Overview

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

Status:
Terminated

Trial end date:
2015-02-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Seung-Jung Park

Collaborator:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Treatments:

Cilostazol

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