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

Phase 4

• Conditions: Aged; STEMI; Percutaneous Coronary Intervention
• Interventions: Drug: Heparin; Drug: Bivalirudin

• Registration Number: NCT03882775
• Lead Sponsor: The First Affiliated Hospital of Dalian Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-16
• Status Verified: 2019-03
• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-19
• Last Update Submitted: 2019-03-19
• Study First Posted: 2019-03-20
• Last Update Posted: 2019-03-20
• Primary Completion: 2020-07-14
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heparin	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.
Bivalirudin	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.

Primary Outcome Measures

Name	Time	Method
Major bleeding	7 days	BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding
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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China