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

This study has been completed.
Information provided by (Responsible Party):
The Medicines Company Identifier:
First received: September 22, 2008
Last updated: November 8, 2011
Last verified: November 2011
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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Bivalirudin PCI Registry in HIT/HITTS Patients

Resource links provided by NLM:

Further study details as provided by The Medicines Company:

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

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00759083

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

Responsible Party: The Medicines Company Identifier: NCT00759083     History of Changes
Other Study ID Numbers: TMC-BIV-07-02
Study First Received: September 22, 2008
Last Updated: November 8, 2011

Keywords provided by The Medicines Company:

Additional relevant MeSH terms:
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Blood Platelet Disorders
Hematologic Diseases
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents processed this record on September 21, 2017