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Bivalirudin in Late PCI for Oatients With STEMI

NCT04185077 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2019-12-10

No results posted yet for this study

Summary

Bivalirudin is recomended by guidelines during primary PCI procedure for patients with STEMI. However, there is a large number of STEMI patients who missed the primary PCI. So the investigators aim to study the efficiency and safety of bivalirudin as the anticoagulation therapy during late PCI.

Conditions

  • STEMI - ST Elevation Myocardial Infarction

Interventions

DRUG

Bivalirudin

Bivalirudin (Salubris Pharmaceuticals Co) was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/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 (0.2mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of0.3mg/kgwasgivenif the activatedclotting time 5minutes after the initial bolus (measuredwith the Hemotec assay) was less than 225 seconds.

DRUG

Heparin

a bolus dose of 100 U/kg was administered according to current guidelines.Additional heparinwasadministered if the post-bolus activated clotting time was less than 225 seconds.

Sponsors & Collaborators

  • Second Xiangya Hospital of Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-30
Primary Completion
2020-12-31
Completion
2020-12-31

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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 NCT04185077 on ClinicalTrials.gov