BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial.

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 2100 AMI patients undergoing percutaneous coronary intervention (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.

Official Title
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Bivalirudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin Undergoing Angioplasty (BRIGHT):a Randomised Controlled Trial

Conditions
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Acute Myocardial Infarction, Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Bivalirudin
* Drug: heparin
* Drug: heparin plus tirofiban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 80 years old Planned emergency PCI for acute myocardial infarction (STEMI or NSTEMI) Symptom onset within 12h for STEMI (or within 24 h for patients have unrelieved chest pain, continuous ST elevation or new developed LBBB) Symptom onset within 72h for NSTEMI Avoid to undergoing revascularization for non-culprit vessels within 30 days after index procedure. Provide written informed consent. Exclusion Criteria: Unsuitable for PCI; treatment by thrombolysis within 72 hours of acute ST-elevation myocardial infarction; left main coronary artery disease; cardiogenic shock. 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.; Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intracranial aneurysm, etc.), Deep puncture or major surgery (including eye or brain surgery) within 1 month. Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis. Untreated or uncontrolled hypertension > 180/110 mmHg. Hemoglobin < 100 g/L or platelet count < 100 * 109 / L. Elevated AST, ALT level higher than three times of the normal upper limit. severe renal insufficiency (eGFR < 30 mL/min / 1.73 m2). Heparin induced thrombocytopenia. Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution. Pregnancy or lactation. Researchers think that doesn't fit to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bivalirudin<br>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. | Drug: Bivalirudin<br>* Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.<br>* Other names: Taijianing;|
| Active Comparator: Heparin monotherapy<br>100 IU/kg intravenous bolus. If ACT <225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given. | Drug: heparin<br>* heparin monotherapy<br>|
| Active Comparator: heparin plus tirofiban<br>heparin 60 IU/kg intravenous bolus and Tirofiban: 10μg/kg intravenous bolus followed by 0.15μg/kg per min infusion for up to 36h. | Drug: heparin<br>* heparin monotherapy<br>Drug: heparin plus tirofiban<br>* combined use of heparin and tirofiban during PCI<br>* Other names: brand name of tirofiban: Xinweining;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net Adverse Clinical Events | 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 |
| --- | --- | --- |
| Net adverse clinical events | a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings | 1 year | 
| any bleedings (BARC class) | including all BARC class (class 1-5) | 30 day | 
| Major adverse cardiac and cerebral events (MACCE) | a composite of all cause death, reinfarction, target vessel revascularization or stroke | 30 days and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bivalirudin, Acute myocardial infarction, percutaneous transluminal coronary angioplasty