Bivalirudin in Elderly Patients With Acute ST-segment Elevation Myocardial Infarction (BEST)

The First Affiliated Hospital of Dalian Medical University

Status and phase: Unknown; Phase 4

Conditions: Percutaneous Coronary Intervention; Aged; STEMI

Treatments: Drug: Bivalirudin; Drug: Heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT03882775

PJ-KY-2018-117

Details and patient eligibility

About

The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute ST-segment elevation myocardial infarction undergoing emergency PCI.

Enrollment: 240 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥75 years old;
• Planned emergency (Symptom onset within 24h) PCI for acute STEMI patients;
• Life expectancy ≥ 1 year;
• Provide written informed consent.

Exclusion criteria

• Contraindications to angiography or PCI;
• Active bleeding or bleeding constitution, bleeding tendency, including 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, intra-cerebral mass, aneurysm, etc.);
• Severe renal insufficiency (eGFR < 30 mL/min/ 1.73 m2);
• Elevated AST, ALT level higher than three times of the normal upper limit;
• Advanced heart failure (NYHA classification grading of cardiac function ≥ Ⅲ)
• Complicated with immune system diseases；
• Abnormal hematopoietic system：platelet count < 100 * 109 / L or > 700 * 109 / L，white blood cell count < 3 * 109/L etc;
• Suffering from acute infections ,infectious diseases or other serious diseases, such as malignant tumors;
• Known intolerance, or contraindication to any antithrombotic medication
• Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
• Non-cardiac co-morbid conditions are present that may result in protocol non-compliance;
• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
• Patient's inability to fully cooperate with the study protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Bivalirudin

Experimental group

Description:

Bivalirudin will be given as a bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterwards. Following this mandatory infusion,a reduced-dose infusion (0.2 mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of 0.3 mg/kg was given if the activated clotting time 5 minutes after the initial bolus was less than 225 seconds.

Treatment:

Drug: Bivalirudin

Heparin

Active Comparator group

Description:

Heparin will be administered at a dose of 70 to 100 units per kilogram in patients not receiving glycoprotein IIb/IIIa inhibitors and at a dose of 50 to 70 units per kilogram in patients receiving glycoprotein IIb/IIIa inhibitors. Subsequent adjustment of the heparin dose on the basis of the activated clotting time will be left to the discretion of the treating physicians.

Treatment:

Drug: Heparin