Comparison One vs Six Months of Dual Antiplatelet Therapy After Implanted Firehawk TM Stent in High Bleeding Risk Patients With Coronary Artery Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 1580
Summary
- Conditions
- Coronary Disease
- Drug Eluting Stent
- Dual Antiplatelet Therapy
- Percutaneous Coronary Intervention
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a prospective, double -blind,multi-center,randomized controlled trial. Approximately 1,720 subjects in high bleeding risk with coronary artery disease will be enrolled in no more than 40 research centers in China. All participants met the inclusion criteria will be 1:1 randomized to 1 month ...
This is a prospective, double -blind,multi-center,randomized controlled trial. Approximately 1,720 subjects in high bleeding risk with coronary artery disease will be enrolled in no more than 40 research centers in China. All participants met the inclusion criteria will be 1:1 randomized to 1 month or 6months of DAPT after implanting Firehawk™ coronary stent. Clinical follow-up will be carried out at 30 days, 6 months, 12 months, 2 years after index procedure.The primary study endpoint is Net Adverse Clinical and Cerebral Events (NACCE), a composite of all-cause death, myocardial infarction (MI), cerebral vascular accident (CVA) and major bleeding ([BARC] definition) at 12 months. Subjects that complete of 12 months follow-up will be regarded as having completed the primary endpoint. The secondary study endpoints contain cost-effectiveness at 12 months, ARC defined stent thrombosis (ST) ; NACCE ;major adverse cardiovascular events (MACE),major adverse cardiovascular and cerebral events (MACCE),target lesion revascularization (TLR),target vessel failure(TVF) , major bleeding at 30 days,6,12 and 24 months of follow-up.
Tracking Information
- NCT #
- NCT03287167
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Yaling Han, MD The General Hospital of Shenyang Military