- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02897037
Bivalirudin in Acute Myocardial Infarction
Bivalirudin vs Heparin During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Randomised Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Liaoning
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Shanyang, Liaoning, China, 110016
- Recruiting
- Department of Cardiology,General Hospital of Shenyang Military Region
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Contact:
- Zhenyang Liang, Dr.
- Phone Number: 86-13332457575
- Email: doctorliangzi@sina.com
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Contact:
- Yi Li
- Email: doctorliyi@126.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 to 80 years old
- 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)
- Provide written informed consent.
Exclusion Criteria:
- Age <18 or >80 years.
- Any anticoagulant drugs were regularly used within 3 months.
- Any anticoagulant agents were used 48 h before randomization.
- 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.
- Hemoglobin < 90 g/L or platelet count < 100 * 109 / L.
- Untreated or uncontrolled hypertension > 180/110 mmHg.
- Elevated ALT level higher than three times of the normal upper limit;severe renal insufficiency (eGFR < 30 mL/min / 1.73 m2).
- Heparin induced thrombocytopenia.
- Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis.
- Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
- Pregnancy , lactation or plan to be pregnant.
- Known serious progressive diseases such as malignant tumor or prognosis of the patients with severe failure;the survival time < 6 months.
- Unsuitable for PCI.
- Attended any clinical trial 1 month before randomised.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bivalirudin
Bivalirudin will be started in the cath lab, 0.75 mg/kg intravenous bolus followed by 1.75 mg/kg per h infusion; if ACT<225s 5min after bolus, an additional dose of 0.3mg/kg bolus should be given.
After procedure, a prolonged infusion (1.75mg/kg per h) will be given for at least 30 min (totally no more than 4 h) followed by a reduced dose infusion (0.2mg/kg per h) up to 20 h.
|
Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
Other Names:
|
Active Comparator: Heparin monotherapy
100 IU/kg intravenous bolus.
If ACT <225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given.
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heparin monotherapy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Net Adverse Clinical Events
Time Frame: 30 days
|
A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiac events (MACE)
Time Frame: 30 days
|
A composite of all cause death, reinfarction, target vessel revascularization or stroke
|
30 days
|
Any bleedings (BARC class)
Time Frame: 30 days
|
Including all BARC class (class 3-5)
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30 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Protease Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Heparin
- Bivalirudin
Other Study ID Numbers
- Bright2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Bivalirudin
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The Medicines CompanyCompleted
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Hamad Medical CorporationUnknownAnticoagulation in COVID-19 ARDSQatar
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The Medicines CompanyCompletedMyocardial InfarctionUnited States
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The Medicines CompanyCompletedThrombosis | Heparin-Induced ThrombocytopeniaUnited States