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

Phase 4TerminatedNCT01346865

Seung-Jung Park402 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

402

Conditions

Coronary Artery Disease

Interventions

CilostazolDRUG

Cilostazol 100mg bid

PlaceboDRUG

Placebo 1tablet bid

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (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

Outcomes

Primary Outcomes

Major Adverse Cardiac and Cerebrovascular Ischemic Events (MACCE)

composite of any death, myocardial infarction, ischemic stroke, target vessel revascularization

Time frame: At 1-year time point after PCI

Secondary Outcomes

Major Adverse Cardiac Events (MACE)

1. Composite of major cardiac adverse events (MACE) including death, Q-MI, Non Q- MI, and target lesion or vessel revascularization 2. Target vessel revascularization 3. Target lesion revascularization 4. Stent thrombosis (definite/probable) 5. Ischemic stroke 6. Myocardial infarction 7. Adverse Events during study periods

Time frame: At 1-year time point and yearly up to 3 years after PCI

Data from ClinicalTrials.gov

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