Phase 2
N=47
Adjuvant Treatment of Pulmonary Embolism With Drotrecogin Alfa (Activated): Phase II Exploratory Study
Submassive Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT00191724 ↗Enrolled (actual)
47
Serious AEs
—
Results posted
Jun 2009
Primary outcome: Primary: Number of Participants With Major Bleeding Events — 1; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Drotrecogin Alfa (Activated) (Drug); Enoxaparin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Bleeding Events |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios |
0.8; 1.0; 1.0; 0.9; 1.1; 0.7 | 0.528 |
| SECONDARY Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) |
5.0; 4.5; 4.8; 5.0; 4.8; 4.8 | 0.018 sig |
| SECONDARY Difference in Pulmonary Artery (PA) Pressure |
— | — |
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.
Eligibility Criteria
Patients with symptoms of acute pulmonary embolism (PE), without an indication for fibrinolytic therapy but with echocardiographic evidence of right ventricular dysfunction (submassive PE) within 48 hours of onset of symptoms
Inclusion Criteria
- Clinical symptoms of Pulmonary embolism for less than 48 hours
Exclusion Criteria
- Patients with symptoms of Pulmonary embolism for more than 48 hours
Data sourced from ClinicalTrials.gov (NCT00191724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.