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

This study is ongoing, but not recruiting participants.
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: July 23, 2014
Last verified: July 2014
  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:


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


Enrollment: 402
Study Start Date: May 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346865

Locations
Korea, Republic of
Soonchunhyang Univ. Bucheon Hospital
Bucheon, Korea, Republic of
Sejong General Hospital
Bucheon, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
Cheonan, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
Gangneung Asan Hospital
Gangneung, Korea, Republic of
Pusan National University Yangsan Hospital
Pusan, 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
Seoul, Korea, Republic of
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
  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: July 23, 2014
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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Cilostazol
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Respiratory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014