A Phase 3 interventional study of bivalirudin in Heparin-Induced Thrombocytopenia and Thrombosis, sponsored by The Medicines Company. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-16.
Sponsored by The Medicines Company · Phase 3, Interventional, and Treatment
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.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's enrollment of 50 is below the median of 106 across 849 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →The Medicines Company is the lead sponsor of 48 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
(A) Positive heparin-induced platelet aggregation (HIPA) or other functional assay, defined as: (B) HIT: Thrombocytopenia associated with heparin therapy, where the platelet count: (i) has decreased to \<100x10(9)/L (minimum of 30% drop from the platelet count before heparin treatment), OR (ii) has decreased to \<150x10(9)/L (minimum of 40% drop from the platelet count before heparin treatment, OR, (C) HITTS: Thrombocytopenia (as defined above) PLUS arterial or venous thrombosis (deep-vein thrombosis, pulmonary embolism, mesenteric venous or arterial thrombosis, acute myocardial infarction, left ventricular thrombus, ischemic stroke, or occlusion or limb arteries), diagnosed by physical exam/lab evidence and/or appropriate imaging studies (duplex ultrasound, venography, ventilation-perfusion scan, venous or arterial angiography, MRI/MRA, catheterization).
EXCLUSION:
Bivalirudin therapy will be given as a 0.75-mg/kg intravenous bolus and 1.75-mg/kg/h intravenous infusion during procedure and up to 4 hours.
Major bleeding events
composite incidence of major bleeding events during administration or within 48 hours after stopping bivalirudin
Time frame: 48 hours
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Medicines Company