Effectiveness of Clopidogrel Resinate in PCI(PRIDE)

Coronary Artery Disease Clinical Trial

Official title:

Effectiveness of Clopidogrel Resinate(PRegrel®) in Patients Undergoing Percutaneous Coronary Intervention Compared With ClopiDogrEl Bisulfate(Plavix®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349777
• Other study ID #: 2009-0483
• Status: Completed
• Phase: Phase 4
• First received: April 22, 2011
• Last updated: June 15, 2017
• Start date: March 15, 2010
• Est. completion date: March 14, 2017

Study information

• Verified date: June 2017
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1056
• Est. completion date: March 14, 2017
• Est. primary completion date: March 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Pregrel®
Pregrel® 75mg daily for 12 months
• Plavix®
Plavix® 75mg daily for 12 months

Locations

Country	Name	City	State
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite of death (all cause-mortality), MI (Q wave and non Q wave) and stroke		12 months
Secondary	composite of death, MI, stroke, or urgent revascularization		12 months
Secondary	Individual components of death, MI, stroke, or urgent revascularization		at discharge
Secondary	The need for target vessel revascularization or any revascularization		12 months
Secondary	The incidence of early discontinuation of study drugs		30 days
Secondary	The incidence of major bleeding events		30 days
Secondary	Stent thrombosis		30 days
Secondary	composite of death, MI, stroke, or urgent revascularization		30 days
Secondary	composite of death, MI, stroke, or urgent revascularization		6 months
Secondary	Individual components of death, MI, stroke, or urgent revascularization		30 days
Secondary	Individual components of death, MI, stroke, or urgent revascularization		6 months
Secondary	Individual components of death, MI, stroke, or urgent revascularization		12 months
Secondary	The incidence of major bleeding events		6 months
Secondary	The incidence of major bleeding events		12 months
Secondary	The incidence of early discontinuation of study drugs		6 months
Secondary	The incidence of early discontinuation of study drugs		12 months
Secondary	Stent thrombosis		6 months
Secondary	Stent thrombosis		12 months