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

Sponsor

The First Affiliated Hospital of Dalian Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03882775

Collaborator

Beijing Friendship Hospital (Other)

240

Enrollment

Location

Arms

23.5

Anticipated Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
STEMI Percutaneous Coronary Intervention Aged	Drug: Bivalirudin Drug: Heparin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Bivalirudin vs Heparin in Elderly Patients With Acute ST-segment Elevation Myocardial Infarction Undergoing Emergency Percutaneous Coronary Intervention

Actual Study Start Date :

Jan 16, 2019

Anticipated Primary Completion Date :

Jul 14, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bivalirudin 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.	Drug: Bivalirudin Patients would be given anticoagulant therapy with bivalirudin in acute STEMI during emergency PCI operation.
Active Comparator: Heparin 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.	Drug: Heparin heparin with or without gpi during emergency PCI.

Arm

Intervention/Treatment

Experimental: Bivalirudin

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.

Drug: Bivalirudin

Patients would be given anticoagulant therapy with bivalirudin in acute STEMI during emergency PCI operation.

Active Comparator: Heparin

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.

Drug: Heparin

heparin with or without gpi during emergency PCI.

Outcome Measures

Primary Outcome Measures

Major adverse cardiac events [7 days]
a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina，Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Major bleeding [7 days]
BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding

Secondary Outcome Measures

Major adverse cardiac events [30 days]
a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina，Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Stent thrombosis ,TVR ,TLR [30 days]
rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation
Major adverse cardiac events [180 days]
a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina，Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Stent thrombosis ,TVR ,TLR [180 days]
rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts 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