search
Back to results

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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cilostazol
Placebo
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring triple anti-platelet therapy, dual antiplatelet therapy, DES, Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

cilostazol

dual therapy group

Arm Description

cilostazol 100mg

Placebo

Outcomes

Primary Outcome Measures

Major Adverse Cardiac and Cerebrovascular Ischemic Events (MACCE)
composite of any death, myocardial infarction, ischemic stroke, target vessel revascularization

Secondary Outcome Measures

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

Full Information

First Posted
April 22, 2011
Last Updated
November 13, 2015
Sponsor
Seung-Jung Park
Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01346865
Brief Title
Drug-Eluting Stenting Followed by Cilostazol tREAtment Reduces SErious Adverse Cardiac Events (DECREASE-PCI)
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 Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Low Recruitment
Study Start Date
May 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
triple anti-platelet therapy, dual antiplatelet therapy, DES, Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cilostazol
Arm Type
Experimental
Arm Description
cilostazol 100mg
Arm Title
dual therapy group
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Other Intervention Name(s)
Pletaal
Intervention Description
Cilostazol 100mg bid
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 1tablet bid
Primary Outcome Measure Information:
Title
Major Adverse Cardiac and Cerebrovascular Ischemic Events (MACCE)
Description
composite of any death, myocardial infarction, ischemic stroke, target vessel revascularization
Time Frame
At 1-year time point after PCI
Secondary Outcome Measure Information:
Title
Major Adverse Cardiac Events (MACE)
Description
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
Time Frame
At 1-year time point and yearly up to 3 years after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Clinical Patients with angina and documented ischemia or patients with documented silent ischemia Patients who are eligible and has been successfully applied for DES implantation Age >18 years Signed written informed consent form prior to study entry 2. Angiographic De novo lesion or restenotic lesions Percent diameter stenosis ≥50% Reference vessel size 2.5 mm by visual estimation Exclusion Criteria: History of bleeding diathesis or coagulopathy (e.g. current use of NSAIDs, Upper GI bleeding during the recent 6 months) Pregnancy or lactation (women who have child-bearing potential) Known hypersensitivity or contra-indication to contrast agent, heparin, eluted-drug of stent Limited life-expectancy (less than 1 year) due to combined serious disease Characteristics of lesion 1)Left main disease 2)Graft vessels Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3) Hepatic dysfunction, liver enzyme (ALT and AST) elevation 3 times normal Renal dysfunction, creatinine 2.0mg/dL Contraindication to aspirin, clopidogrel or cilostazol Stroke (ischemic or hemorrhagic) or transient ischemic attack (TIA) within 6 months. Planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Jung Park, MD, PhD
Organizational Affiliation
Department of Medicine, Asan Medical Center University of Ulsan College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sejong General Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Soonchunhyang Univ. Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Cheonan
City
Cheonan
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Daejeon ST. Mary's Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Gangneung Asan Hospital
City
Gangneung
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Department of Medicine, Asan Medical Center University of Ulsan College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
SMA-SNU Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
St.carollo Hospital
City
Suncheon
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs