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

Phase 4

Withdrawn

• Conditions: Heparin-Induced Thrombocytopenia; Heparin-induced Thrombocytopenia and Thrombosis Syndrome
• Interventions: Drug: bivalirudin

• Registration Number: NCT00759083
• Lead Sponsor: The Medicines Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-23
• Study First Posted: 2008-09-25
• Primary Completion: 2009-09
• Study Completion: 2010-05-10
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	bivalirudin	Patients with HIT/HITTS who require anticoagulation for PCI

Primary Outcome Measures

Name	Time	Method
Platelet counts	6, 12, 24, 48 Hours

Trial Locations

Locations (1)

Duke Clinical Research Institute; 🇺🇸 Durham, North Carolina, United States