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

Seung-Jung Park

Status and phase: Terminated; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Placebo; Drug: Cilostazol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01346865

CVRF2010-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 402 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical

2. Patients with angina and documented ischemia or patients with documented silent ischemia

3. Patients who are eligible and has been successfully applied for DES implantation

4. Age >18 years

5. Signed written informed consent form prior to study entry

6. Angiographic

7. De novo lesion or restenotic lesions

8. Percent diameter stenosis ≥50%

9. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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402 participants in 2 patient groups, including a placebo group

cilostazol

Experimental group

Description:

cilostazol 100mg

Treatment:

Drug: Cilostazol

dual therapy group

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo