Effectiveness of Clopidogrel Resinate in PCI(PRIDE)

Seung-Jung Park

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: Plavix®

Drug: Pregrel®

Study type

Interventional

Funder types

Other

Identifiers

NCT01349777

2009-0483

Details and patient eligibility

About

This study is an open label, multi-center, randomized trial, which is designed to evaluate the efficacy and safety of clopidogrel derivative (Pregrel®) therapy for 12 months in patients undergoing PCI compared to conventional clopidogrel (Plavix®).

Full description

Prospective, two arms, randomized multi-center trial of 1,056 patients enrolled at 3 centers in Korea.

Following angiography, patients with significant diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Pregrel® group vs. b) Plavix®. This trial is the non-inferiority study to demonstrate that the incidence of 12 months primary end-point in Pregrel® group.

Enrollment

1,056 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient must be at least 18 years of age.
Patients with symptomatic coronary artery disease with objective evidence of ischemia (e.g. symptoms of angina pectoris, positive stress test results, or dynamic ECG changes).
Patients are referred for PCI, or thought to be at high likelihood for requiring stent placement with or without conventional balloon angioplasty
The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion criteria

The patient has a known hypersensitivity or contraindication to any of the following medications:
- Heparin
- Aspirin
- Both Clopidogrel and Ticlopidine
- Stainless steel and/or
- Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenylhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
Coronary anatomy not amenable to stent placement
Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
An elective major surgical procedure is planned that would necessitate interruption of thienopyridines during the first 1 year post enrollment.
Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Administration of the following medications prior to randomization: GpIIb-IIIa inhibitor and clopidogrel within 7 days (already received pretreatment), or thrombolytics within 24 hours.
Long-term (at least > 3 months) use or requirement of NSAID or anticoagulation
Patients with cardiogenic shock
Acute MI patients within symptom onset < 12 hours needing primary angioplasty
Patients with left main stem stenosis (>50% by visual estimate)