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

• Sponsor: The Medicines Company (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT00759083
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Duration (Months): 20.2
• Patients Per Site Per Month: 0

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Heparin-Induced Thrombocytopenia; Heparin-induced Thrombocytopenia and Thrombosis Syndrome	Drug: bivalirudin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Bivalirudin PCI Registry in HIT/HITTS Patients
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: May 10, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Platelet counts [6, 12, 24, 48 Hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Medicines Company
• ClinicalTrials.gov Identifier: NCT00759083
• Other Study ID Numbers: TMC-BIV-07-02
• First Posted: Sep 25, 2008
• Last Update Posted: Oct 19, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by The Medicines Company: HIT; HITTS
• Additional relevant MeSH terms: Thrombosis; Thrombocytopenia; Syndrome; Bivalirudin

Study Results

No Results Posted as of Oct 19, 2020