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

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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Cilostazol; Drug: Placebo

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
• Enrollment (Actual): 402
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Sejong General Hospital
  • Bucheon, Korea, Republic of
    • Soonchunhyang Univ. Bucheon Hospital
  • Cheonan, Korea, Republic of
    • Soon Chun Hyang University Hospital Cheonan
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Daejeon, Korea, Republic of
    • Chungnam national university hospital
  • Gangneung, Korea, Republic of
    • GangNeung Asan Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Yangsan Hospital
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • SMA-SNU Boramae Medical Center
  • Seoul, Korea, Republic of
    • Department of Medicine, Asan Medical Center University of Ulsan College of Medicine
  • Suncheon, Korea, Republic of
    • St.carollo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: cilostazol; cilostazol 100mg	Drug: Cilostazol; Cilostazol 100mg bid; Other Names: Pletaal
PLACEBO_COMPARATOR: dual therapy group; Placebo	Drug: Placebo; Placebo 1tablet bid

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac Events (MACE)	Composite of major cardiac adverse events (MACE) including death, Q-MI, Non Q- MI, and target lesion or vessel revascularization; Target vessel revascularization; Target lesion revascularization; Stent thrombosis (definite/probable); Ischemic stroke; Myocardial infarction; Adverse Events during study periods	At 1-year time point and yearly up to 3 years after PCI

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Investigators: Principal Investigator: Seung-Jung Park, MD, PhD, Department of Medicine, Asan Medical Center University of Ulsan College of Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: April 22, 2011
• First Submitted That Met QC Criteria: May 2, 2011
• First Posted (ESTIMATE): May 3, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 16, 2015
• Last Update Submitted That Met QC Criteria: November 13, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; DES; dual antiplatelet therapy; triple anti-platelet therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Neuroprotective Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Cilostazol
• Other Study ID Numbers: CVRF2010-10