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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.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00759083
First received: September 22, 2008
Last updated: November 8, 2011
Last verified: November 2011
History of Changes
  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 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:

MedlinePlus related topics: Blood Thinners
Drug Information available for: Bivalirudin
U.S. FDA Resources

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

  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

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

No publications provided

Responsible Party: The Medicines Company
ClinicalTrials.gov 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:
HIT
HITTS

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

ClinicalTrials.gov processed this record on May 22, 2013