Adjuvant Treatment of Pulmonary Embolism With Drotrecogin Alfa (Activated): Phase II Exploratory Study

Phase 2

Completed

• Conditions: Submassive Pulmonary Embolism
• Interventions: Drug: Enoxaparin; Drug: Placebo; Drug: Drotrecogin Alfa (Activated)

• Registration Number: NCT00191724
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-01-14
• Results First Submitted QC: 2009-04-28
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-16
• Results First Posted: 2009-06-17
• Last Update Posted: 2009-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5	Enoxaparin	-
5	Placebo	-
1	Enoxaparin	-
2	Enoxaparin	-
3	Enoxaparin	-
4	Enoxaparin	-
4	Drotrecogin Alfa (Activated)	-
1	Drotrecogin Alfa (Activated)	-
2	Drotrecogin Alfa (Activated)	-
3	Drotrecogin Alfa (Activated)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Major Bleeding Events	baseline through day 6	Number of patients with major bleeding events, defined as: Reduction in hemoglobin of 2 to 5 grams per deciliter (g/dL) within 24 hours; Transfusion of 2 to 4 units of packed red blood cells within 24 hours; Hematoma requiring prolonged hospitalization or surgical intervention; Intracranial or retroperitoneal hemorrhage.

Secondary Outcome Measures

Name	Time	Method
Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios	baseline, day 6, day 90	Change of right ventricular function measured as difference of right ventricular enddiastolic area/left ventricular enddiastolic area (RVEDA/LVEDA) ratios by echocardiography
Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada)	baseline and day 90 (follow-up)	Scores in each of the 4 domains (dyspnea, fatigue, emotional, and mastery) ranged from 1 (maximum impairment) to 7 (no impairment).
Difference in Pulmonary Artery (PA) Pressure	baseline, day 6, day 90	Investigator decided estimate of pulmonary artery pressure by echocardiography would not be useful and no data on pulmonary artery pressure were collected.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇩🇪 Mannheim, Germany