NCT01349777

Effectiveness of Clopidogrel Resinate in PCI(PRIDE)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,056 (actual)
• Sponsor: Seung-Jung Park · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Pregrel®	Pregrel® 75mg daily for 12 months
DRUG	Plavix®	Plavix® 75mg daily for 12 months

Timeline

• Start date: 2010-03-15
• Primary completion: 2017-03-14
• Completion: 2017-03-14
• First posted: 2011-05-09
• Last updated: 2017-06-16

Locations

3 sites across 1 country: South Korea