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

NCT ID: NCT00759083

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-05-10

Brief Summary

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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

Detailed Description

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Conditions

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Heparin-Induced Thrombocytopenia Heparin-induced Thrombocytopenia and Thrombosis Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Patients with HIT/HITTS who require anticoagulation for PCI

Group Type EXPERIMENTAL

bivalirudin

Intervention Type DRUG

Bivalirudin; 0.75mg/kg/h IV bolus followed immediately by 1.75 mg/kg/h infusion for the duration of the procedure

Interventions

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bivalirudin

Bivalirudin; 0.75mg/kg/h IV bolus followed immediately by 1.75 mg/kg/h infusion for the duration of the procedure

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Medicines Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Magnus Ohman, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Locations

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Duke Clinical Research Institute

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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TMC-BIV-07-02

Identifier Type: -

Identifier Source: org_study_id

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