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Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB

NCT00073593 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2011-11-10

No results posted yet for this study

Summary

The purpose of this study is to examine the safety and efficacy of Angiomax as an alternative anticoagulant to heparin with protamine reversal in patients undergoing off-pump coronary artery bypass graft surgery.

Conditions

  • Cardiac Surgery
  • Coronary Artery Bypass Surgery

Interventions

DRUG

Bivalirudin

250 mg vial administered as 0.75 mg/kg intravenous (IV) bolus and 1.75 mg/kg/h IV infusion for the duration of surgery with the option to increase or decrease the infusion in 0.25 mg/kg/h increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an activated clotting time (ACT) \>300 seconds (s).

DRUG

Heparin

: Per institutional practice, at 1.5-3.5 mg/kg (200-400 U/kg) IV bolus to achieve a target ACT of \>300 s followed by weight-adjusted boluses as needed during surgery to achieve/maintain the target ACT. Batches from hospital stock.

DRUG

Protamine

Per institutional practice. Batches from hospital stock.

Sponsors & Collaborators

  • The Medicines Company

    lead INDUSTRY

Principal Investigators

  • Andrew Sternlicht, MD · The Medicines Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2004-05-31

Countries

  • United States

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 NCT00073593 on ClinicalTrials.gov