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

Bivalirudin PCI Registry in HIT/HITTS Patients

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00759083
Enrollment
0
Registered
2008-09-25
Start date
2008-09-30
Completion date
2010-05-10
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heparin-Induced Thrombocytopenia, Heparin-induced Thrombocytopenia and Thrombosis Syndrome

Keywords

HIT, HITTS

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

Interventions

DRUGbivalirudin

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

Sponsors

The Medicines Company
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Platelet counts6, 12, 24, 48 Hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026