Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Unfractionated heparin · 1 trial · 1 indication
Change in the end-diastolic RV/LV ratio from baseline to 24 hours by echocardiography.
Bleeding will be classified as major if it is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g., intracranial, intraspinal). To aid in evaluating the relationship of bleeding events to rt-PA administration, they will also be categorized by whether they occurred within 3 days after the initiation of thrombolytic therapy.
| Arm | Type | Description |
|---|---|---|
| Ultrasound accelerated thrombolysis | EXPERIMENTAL | Patients in this arm will receive anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System will be used to deliver a low dose \<20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus. |
| Intravenous unfractionated heparin | ACTIVE_COMPARATOR | Patients in this arm will receive the standard of care: intravenous unfractionated heparin used as anti-coagulation treatment. |
| Name | Type | Description |
|---|---|---|
| EkoSonic Endovascular System | DEVICE | The EkoSonic Endovascular System will be used to deliver \< 20 mg of rt-PA ( Actilyse) directly into the occlusive pulmonary thrombus. |
| Unfractionated heparin | DRUG | Intravenous unfractionated heparin used for anticoagulation treatment |
Inclusion Criteria: * Patients with acute PE symptoms \< 14 days. * Filling defect by contrast-enhanced chest CT in at least one main or proximal lower lobe pulmonary artery * Right ventricular dysfunction confirmed by echocardiography where the RV/LV end diastolic diameter ratio is ≥ 1.0. Exclusi...
Unfractionated heparin is being studied for use in submassive pulmonary embolism, a condition where blood clots travel to the lungs. It is part of a Phase 3 clinical trial evaluating treatment approaches for this condition. The drug is administered as part of a therapeutic strategy to manage clot resolution in patients with this diagnosis.
Unfractionated heparin targets coagulation factors in the blood, specifically enhancing the activity of antithrombin III to inhibit thrombin and factor Xa. This mechanism prevents the formation of blood clots and is relevant in the treatment of submassive pulmonary embolism, where clot resolution is critical.
Boston Scientific Corporation, traded as BSX on the stock exchange, is developing unfractionated heparin for submassive pulmonary embolism. The company is conducting a Phase 3 clinical trial to evaluate its use in this indication.
Unfractionated heparin is in Phase 3 clinical development for submassive pulmonary embolism. It is an investigational drug in this context, meaning it has not yet been approved for this use. The Phase 3 trial has been completed, with results expected to inform further regulatory decisions.
Unfractionated heparin is associated with one completed Phase 3 clinical trial, NCT01166997, titled 'ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism'. This randomized, active-controlled trial enrolled 59 participants with submassive pulmonary embolism across Germany and Switzerland.
Unfractionated heparin is a form of heparin, but it is distinct from low molecular weight heparins. In the context of this clinical development, it is being evaluated specifically for submassive pulmonary embolism. The drug is also known simply as heparin, though unfractionated heparin refers to the standard formulation.