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

Sponsor
Seung-Jung Park (Other)
Overall Status
Terminated
CT.gov ID
NCT01346865
Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
402
Enrollment
12
Locations
2
Arms
45.1
Duration (Months)
33.5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
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 1, 2011
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Major Adverse Cardiac and Cerebrovascular Ischemic Events (MACCE) [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) [At 1-year time point and yearly up to 3 years after PCI]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Clinical

    2. Patients with angina and documented ischemia or patients with documented silent ischemia

    3. Patients who are eligible and has been successfully applied for DES implantation

    4. Age >18 years

    5. Signed written informed consent form prior to study entry

    6. Angiographic

    7. De novo lesion or restenotic lesions

    8. Percent diameter stenosis ≥50%

    9. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sejong General Hospital Bucheon Korea, Republic of
    2 Soonchunhyang Univ. Bucheon Hospital Bucheon Korea, Republic of
    3 Soon Chun Hyang University Hospital Cheonan Cheonan Korea, Republic of
    4 Keimyung University Dongsan Medical Center Daegu Korea, Republic of
    5 Chungnam National University Hospital Daejeon Korea, Republic of
    6 The Catholic University of Korea, Daejeon ST. Mary's Hospital Daejeon Korea, Republic of
    7 Gangneung Asan Hospital Gangneung Korea, Republic of
    8 Pusan National University Yangsan Hospital Pusan Korea, Republic of
    9 Department of Medicine, Asan Medical Center University of Ulsan College of Medicine Seoul Korea, Republic of
    10 Gangnam Severance Hospital Seoul Korea, Republic of
    11 SMA-SNU Boramae Medical Center Seoul Korea, Republic of
    12 St.carollo Hospital Suncheon Korea, Republic of

    Sponsors and Collaborators

    • Seung-Jung Park
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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
    ClinicalTrials.gov Identifier:
    NCT01346865
    Other Study ID Numbers:
    • CVRF2010-10
    First Posted:
    May 3, 2011
    Last Update Posted:
    Nov 16, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Seung-Jung Park, M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine, CardioVascular Research Foundation, Korea
    triple anti-platelet therapy
    dual antiplatelet therapy
    DES
    Coronary Artery Disease
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Coronary Disease
    Cilostazol

    Study Results

    No Results Posted as of Nov 16, 2015