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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191724
First received: September 12, 2005
Last updated: June 16, 2009
Last verified: June 2009
History of Changes

September 12, 2005
June 16, 2009
September 2004
January 2008   (final data collection date for primary outcome measure)
Number of Participants With Major Bleeding Events [ Time Frame: baseline through day 6 ] [ Designated as safety issue: Yes ]
To assess the rate of major bleeding events in the combined treatment of Drotrecogin alfa(activated) with low molecular weight heparin versus low molecular weight heparin alone in treatment of acute submassive PE
Complete list of historical versions of study NCT00191724 on ClinicalTrials.gov Archive Site
  • Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios [ Time Frame: baseline, day 6, day 90 ] [ Designated as safety issue: Yes ]
  • Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) [ Time Frame: baseline and day 90 (follow-up) ] [ Designated as safety issue: No ]
  • Difference in Pulmonary Artery (PA) Pressure [ Time Frame: baseline, day 6, day 90 ] [ Designated as safety issue: Yes ]
  • -Change of right ventricular function measured as difference of RVED/LVED ratios between baseline and day 6+/-1 and day 90+/-7, as measured by echocardiography
  • -Quality of Life as measured by Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada)
Not Provided
Not Provided
 
Adjuvant Treatment of Pulmonary Embolism With Drotrecogin Alfa (Activated): Phase II Exploratory Study
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.

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Submassive Pulmonary Embolism
  • Drug: Drotrecogin Alfa (Activated)
    6 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
    Other Name: Xigris, LY203638
  • Drug: Enoxaparin
    1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days
  • Drug: Placebo
    intravenous (IV), one infusion, over 12 hours
  • Drug: Drotrecogin Alfa (Activated)
    12 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
    Other Name: Xigris, LY203638
  • Drug: Drotrecogin Alfa (Activated)
    18 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
    Other Name: Xigris, LY203638
  • Drug: Drotrecogin Alfa (Activated)
    24 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
    Other Name: Xigris, LY203638
  • Experimental: 1
    Interventions:
    • Drug: Drotrecogin Alfa (Activated)
    • Drug: Enoxaparin
  • Experimental: 2
    Interventions:
    • Drug: Enoxaparin
    • Drug: Drotrecogin Alfa (Activated)
  • Experimental: 3
    Interventions:
    • Drug: Enoxaparin
    • Drug: Drotrecogin Alfa (Activated)
  • Experimental: 4
    Interventions:
    • Drug: Enoxaparin
    • Drug: Drotrecogin Alfa (Activated)
  • Placebo Comparator: 5
    Interventions:
    • Drug: Enoxaparin
    • Drug: Placebo
Dempfle CE, Elmas E, Link A, Suvajac N, Liebe V, Janes J, Borggrefe M. Endogenous plasma activated protein C levels and the effect of enoxaparin and drotrecogin alfa (activated) on markers of coagulation activation and fibrinolysis in pulmonary embolism. Crit Care. 2011;15(1):R23. Epub 2011 Jan 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00191724
8354, F1K-MC-O014
Yes
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP