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Activated Protein C in Acute Stroke Trial (APCAST)

This study has been terminated.
(Lack of recruitment)
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Curtis Benesch, University of Rochester
ClinicalTrials.gov Identifier:
NCT00533546
First received: September 19, 2007
Last updated: September 1, 2016
Last verified: September 2016
Results First Received: October 16, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stroke
Intervention: Drug: Activated Protein C

  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
The recruitment period spanned the following dates: October 2007 through July 2010. Location of recruitment and enrollment was in the emergency department of approved sites for patients presenting with acute ischemic stroke. Of the 9 participating sites, 3 actively enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No patients were excluded after enrollment.

Reporting Groups
  Description
Intravenous APC 10 Microgram/kg Dose

Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.

Activated Protein C : Intravenous APC (10 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset


Participant Flow:   Overall Study
    Intravenous APC 10 Microgram/kg Dose
STARTED   12 
COMPLETED   12 
NOT COMPLETED   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.
No text entered.

Reporting Groups
  Description
Intravenous APC 10 Microgram/kg Dose

Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.

Activated Protein C : Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset


Baseline Measures
   Intravenous APC 10 Microgram/kg Dose 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.6  (17.3) 
Gender 
[Units: Participants]
 
Female   5 
Male   7 
Region of Enrollment 
[Units: Participants]
 
United States   12 


  Outcome Measures
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1.  Primary:   Number of Participants With Intracranial Hemorrhage   [ Time Frame: Measured within 36-48 hours of treatment ]

2.  Secondary:   Mean Modified Rankin Scale Score   [ Time Frame: 90 days ]

3.  Secondary:   Mean Barthel Index Score   [ Time Frame: 90 days ]

4.  Secondary:   National Institutes of Health Stroke Scale (NIHSS)   [ Time Frame: 90 days ]


  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
Study was terminated after completion of Tier One dosing level (n=12 subjects) due to lack of recruitment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Curtis Benesch, M.D., M.P.H.
Organization: University of Rochester
phone: 585 275-2530
e-mail: curtis_benesch@urmc.rochester.edu



Responsible Party: Curtis Benesch, University of Rochester
ClinicalTrials.gov Identifier: NCT00533546     History of Changes
Other Study ID Numbers: 537
5R01HL080107 ( US NIH Grant/Contract Award Number )
5R01HL080107-05 ( US NIH Grant/Contract Award Number )
Study First Received: September 19, 2007
Results First Received: October 16, 2015
Last Updated: September 1, 2016