Clinical trial NCT01346865: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: triple anti-platelet therapy
dual antiplatelet therapy
DES
Coronary Artery Disease
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: Otsuka Pharmaceutical Development & Commercialization, Inc.
First posted: 2011-05-03
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular Ischemic Events (MACCE)
timeFrame: At 1-year time point after PCI
Secondary outcomes:
measure: Major Adverse Cardiac Events (MACE)
timeFrame: At 1-year time point and yearly up to 3 years after PCI
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Sejong General Hospital
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang Univ. Bucheon Hospital
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST. Mary's Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Medicine, Asan Medical Center University of Ulsan College of Medicine
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: SMA-SNU Boramae Medical Center
city: Suncheon
country: Korea, Republic of
facility: St.carollo Hospital
Study officials:
affiliation: Department of Medicine, Asan Medical Center University of Ulsan College of Medicine
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: