Clinical trial NCT01349777: Effectiveness of Clopidogrel Resinate in PCI(PRIDE)
Official title: Effectiveness of Clopidogrel Resinate(PRegrel®) in Patients Undergoing Percutaneous Coronary Intervention Compared With ClopiDogrEl Bisulfate(Plavix®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: antiplatelet therapy post drug eluting stents
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2011-05-09
Enrollment: 1056
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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®).

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: composite of death (all cause-mortality), MI (Q wave and non Q wave) and stroke
timeFrame: 12 months
Secondary outcomes:
measure: composite of death, MI, stroke, or urgent revascularization
timeFrame: 12 months
measure: Individual components of death, MI, stroke, or urgent revascularization
timeFrame: at discharge
measure: The need for target vessel revascularization or any revascularization
timeFrame: 12 months
measure: The incidence of early discontinuation of study drugs
timeFrame: 30 days
measure: The incidence of major bleeding events
timeFrame: 30 days
measure: Stent thrombosis
timeFrame: 30 days
measure: composite of death, MI, stroke, or urgent revascularization
timeFrame: 30 days
measure: composite of death, MI, stroke, or urgent revascularization
timeFrame: 6 months
measure: Individual components of death, MI, stroke, or urgent revascularization
timeFrame: 30 days
measure: Individual components of death, MI, stroke, or urgent revascularization
timeFrame: 6 months
measure: Individual components of death, MI, stroke, or urgent revascularization
timeFrame: 12 months
measure: The incidence of major bleeding events
timeFrame: 6 months
measure: The incidence of major bleeding events
timeFrame: 12 months
measure: The incidence of early discontinuation of study drugs
timeFrame: 6 months
measure: The incidence of early discontinuation of study drugs
timeFrame: 12 months
measure: Stent thrombosis
timeFrame: 6 months
measure: Stent thrombosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: