Angiomax in Patients With HIT/HITTS Type II Undergoing CPB

Phase 3

Completed

• Conditions: Cardiovascular Disease; Coronary Artery Bypass Surgery

• Registration Number: NCT00079508
• Lead Sponsor: The Medicines Company

Brief Summary

The purpose of this study is to demonstrate that in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) Type II undergoing cardiac surgery on cardiopulmonary bypass (CPB), Angiomax is a safe and effective anticoagulant.

Detailed Description

An open-label, prospective, multicenter, single-arm study; with a historical reference cohort of similarly identified HIT/HITTS patients from participating institutions that underwent cardiac surgery on CPB with alternative anticoagulation regimens during the period of approximately 12 months prior to initiation of the first patient into this study.

Study Timeline

• Study First Submitted: 2004-03-09
• Study First Submitted QC: 2004-03-10
• Study First Posted: 2004-03-11
• Study Start: 2004-04
• Primary Completion: 2005-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-08
• Last Update Posted: 2011-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Endpoint	7 days	In-hospital acute procedural success, defined as the absence of death, Q wave MI, repeat coronary revascularization, and stroke (hemorrhagic or ischemic) at hospital discharge or Day 7 after surgery ('Day 7/discharge'), whichever occurs first.

Trial Locations

Locations (1)

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States