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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01346865
• Other study ID #: CVRF2010-10
• Status: Terminated
• Phase: Phase 4
• First received: April 22, 2011
• Last updated: November 13, 2015
• Start date: May 2011
• Est. completion date: February 2015

Study information

• Verified date: November 2015
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 402
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Cilostazol
Cilostazol 100mg bid
• Placebo
Placebo 1tablet bid

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	At 1-year time point and yearly up to 3 years after PCI	Yes