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

NCT ID: NCT01346865

Last Updated: 2015-11-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 402 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-02-28

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

cilostazol

cilostazol 100mg

Group Type: EXPERIMENTAL

Cilostazol

Intervention Type: DRUG

Cilostazol 100mg bid

dual therapy group

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 1tablet bid

Interventions

Cilostazol

Cilostazol 100mg bid

Intervention Type: DRUG

Placebo

Placebo 1tablet bid

Intervention Type: DRUG

Other Intervention Names

Pletaal

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: collaborator

Seung-Jung Park

OTHER

Sponsor Role: lead

Responsible Party

Seung-Jung Park

M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Seung-Jung Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Asan Medical Center University of Ulsan College of Medicine

Locations

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

Countries

South Korea

Other Identifiers

CVRF2010-10

Identifier Type: -

Identifier Source: org_study_id