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

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ClinicalTrials.gov Identifier: NCT00759083
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : November 10, 2011
Sponsor:
Information provided by (Responsible Party):
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

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

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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
Actual Primary Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Bivalirudin

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




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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