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Randomized Comparison of Abciximab Plus Heparin With Bivalirudin in Acute Coronary Syndrome

NCT00373451 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1721

Last updated 2012-05-08

No results posted yet for this study

Summary

The purpose of this study is to determine which of these anti-clotting medications, abciximab plus unfractionated heparin or bivalirudin, is more effective to prevent thrombotic and bleeding complications in patients suffering from a heart attack and undergoing coronary intervention.

Conditions

Interventions

DRUG

Abciximab + UFH

Abciximab (0.25 mg/kg of body weight bolus, followed by a 0.125 µg/kg/minute \[maximum of 10 µg/minute\] infusion for 12 hours)

DRUG

Bivalirudin

Bivalirudin (intravenous bolus of 0.75 mg/kg prior to the start of the intervention, followed by infusion of 1.75 mg/kg per hour for the duration of the procedure)

DRUG

Heparin

i.v. bolus of 70 units/kg/body weight of unfractionated heparin

Sponsors & Collaborators

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Albert Schoemig, MD · Deutsches Herzzentrum Muenchen

  • Adnan Kastrati, MD · Deutsches Herzzentrum Muenchen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2011-05-31
Completion
2011-07-31

Countries

  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT00373451 on ClinicalTrials.gov