DRUG
Bivalirudin
Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
Status
Unknown
Phase
Phase 3
Enrollment
380
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES. This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone. All enrolled patients would be followed-up to 30 days.
Full detailed description
This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone. All enrolled patients would be followed-up to 30 days. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
Interventions
Treatment arms and agents.
DRUG
heparin
heparin monotherapy
Timeline
From registration to results.
First posted
Sep 12, 2016
Study start
Nov 2016
Primary completion
Jun 2017
Study completion
Dec 2017
Results posted
Not reported
Registry updated
Nov 28, 2016
Outcomes
What the study measures.
Primary outcomes
Net Adverse Clinical Events
Time frame · 30 days
A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings
Secondary outcomes
Major adverse cardiac events (MACE)
Time frame · 30 days
A composite of all cause death, reinfarction, target vessel revascularization or stroke
Any bleedings (BARC class)
Time frame · 30 days
Including all BARC class (class 3-5)
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Age 18 to 80 years old 2. Planned emergency PCI for acute myocardial infarction (STEMI) Symptom onset within 12h for STEMI (or within 12-24 hrs for patients have unrelieved chest pain, continuous ST elevation or new developed LBBB) 3. Provide written informed consent. Exclusion Criteria: 1. Age \<18 or \>80 years. 2. Any anticoagulant drugs were regularly used within 3 months. 3. Any anticoagulant agents were used 48 h before randomization. 4. Active bleeding or bleeding constitution, bleeding tendency, including the recent retina or vitreous hemorrhage (1 months), GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc. 5. Hemoglobin \< 90 g/L or platelet count \< 100 \* 109 / L. 6. Untreated or uncontrolled hypertension \> 180/110 mmHg. 7. Elevated ALT level higher than three times of the normal upper limit;severe renal insufficiency (eGFR \< 30 mL/min / 1.73 m2). 8. Heparin induced thrombocytopenia. 9. Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis. 10. Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution. 11. Pregnancy , lactation or plan to be pregnant. 12. Known serious progressive diseases such as malignant tumor or prognosis of the patients with severe failure;the survival time \< 6 months. 13. Unsuitable for PCI. 14. Attended any clinical trial 1 month before randomised.
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Department of Cardiology，General Hospital of Shenyang Military Region
Shanyang, Liaoning, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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