Bivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients

The Medicines Company

Status and phase: Withdrawn; Phase 4

Conditions: Heparin-Induced Thrombocytopenia; Heparin-induced Thrombocytopenia and Thrombosis Syndrome

Treatments: Drug: bivalirudin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00759083

TMC-BIV-07-02

Details and patient eligibility

About

To monitor the frequency of the development of thrombocytopenia in patients with Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome receiving bivalirudin during Percutaneous Coronary Intervention

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically Documented History of HIT/HITTS
• Suspicion of HIT/HITTS

Exclusion criteria

• Bleeding Diathesis
• Ischemic Stroke
• Chronic Thrombocytopenia
• Hematologic Malignancy
• Contraindication to bivalirudin
• Pregnant or nursing mothers

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

1

Experimental group

Description:

Patients with HIT/HITTS who require anticoagulation for PCI

Treatment:

Drug: bivalirudin