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
Results First Received: January 14, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Submassive Pulmonary Embolism
Interventions: Drug: Drotrecogin Alfa (Activated)
Drug: Enoxaparin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Drotrecogin Alfa (Activated) - 6 Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
Drotrecogin Alfa (Activated) - 12 Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
Drotrecogin Alfa (Activated) - 18 Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
Drotrecogin Alfa (Activated) - 24 Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
Placebo Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days

Participant Flow:   Overall Study
    Drotrecogin Alfa (Activated) - 6     Drotrecogin Alfa (Activated) - 12     Drotrecogin Alfa (Activated) - 18     Drotrecogin Alfa (Activated) - 24     Placebo  
STARTED     6     9     9     8     15  
COMPLETED     5     8     8     5     12  
NOT COMPLETED     1     1     1     3     3  
Adverse Event                 0                 0                 1                 0                 0  
Lost to Follow-up                 1                 1                 0                 2                 3  
Withdrawal by Subject                 0                 0                 0                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Drotrecogin Alfa (Activated) - 6 Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
Drotrecogin Alfa (Activated) - 12 Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
Drotrecogin Alfa (Activated) - 18 Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
Drotrecogin Alfa (Activated) - 24 Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
Placebo Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
Total Total of all reporting groups

Baseline Measures
    Drotrecogin Alfa (Activated) - 6     Drotrecogin Alfa (Activated) - 12     Drotrecogin Alfa (Activated) - 18     Drotrecogin Alfa (Activated) - 24     Placebo     Total  
Number of Participants  
[units: participants]
  6     9     9     8     15     47  
Age  
[units: years]
Mean ± Standard Deviation
  70.8  ± 4.4     65.7  ± 8.9     51.9  ± 16.5     45.6  ± 22.6     60.7  ± 21.9     58.7  ± 18.9  
Gender  
[units: participants]
           
Female     3     3     5     3     11     25  
Male     3     6     4     5     4     22  
Region of Enrollment  
[units: participants]
           
Germany     6     9     9     8     15     47  
Medical History - Acute Coronary Syndrome/Myocardial Infarction  
[units: participants]
           
Acute Coronary Syndrome/MI - Yes     0     1     0     0     0     1  
Acute Coronary Syndrome/MI - No     6     8     9     8     13     44  
Acute Coronary Syndrome/MI - Unknown     0     0     0     0     2     2  
Medical History - Chronic Obstructive Pulmonary Disease  
[units: participants]
           
Chronic Obstructive Pulmonary Disease - Yes     0     2     0     0     0     2  
Chronic Obstructive Pulmonary Disease - No     5     7     9     8     13     42  
Chronic Obstructive Pulmonary Disease - Unknown     1     0     0     0     2     3  
Medical History - Deep Vein Thrombosis  
[units: participants]
           
Deep Vein Thrombosis - Yes     1     2     1     2     2     8  
Deep Vein Thrombosis - No     2     7     8     6     13     36  
Deep Vein Thrombosis - Unknown     3     0     0     0     0     3  
Medical History - Ischemic Stroke  
[units: participants]
           
Ischemic Stroke - Yes     1     1     0     0     3     5  
Ischemic Stroke - No     4     8     9     8     12     41  
Ischemic Stroke - Unknown     1     0     0     0     0     1  
Medical History - Pulmonary Embolism  
[units: participants]
           
Pulmonary Embolism - Yes     1     2     0     1     0     4  
Pulmonary Embolism - No     3     7     9     7     15     41  
Pulmonary Embolism - Unknown     2     0     0     0     0     2  
Medical History - Venous Thromboembolism  
[units: participants]
           
Venous Thromboembolism - Yes     0     2     1     0     1     4  
Venous Thromboembolism - No     3     7     8     7     12     37  
Venous Thromboembolism - Unknown     3     0     0     1     2     6  
Race/Ethnicity  
[units: participants]
           
Caucasian     6     9     8     7     15     45  
Other     0     0     0     1     0     1  
Unknown     0     0     1     0     0     1  
Body Weight  
[units: kilograms]
Mean ± Standard Deviation
  76.0  ± 9.7     93.9  ± 13.3     85.2  ± 17.6     86.4  ± 13.8     85.7  ± 18.6     86.0  ± 16.0  



  Outcome Measures
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1.  Primary:   Number of Participants With Major Bleeding Events   [ Time Frame: baseline through day 6 ]

2.  Secondary:   Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios   [ Time Frame: baseline, day 6, day 90 ]

3.  Secondary:   Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada)   [ Time Frame: baseline and day 90 (follow-up) ]

4.  Secondary:   Difference in Pulmonary Artery (PA) Pressure   [ Time Frame: baseline, day 6, day 90 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was stopped early after 47 patients had been enrolled (planned enrollment was 48 patients). Study was stopped early due to slow enrollment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-545-5979


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191724     History of Changes
Other Study ID Numbers: 8354, F1K-MC-O014
Study First Received: September 12, 2005
Results First Received: January 14, 2009
Last Updated: June 16, 2009
Health Authority: Germany: Paul-Ehrlich-Institut