CompletedPhase 3

Angiomax in Patients With HIT/HITTS Type II Undergoing CPB

United States125 participantsStarted 2004-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Positive heparin-induced platelet aggregation (HIPA) or other functional assay for HIT or immunoassay for HIT antibodies (ELISA), AND/OR
✓. HIT: Thrombocytopenia associated with heparin therapy, where the platelet count has decreased by 50%\*, OR
✓. HITTS: Thrombocytopenia (as defined in B above) PLUS any evidence of arterial or venous thrombosis

What they're measuring

Primary Endpoint

Timeframe: 7 days

Trial details

NCT IDNCT00079508

SponsorThe Medicines Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-10

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