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Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

NCT04046029 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2019-08-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Beijing Friendship Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Dalian Medical University

    lead OTHER

Principal Investigators

  • Shaoke Meng, M.D. · The First Affiliated Hospital of Dalian Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-08
Primary Completion
2020-07-30
Completion
2021-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04046029 on ClinicalTrials.gov