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

This study is currently recruiting participants.

Verified by The Medicines Company, September 2008

Sponsored by:	The Medicines Company
Information provided by:	The Medicines Company
ClinicalTrials.gov Identifier:	NCT00759083

Purpose

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

Condition	Intervention	Phase
Heparin-Induced Thrombocytopenia Heparin-Induced Thrombocytopenia and Thrombosis Syndrome	Drug: bivalirudin	Phase IV

MedlinePlus related topics: Blood Thinners

Drug Information available for: Heparin Bivalirudin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Bivalirudin PCI Registry in HIT/HITTS Patients

Further study details as provided by The Medicines Company:

Primary Outcome Measures:

Platelet counts [ Time Frame: 6, 12, 24, 48 Hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	September 2008
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients with HIT/HITTS who require anticoagulation for PCI	Drug: bivalirudin Bivalirudin; 0.75mg/kg/h IV bolus followed immediately by 1.75 mg/kg/h infusion for the duration of the procedure

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759083

Contacts

Contact: Dana Montgomery

973-641-6025

dana.montgomery@themedco.com

Locations

United States, North Carolina
Duke Clinical Research Institute	Recruiting
Durham, North Carolina, United States, 27705
Contact: Manesh Patel, MD 919-668-7807

Sponsors and Collaborators

The Medicines Company

Investigators

Principal Investigator:

Magnus Ohman, MD

Duke University

More Information

Responsible Party:	The Medicines Company ( Meredith Todd, Director Clinical Operations )
Study ID Numbers:	TMC-BIV-07-02
Study First Received:	September 22, 2008
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00759083
Health Authority:	United States: Food and Drug Administration

Keywords provided by The Medicines Company:

HIT
HITTS

Study placed in the following topic categories:

Thrombocytopathy
Embolism and Thrombosis
Thrombocytopenia
Heparin-induced thrombocytopenia
Embolism
Hematologic Diseases

Bivalirudin
Blood Platelet Disorders
Vascular Diseases
Heparin
Thrombosis
Calcium heparin

Additional relevant MeSH terms:

Anticoagulants
Pathologic Processes
Disease
Therapeutic Uses

Syndrome
Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009