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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00759083
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : November 10, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Heparin-Induced Thrombocytopenia Heparin-induced Thrombocytopenia and Thrombosis Syndrome Drug: bivalirudin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Bivalirudin PCI Registry in HIT/HITTS Patients
Study Start Date : September 2008
Primary Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Bivalirudin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
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


Outcome Measures

Primary Outcome Measures :
  1. Platelet counts [ Time Frame: 6, 12, 24, 48 Hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759083


Locations
United States, North Carolina
Duke Clinical Research Institute
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
The Medicines Company
Investigators
Principal Investigator: Magnus Ohman, MD Duke Clinical Research Institute
More Information

Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00759083     History of Changes
Other Study ID Numbers: TMC-BIV-07-02
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: November 10, 2011
Last Verified: November 2011

Keywords provided by The Medicines Company:
HIT
HITTS

Additional relevant MeSH terms:
Syndrome
Thrombosis
Thrombocytopenia
Disease
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Blood Platelet Disorders
Hematologic Diseases
Bivalirudin
Hirudins
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents