Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
CardioVascular Research Foundation, Korea Korea Otsuka International Asia Arab |
---|---|
Information provided by: | CardioVascular Research Foundation, Korea |
ClinicalTrials.gov Identifier: | NCT00589927 |
To evaluate whether the cilostazol reduce neointimal hyperplasia after ZES (Zotarolimus-eluting stents) implantation, we performed double-blind,randomized, multicenter, prospective study compared triple antiplatelet therapy (aspirin plus clopidogrel plus cilostazol) and dual antiplatelet therapy (aspirin plus clopidogrel) for 8 months in patients with long coronary lesion treated with ZES.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Drug: Cilostazol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparision of Triple Verus Dual Antiplatelet Therapy After ABT578-Eluting Stent Implnatation For Long Coronary Lesions |
Estimated Enrollment: | 486 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A1: Experimental
Cilostazol
|
Drug: Cilostazol
Phosphodiesterase inhibitor
|
A2: Placebo Comparator
Control placebo
|
Drug: Cilostazol
Phosphodiesterase inhibitor
|
Use of drug-eluting stent (DES) has reduced the incidence of restenosis rate and the need for repeat revascularization compared to using bare metal stents. DES implantation also significantly reduced the angiographic restenosis in patients with long coronary lesions.However, although the use of DES has decreased the effect of lesion length on restenosis, the restenosis after DES implantation of long coronary lesions remain at a higher risk of restenosis. Cilostazol, a phosphodiesterase III inhibitor, has been known to reduce smooth muscle proliferation and intimal hyperplasia after endothelial injury and restenosis after balloon angioplasty and bare-metal stent (BMS) implantation when compared with aspirin and clopidogrel or ticlopidine. Recently, the impact of 6-month cilostazol treatment in addition to aspirin and clopidogrel on neointimal hyperplasia after sirolimus-(SES) or paclitaxel-eluting stent (PES) implantation for long-coronary lesions has been evaluated in our institution. It reported that cilostazol treatment achieved primary end point (in-stent late loss) and reduced need of target lesion revascularization without significant adverse drug-side effects with open-label design, which suggest that 6-month treatment of cilostazol effectively inhibits the neointimal hyperplasia after DES implantation and can be safely applied to the patients or lesions with higher risk of restenosis such as diabetes and long lesions.However, our study was done in unblined manner and might underestimate the angiographic results due to relatively short-term follow-up angiographic follow-up(6-month.
Recently commercially available new-DES, zotarolimus-leuting stent (ZES) demonstrated significant reduction of restenosis and cardiac events during 9-month. However, it has not been tested that 8-month treatment of cilostazol also effectively inhibits the neointimal hyperplasia after ZES implantation in patients with long coronary lesions. Therefore, to evaluate whether the cilostazol reduce neointimal hyperplasia after ZES implantation, We performed double-blind, randomized, multicenter, prospective study compared triple antiplatelet therapy (aspirin plus clopidogrel plus cilostazol) and dual antiplatelet therapy (aspirin plus clopidogrel) for 8 months in patients with long coronary lesion treated with ZES.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Seong-Wook Park, MD, PhD | 2-3010-3153 ext 82 | swpark@amc.seoul.kr |
Contact: Seung-Whan Lee, MD, PhD | 2-3010-3170 ext 82 | seungwlee@amc.seoul.kr |
Korea, Republic of | |
Asan Medical Center | Recruiting |
Seoul, Korea, Republic of, 138-736 | |
Contact: Seong-Wook Park, MD, PhD 2-3010-3153 ext 82 swpark@amc.seoul.kr | |
Contact: Seung-Whan Lee, MD, PhD 2-3010-3170 ext 82 seungwlee@amc.seoul.kr | |
Principal Investigator: Seong-Wook Park, DM, PhD | |
Chungnam National University Hospital | Recruiting |
Daejeon, Korea, Republic of | |
Contact: In-Whan Seong, MD, PhD | |
Principal Investigator: In-Whan Seong, MD, PhD | |
Hangang Sacred Heart Hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: Min-Gyu Kim, MD | |
Principal Investigator: Min-Gyu Kim, MD | |
Kangwon National University Hospital | Recruiting |
Chuncheon, Korea, Republic of | |
Contact: Bong-Ki Lee, MD, PhD | |
Principal Investigator: Bong-Ki Lee, MD, PhD | |
Seoul Veterans Hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: Keun Lee, MD, PhD | |
Principal Investigator: Keun Lee, MD, PhD | |
Soonchunhyang University Hospital, Cheonan | Recruiting |
Cheonan, Korea, Republic of | |
Contact: Dong-Gyu Jin, MD, PhD | |
Principal Investigator: Dong-Gyu Jin, MD, PhD | |
Hallym University Sacred Heart Hospital, | Recruiting |
PyeongChon, Korea, Republic of | |
Contact: Young-Jin Choi, MD, PhD | |
Principal Investigator: Young-Jin Choi, MD, PhD | |
Soonchunhyang University Bucheon Hospital | Recruiting |
Bucheon, Korea, Republic of | |
Contact: Nae-Hee Lee, MD, PhD | |
Principal Investigator: Nae-Hee Lee, MD, PhD | |
Soonchunhyang University Seoul Hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: Min-Su Hyun, MD, PhD | |
Principal Investigator: Min-Su Hyun, MD, PhD | |
Ulsan University Hospital | Recruiting |
Ulsan, Korea, Republic of | |
Contact: Sang-Gon Lee, MD, PhD | |
Principal Investigator: Sang-Gon Lee, MD, PhD |
Principal Investigator: | Seung-Wook Park, MD,PhD | Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine |
Responsible Party: | Asan Medical Center ( Seong-Wook Park, MD, PhD ) |
Study ID Numbers: | 2007-0003 |
Study First Received: | December 31, 2007 |
Last Updated: | December 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00589927 History of Changes |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
stents cilostazol |
Arterial Occlusive Diseases Cilostazol Vasodilator Agents Heart Diseases Myocardial Ischemia Vascular Diseases Anti-Asthmatic Agents Fibrinolytic Agents Cardiovascular Agents Ischemia |
Arteriosclerosis Neuroprotective Agents Coronary Disease Fibrin Modulating Agents Phosphodiesterase Inhibitors Platelet Aggregation Inhibitors Peripheral Nervous System Agents Bronchodilator Agents Coronary Artery Disease |
Respiratory System Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Physiological Effects of Drugs Hematologic Agents Fibrinolytic Agents Arteriosclerosis Neuroprotective Agents Fibrin Modulating Agents Therapeutic Uses Cardiovascular Diseases Arterial Occlusive Diseases Cilostazol Heart Diseases |
Vascular Diseases Anti-Asthmatic Agents Enzyme Inhibitors Cardiovascular Agents Protective Agents Pharmacologic Actions Coronary Disease Phosphodiesterase Inhibitors Autonomic Agents Platelet Aggregation Inhibitors Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents Coronary Artery Disease |