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

This study is currently recruiting participants.
Verified August 2012 by CardioVascular Research Foundation, Korea
Sponsor:
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01346865
First received: April 22, 2011
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
 Drug: Cilostazol
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

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

Further study details as provided by CardioVascular Research Foundation, Korea:

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


Secondary Outcome Measures:
  • Major Adverse Cardiac Events (MACE) [ Time Frame: At 1-year time point and yearly up to 3 years after PCI ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 2110
Study Start Date: May 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cilostazol
cilostazol 100mg
 Drug: Cilostazol
Cilostazol 100mg bid
Other Name: Pletaal
Placebo Comparator: dual therapy group
Placebo
 Drug: Placebo
Placebo 1tablet bid
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346865

Contacts
Contact: Seung-Jung Park, MD, PhD. (82-2)-3010-3152 sjpark@amc.seoul.kr

Locations
Korea, Republic of
Department of Medicine, Asan Medical Center University of Ulsan College of Medicine Recruiting
Seoul, Korea, Republic of
Contact: Seung-Jung Park, MD, PhD.     (82-2)-3010-3152     sjpark@amc.seoul.kr    
Principal Investigator: Seung-Jung Park, MD, PhD            
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
  More Information

No publications 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     History of Changes
Other Study ID Numbers: CVRF2010-10
Study First Received: April 22, 2011
Last Updated: August 7, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by 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
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cilostazol
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
 Hematologic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 16, 2013