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

Shenyang Northern Hospital

Status and phase: Completed; Phase 4

Conditions: Percutaneous Coronary Intervention; Acute Myocardial Infarction

Treatments: Drug: heparin plus tirofiban; Drug: heparin; Drug: Bivalirudin

Study type: Interventional

Funder types: Other

Identifiers

NCT01696110

SYNH20120001

2011BAI11B07 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,194 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 to 80 years old
2. 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
3. Avoid to undergoing revascularization for non-culprit vessels within 30 days after index procedure.
4. Provide written informed consent.

Exclusion criteria

1. Unsuitable for PCI; treatment by thrombolysis within 72 hours of acute ST-elevation myocardial infarction; left main coronary artery disease; cardiogenic shock.
2. Any anticoagulant agents were used 48 h before randomization.
3. 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.;
4. Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intracranial aneurysm, etc.),
5. Deep puncture or major surgery (including eye or brain surgery) within 1 month.
6. Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis.
7. Untreated or uncontrolled hypertension > 180/110 mmHg.
8. Hemoglobin < 100 g/L or platelet count < 100 * 109 / L.
9. Elevated AST, ALT level higher than three times of the normal upper limit.
10. severe renal insufficiency (eGFR < 30 mL/min / 1.73 m2).
11. Heparin induced thrombocytopenia.
12. Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
13. Pregnancy or lactation.
14. Researchers think that doesn't fit to participate in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,194 participants in 3 patient groups

Bivalirudin

Experimental group

Description:

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.

Treatment:

Drug: Bivalirudin

Heparin monotherapy

Active Comparator group

Description:

100 IU/kg intravenous bolus. If ACT \<225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given.

Treatment:

Drug: heparin

heparin plus tirofiban

Active Comparator group

Description:

heparin 60 IU/kg intravenous bolus and Tirofiban: 10μg/kg intravenous bolus followed by 0.15μg/kg per min infusion for up to 36h.

Treatment:

Drug: heparin

Drug: heparin plus tirofiban