalTrials.gov Identifier:	NCT00484926
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:

stent
antiplatelet

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Clopidogrel
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Thrombosis
Coronary Artery Disease

Additional relevant MeSH terms:

Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009