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Sponsored by: |
CardioVascular Research Foundation, Korea |
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Information provided by: | CardioVascular Research Foundation, Korea |
ClinicalTrials.gov Identifier: | NCT00484926 |
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 |
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Coronary Artery Disease |
Drug: Clopidogrel (Plavix) |
Phase IV |
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 |
Estimated Enrollment: | 2000 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | December 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Seung-Jung Park, MD, PhD | Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine |
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) |
stent antiplatelet |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Clopidogrel Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Thrombosis Coronary Artery Disease |
Therapeutic Uses Hematologic Agents Platelet Aggregation Inhibitors Cardiovascular Diseases Pharmacologic Actions |