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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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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