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NCT00759083 Clinical Trial

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

Heparin-Induced Thrombocytopenia Clinical Trial

Official title:
Bivalirudin PCI Registry in HIT/HITTS Patients

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00759083
Other study ID # TMC-BIV-07-02
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date September 2008
Est. completion date May 10, 2010

Study information
Verified date October 2020
Source The Medicines Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 10, 2010
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• bivalirudin
Bivalirudin; 0.75mg/kg/h IV bolus followed immediately by 1.75 mg/kg/h infusion for the duration of the procedure

Locations
Country Name City State
United States Duke Clinical Research Institute Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
The Medicines Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Platelet counts 6, 12, 24, 48 Hours
See also
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