Study Stopped
Low Recruitment
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
1 other identifier
interventional
402
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 coronary-artery-disease
Started May 2011
Typical duration for phase_4 coronary-artery-disease
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedFirst Posted
Study publicly available on registry
May 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedNovember 16, 2015
November 1, 2015
3.8 years
April 22, 2011
November 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Major Adverse Cardiac Events (MACE)
At 1-year time point and yearly up to 3 years after PCI
Study Arms (2)
cilostazol
EXPERIMENTALcilostazol 100mg
dual therapy group
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- \. 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
- \. Angiographic
- De novo lesion or restenotic lesions
- Percent diameter stenosis ≥50%
- Reference vessel size 2.5 mm by visual estimation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Sejong General Hospital
Bucheon-si, South Korea
Soonchunhyang Univ. Bucheon Hospital
Bucheon-si, South Korea
Soon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Pusan National University Yangsan Hospital
Pusan, South Korea
Department of Medicine, Asan Medical Center University of Ulsan College of Medicine
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
SMA-SNU Boramae Medical Center
Seoul, South Korea
St.carollo Hospital
Suncheon, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jung Park, MD, PhD
Department of Medicine, Asan Medical Center University of Ulsan College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine
Study Record Dates
First Submitted
April 22, 2011
First Posted
May 3, 2011
Study Start
May 1, 2011
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
November 16, 2015
Record last verified: 2015-11