Drug-Eluting Stenting Followed by Cilostazol tREAtment Reduces SErious Adverse Cardiac Events (DECREASE-PCI)
Information source: CardioVascular Research Foundation, Korea
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Cilostazol (Drug); Placebo (Drug)
Phase: Phase 4
Status: Active, not recruiting
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 DECREASE-PCI trial is a prospective, randomized, placebo controlled, double-blind, phase
4 study to evaluate efficacy and safety of triple anti-platelet therapy compared with dual
antiplatelet therapy in patients treated with DES for Coronary Artery Disease.
The primary objective of this study is to compare the safety and efficacy of triple
antiplatelet therapy versus dual (standard) antiplatelet therapy in patients treated with
drug-eluting stent (DES) implantation for the treatment of coronary artery disease.
Clinical Details
Official title: A Randomized, Placebo Controlled, Double-blind, Phase 4 Study to Evaluate Efficacy and Safety of Triple Anti-platelet Therapy Compared With Dual Antiplatelet Therapy in Patients Treated With Drug Eluting Stent for Coronary Artery Disease
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Major Adverse Cardiac and Cerebrovascular Ischemic Events (MACCE)
Secondary outcome: Major Adverse Cardiac Events (MACE)
Detailed description:
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 (BMS). Therefore, DES
implantation has been default strategy in the treatment of coronary artery disease. However,
despite use of DES, the restenosis, subsequent repeat revascularization, and associated
cardiac events (stent thrombosis, myocardial infarction) remain significant clinical problem
in routine practice, especially complex lesion subsets.
2110 patients who received successful dug eluting stent implantation will be enrolled at 21
centers in Korea. Patients meeting inclusion criteria without any exclusion criteria and
agree to participate in this trial will be randomized 1: 1 to a) triple therapy
(Aspirin+Clopidogrel +Cilostazol) or b) dual therapy group (Aspirin+ Clopidogrel +Placebo).
All patients will be blindly assigned to cilostazol 100mg (1tablet bid) or matching placebo
(1tablet bid) as 1: 1 ratio and are prescribed for 1 year.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Clinical
1. Patients with angina and documented ischemia or patients with documented silent
ischemia
2. Patients who are eligible and has been successfully applied for DES implantation
3. Age >18 years
4. Signed written informed consent form prior to study entry
2. Angiographic
1. De novo lesion or restenotic lesions
2. Percent diameter stenosis ≥50%
3. Reference vessel size 2. 5 mm by visual estimation
Exclusion Criteria:
1. History of bleeding diathesis or coagulopathy (e. g. current use of NSAIDs, Upper GI
bleeding during the recent 6 months)
2. Pregnancy or lactation (women who have child-bearing potential)
3. Known hypersensitivity or contra-indication to contrast agent, heparin, eluted-drug
of stent
4. Limited life-expectancy (less than 1 year) due to combined serious disease
5. Characteristics of lesion 1)Left main disease 2)Graft vessels
6. Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3)
7. Hepatic dysfunction, liver enzyme (ALT and AST) elevation 3 times normal
8. Renal dysfunction, creatinine 2. 0mg/dL
9. Contraindication to aspirin, clopidogrel or cilostazol
10. Stroke (ischemic or hemorrhagic) or transient ischemic attack (TIA) within 6 months.
11. Planned major surgery within the next 6 months with the need to discontinue
antiplatelet therapy
Locations and Contacts
Sejong General Hospital, Bucheon, Korea, Republic of
Soonchunhyang Univ. Bucheon Hospital, Bucheon, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan, Cheonan, Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, Korea, Republic of
Chungnam National University Hospital, Daejeon, Korea, Republic of
The Catholic University of Korea, Daejeon ST. Mary's Hospital, Daejeon, Korea, Republic of
Gangneung Asan Hospital, Gangneung, Korea, Republic of
Pusan National University Yangsan Hospital, Pusan, Korea, Republic of
Department of Medicine, Asan Medical Center University of Ulsan College of Medicine, Seoul, Korea, Republic of
Gangnam Severance Hospital, Seoul, Korea, Republic of
SMA-SNU Boramae Medical Center, Seoul, Korea, Republic of
St.carollo Hospital, Suncheon, Korea, Republic of
Additional Information
Starting date: May 2011
Last updated: July 23, 2014
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