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: 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 ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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

No publications provided

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
Health Authority: United States: Food and Drug Administration

Keywords provided by The Medicines Company:

Additional relevant MeSH terms:
Blood Platelet Disorders
Cardiovascular Diseases
Embolism and Thrombosis
Hematologic Diseases
Vascular Diseases
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses processed this record on February 04, 2016