BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial.
NCT01696110 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2194
Last updated 2014-10-01
Summary
The study would enrolled a total of 2100 AMI patients undergoing PCI to one of three antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor.
All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
Conditions
- Acute Myocardial Infarction
- Percutaneous Coronary Intervention
Interventions
- DRUG
-
Bivalirudin
Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
- DRUG
-
heparin
heparin monotherapy
- DRUG
-
heparin plus tirofiban
combined use of heparin and tirofiban during PCI
Sponsors & Collaborators
-
Shenyang Northern Hospital
lead OTHER
Principal Investigators
-
Yaling Han, MD · Shenyang Northern Hospital,China
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-08-31
- Primary Completion
- 2013-07-31
- Completion
- 2014-07-31
Countries
- China
Study Locations
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