Back to resultsBivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients
Primary Purpose
Heparin-Induced Thrombocytopenia, Heparin-induced Thrombocytopenia and Thrombosis Syndrome
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bivalirudin
Sponsored by
About this trial
This is an interventional prevention trial for Heparin-Induced Thrombocytopenia focused on measuring HIT, HITTS
Eligibility 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
Sites / Locations
- Duke Clinical Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Patients with HIT/HITTS who require anticoagulation for PCI
Outcomes
Primary Outcome Measures
Platelet counts
Secondary Outcome Measures
Full Information
NCT ID
NCT00759083
First Posted
September 22, 2008
Last Updated
October 15, 2020
Sponsor
The Medicines Company
1. Study Identification
Unique Protocol Identification Number
NCT00759083
Brief Title
Bivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients
Official Title
Bivalirudin PCI Registry in HIT/HITTS Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The study was discontinued early due to inadequate patient enrollment. No patients were enrolled.
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
May 10, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Medicines Company
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heparin-Induced Thrombocytopenia, Heparin-induced Thrombocytopenia and Thrombosis Syndrome
Keywords
HIT, HITTS
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients with HIT/HITTS who require anticoagulation for PCI
Intervention Type
Drug
Intervention Name(s)
bivalirudin
Intervention Description
Bivalirudin; 0.75mg/kg/h IV bolus followed immediately by 1.75 mg/kg/h infusion for the duration of the procedure
Primary Outcome Measure Information:
Title
Platelet counts
Time Frame
6, 12, 24, 48 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Ohman, MD
Organizational Affiliation
Duke Clinical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Clinical Research Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients
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