Drug-Eluting Stenting Followed by Cilostazol tREAtment Reduces SErious Adverse Cardiac Events (DECREASE-PCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01346865
Recruitment Status : Terminated (Low Recruitment)
First Posted : May 3, 2011
Last Update Posted : November 16, 2015
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Cilostazol Drug: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2011
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Cilostazol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: cilostazol
cilostazol 100mg
Drug: Cilostazol
Cilostazol 100mg bid
Other Name: Pletaal
Placebo Comparator: dual therapy group
Drug: Placebo
Placebo 1tablet bid

Primary Outcome Measures :
  1. Major Adverse Cardiac and Cerebrovascular Ischemic Events (MACCE) [ Time Frame: At 1-year time point after PCI ]
    composite of any death, myocardial infarction, ischemic stroke, target vessel revascularization

Secondary Outcome Measures :
  1. Major Adverse Cardiac Events (MACE) [ Time Frame: At 1-year time point and yearly up to 3 years after PCI ]
    1. Composite of major cardiac adverse events (MACE) including death, Q-MI, Non Q- MI, and target lesion or vessel revascularization
    2. Target vessel revascularization
    3. Target lesion revascularization
    4. Stent thrombosis (definite/probable)
    5. Ischemic stroke
    6. Myocardial infarction
    7. Adverse Events during study periods

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01346865

Korea, Republic of
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
Sponsors and Collaborators
Seung-Jung Park
Otsuka Pharmaceutical Development & Commercialization, Inc.
Principal Investigator: Seung-Jung Park, MD, PhD Department of Medicine, Asan Medical Center University of Ulsan College of Medicine

Responsible Party: Seung-Jung Park, M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine, CardioVascular Research Foundation, Korea Identifier: NCT01346865     History of Changes
Other Study ID Numbers: CVRF2010-10
First Posted: May 3, 2011    Key Record Dates
Last Update Posted: November 16, 2015
Last Verified: November 2015

Keywords provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:
triple anti-platelet therapy
dual antiplatelet therapy
Coronary Artery Disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors