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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
47
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
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
Number of Participants With Major Bleeding Events
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.
Time frame: baseline through day 6
Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios
Change of right ventricular function measured as difference of right ventricular enddiastolic area/left ventricular enddiastolic area (RVEDA/LVEDA) ratios by echocardiography
Time frame: baseline, day 6, day 90
Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada)
Scores in each of the 4 domains (dyspnea, fatigue, emotional, and mastery) ranged from 1 (maximum impairment) to 7 (no impairment).
Time frame: baseline and day 90 (follow-up)
Difference in Pulmonary Artery (PA) Pressure
Investigator decided estimate of pulmonary artery pressure by echocardiography would not be useful and no data on pulmonary artery pressure were collected.
Time frame: baseline, day 6, day 90
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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