At a glance
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Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During: a Multicenter, Randomized, Open-label Trial
In Brief
A clinical study evaluating Bivalirudin and unfractionated Heparin for ST Elevation Myocardial Infarction. Completed, enrolled 6,016 participants across 85 sites.
Detailed Summary
This study is aimed to investigate if the bivaliruding with prolonged full dose infusion after PCI is superior to heparin alone in reducing 30-day mortality or major bleeding for patients with STEMI treated with emergency PCI. A total of 6000 STEMI patients will be enrolled and randomly assigned to receive bivalirudin or heparin during emergency PCI in a 1:1 ratio. This study will provide key evidence for peri-operative anticoagulant therapy decisions in STEMI patients.
Study Details
Timeline
Interventions
Bivaliruding 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 2-4 hours after PCI. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is \<225 s (Hemotec method), intravenous injection of 0.35 mg/kg of bivalirudin should be administered, and the ACT re-checked to ensure it is \>225 seconds.
Heparin 70 U/kg is started before coronary angiography. ACT is monitored 5 min after the first administration, and if the ACT \<225 s (Hemotec method), an intravenous injection of 1000 U of heparin is administered, and the ACT re-checked to ensure it is \>225 seconds.