Safety and Efficacy of Delayed Continuous Use of Bivalirudin 4 Hours After ePCI (COBER Study)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coronary Heart Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 100 years
- Gender
- Both males and females
Description
The current study is designed as a single-center, randomized and prospective study aiming to evaluate the safety and efficacy of delayed continuous use of bivalirudin 4 hours after ePCI for the treatment of peri-operative myocardial injury (PMI) compared with bivalirudin use during ePCI. Based on pr...
The current study is designed as a single-center, randomized and prospective study aiming to evaluate the safety and efficacy of delayed continuous use of bivalirudin 4 hours after ePCI for the treatment of peri-operative myocardial injury (PMI) compared with bivalirudin use during ePCI. Based on previous study reported and estimated 10% loss follow-up of these patients in each arm, a total of 330 patients with CHD were required in our study, and with 165 patients per group as a ratio of 1:1 randomization.
Tracking Information
- NCT #
- NCT04120961
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Zhiming Wu, MD Nanjing First Hospital, Nanjing Medical University
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