NCT04046029

Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

Bivalirudin vs Heparin in Elderly Patients With Acute Coronary Syndrome Undergoing Elective Percutaneous Coronary Intervention

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: The First Affiliated Hospital of Dalian Medical University · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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 coronary syndrome undergoing elective percutaneous coronary intervention.

Conditions

• Acute Coronary Syndrome
• Percutaneous Coronary Intervention
• Aging
• Anticoagulants and Bleeding Disorders

Interventions

Type	Name	Description
DRUG	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	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.

Timeline

• Start date: 2019-07-08
• Primary completion: 2020-07-30
• Completion: 2021-06-30
• First posted: 2019-08-06
• Last updated: 2019-08-06

Locations

1 site across 1 country: China