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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Cilostazol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. 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 2. Angiographic De novo lesion or restenotic lesions Percent diameter stenosis ≥50% Reference vessel size 2.5 mm by visual estimation Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cilostazol<br>cilostazol 100mg | Drug: Cilostazol<br>* Cilostazol 100mg bid<br>* Other names: Pletaal;|
| Placebo Comparator: dual therapy group<br>Placebo | Drug: Placebo<br>* Placebo 1tablet bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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triple anti-platelet therapy, dual antiplatelet therapy, DES, Coronary Artery Disease