Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00043940 · ClinicalTrials.gov registry record · Phase 3
Anticoagulant Therapy With Bivalirudin in the Performance of Percutaneous Coronary Intervention in Patients With Heparin-Induced Thrombocytopenia (AT BAT, First Inning)
A Phase 3 study of Thrombosis and Heparin-induced Thrombocytopenia, sponsored by The Medicines Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT00043940 is a Phase 3 study of Thrombosis and Heparin-induced Thrombocytopenia that has completed, run by The Medicines Company. The registered enrollment target is 50 participants, below the 468-participant average among 28 other Thrombosis trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00043940, a Phase 3 study of Thrombosis and Heparin-induced Thrombocytopenia, has completed, sponsored by The Medicines Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective: To assess the safety of bivalirudin as an alternative anticoagulant therapy for patients with new or previous heparin-induced thrombocytopenia (HIT) / heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing percutaneous coronary intervention (PCI). This will be measured by the composite incidence of major bleeding events during administration or within 48 hours after stopping bivalirudin (or at hospital discharge, whichever occurs first). The components of the composite endpoint are: a) intracranial bleeding; b) retroperitoneal bleeding; c) bleeding that results in hemodynamic compromise; d) bleeding that requires transfusion of three or more units of whole blood or packed red cells; and e) a decrease in hemoglobin of greater than or equal to g/dL or in hematocrit of greater than or equal to 9%. Secondary Objectives: Each component of the primary composite endpoint. To evaluate the level of anticoagulation achieved with bivalirudin. The goal is to achieve an activated clotting time (ACT) between 300 and 350 sec during PCI and 4-hour bivalirudin infusion. To evaluate bivalirudin's effects on platelet counts.
Conditions Studied
Interventions
- DRUG bivalirudin
Study Locations (1)
North Carolina
- Duke Clinical Research Institute, Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 1999-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00043940
The ClinicalTrials.gov registry entry for NCT00043940 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 468-participant average among 28 other Thrombosis trials with a reported enrollment target (89% lower). The listed sponsor is The Medicines Company, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Thrombosis appearing as the primary indexed condition, and to 1 intervention - of which bivalirudin is the first listed.
NCT00043940 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT00043940 about?
NCT00043940 is a clinical study titled "Anticoagulant Therapy With Bivalirudin in the Performance of Percutaneous Coronary Intervention in Patients With Heparin-Induced Thrombocytopenia (AT BAT, First Inning)". Primary Objective: To assess the safety of bivalirudin as an alternative anticoagulant therapy for patients with new or previous heparin-induced thrombocytopenia (HIT) / heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing percutaneous coronary intervention (PCI). This will b...
What is the current status of trial NCT00043940?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 1999-04.
What conditions does trial NCT00043940 study?
This clinical trial studies the following conditions: Thrombosis, Heparin-induced Thrombocytopenia.
What interventions are being tested in trial NCT00043940?
The interventions under investigation include: bivalirudin (DRUG).
Who is sponsoring clinical trial NCT00043940?
This trial is sponsored by The Medicines Company, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00043940 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Thrombosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters
COMPLETED · Phase 3
-
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
RECRUITING
-
Positron Emission Tomography (PET) Imaging of Thrombosis
RECRUITING · Phase 1
-
Pharmacogenomics of Warfarin in Hispanics and Latinos
RECRUITING
-
Neonatal Platelet Transfusion Threshold Trial
RECRUITING · NA
-
Vascular Lab Resource (VLR) Biorepository
RECRUITING
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.