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Reduce Bolus Injection of Bivalirudin

NCT03588611 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2021-08-09

No results posted yet for this study

Summary

There are fewer studies on the bleeding risk of the currently administered bivalirudin bolus injection dose and the safety of bivalirudin in patients with CKD. A non-inferiority, randomized, stratified controlled trial study has been conducted to evaluate the non-inferiority and safety of the low dose (80%) bolus injections of bivalirudin in patients with or without CKD.This study will provide a safe, effective and economical anticoagulation strategy.

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

Bivalirudin

0.75mg/kg+ 1.75 mg/kg▪h for the duration of PCI;

DRUG

Bivalirudin

0.6mg/kg+ 1.75 mg/kg▪h for the duration of PCI;

Sponsors & Collaborators

  • Han Yaling, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2021-06-26
Completion
2021-06-26

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 NCT03588611 on ClinicalTrials.gov