At a glance
ClinicalIndex Comparison Record- ✓Clinical symptoms of pulmonary embolism for less than 48 hours
- ✓Echocardiographic evidence of right ventricular dysfunction (submassive PE)
- ✓No indication for fibrinolytic therapy
- ✕PE symptoms present for more than 48 hours
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Drotrecogin Alfa (Activated) (LY203638)] Exploratory, Safety Study, Multi-Center, Randomized, Placebo-Controlled, Dose Escalating Study Design, Comparing a Standard Therapy (Enoxaparin Sodium) for Submassive Pulmonary Embolism to a Combined Therapy of Drotrecogin Alfa (Activated) Plus Enoxaparin Sodium.
In Brief
A Phase 2 clinical trial evaluating Drotrecogin Alfa (Activated), Enoxaparin, and 1 other intervention for Submassive Pulmonary Embolism. Completed, enrolled 47 participants across 1 site.
Detailed Summary
An exploratory, multicenter, randomized, placebo-controlled, double blind, dose escalation study comparing a standard therapy for submassive pulmonary embolism (Enoxaparin sodium) to a combined therapy of Drotrecogin alfa (activated) plus Enoxaparin sodium.
Study Details
Timeline
Interventions
6 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days
intravenous (IV), one infusion, over 12 hours
12 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
18 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
24 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours