Status:
COMPLETED
Safety and Efficacy of Prolonged Use of Bivalirudin 4 Hours After ePCI (COBER Study)
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Since the development of percutaneous coronary intervention (PCI) in patients with coronary heart disease (CHD), unfractionated heparin (UFH) and low molecular weight heparin (LWMH) have been the pref...
Detailed Description
The current study is designed as a single-center, randomized and prospective study aiming to evaluate the safety and efficacy of prolonged continuous use of bivalirudin 4 hours after ePCI for the trea...
Eligibility Criteria
Inclusion
- De novo lesions
- elective PCI
- Only single coronary artery treated at this time
Exclusion
- Those who meet the diagnostic criteria of acute myocardial infarction
- Patients with cardio-genic shock
- Patients with multiple organ failure
- Patients allergic to contrast
- Patients who can not tolerate dual antiplatelet therapy
- Patients who can't tolerate anticoagulation
- Recently infected patients
- Patients with hepatorenal dysfunction
- Thrombotic lesion of coronary artery
- Chronic total coronary occlusion lesion
- Patients with complex coronary bifurcation requiring two stent strategy
- Severe coronary calcified lesion
- Patients with percutaneous coronary angioplasty
- Patients with directional coronary atherectomy or rotational atherectomy
- Patients with drug coated balloon treatment
- Patients with bioabsorbable vascular scaffold implantation
- Previous percutaneous coronary intervention
- Previous coronary artery bypass graft
- Patients with active stage of autoimmune disease
Key Trial Info
Start Date :
September 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT04120961
Start Date
September 20 2019
End Date
August 1 2022
Last Update
August 9 2022
Active Locations (1)
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1
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, China, 210006