Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-FDR) (CLEAR-FDR)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Arthur Pancioli, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01977456
First received: October 18, 2013
Last updated: December 16, 2015
Last verified: October 2015
Results First Received: October 23, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Stroke
Brain Infarction
Intervention: Drug: Eptifibatide

  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
No text entered.

Reporting Groups
  Description
Eptifibatide

All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.

Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.


Participant Flow:   Overall Study
    Eptifibatide  
STARTED     27  
COMPLETED     22  
NOT COMPLETED     5  
Death                 5  



  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
Eptifibatide

All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.

Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.


Baseline Measures
    Eptifibatide  
Number of Participants  
[units: participants]
  27  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     6  
>=65 years     21  
Age  
[units: years]
Mean (Standard Deviation)
  70.4  (12.9)  
Gender  
[units: participants]
 
Female     14  
Male     13  
Region of Enrollment  
[units: participants]
 
United States     27  
National Institutes of Health Stroke Scale Score (NIHSS) [1]
[units: score]
Median (Inter-Quartile Range)
  12  
  (9 to 16)  
[1] NIHSS score: A 43 point ordinal scale (0 to 42) measuring severity of stroke. 0 (no measurable effect), 42 (dead)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Number of Patients Who Experience Symptomatic Intracerebral Hemorrhage (sICH).   [ Time Frame: within 36 hours after stroke onset ]

2.  Secondary:   The Number of Patients Who Experience Any Intracerebral Hemorrhage (ICH).   [ Time Frame: within 36 hours after stroke onset ]

3.  Secondary:   The Number of Patients Who Develop Parenchymal Hemorrhage Types 1( PH-1) and 2 (PH-2).   [ Time Frame: within 36 hours after stroke onset ]

4.  Other Pre-specified:   The Number of Participants With Good Outcomes According to the Modified Rankin Score.   [ Time Frame: 90 days from the date of stroke onset ]


  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
Small sample size and open design. Did not include endovascular therapy patients.


  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: Dr. Opeolu Adeoye
Organization: University of Cincinnati
phone: 513-558-3117
e-mail: opeolu.adeoye@uc.edu


Publications of Results:

Responsible Party: Arthur Pancioli, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01977456     History of Changes
Other Study ID Numbers: P50NS044283-13
P50NS044283-13 ( Other Grant/Funding Number: NINDS )
Study First Received: October 18, 2013
Results First Received: October 23, 2015
Last Updated: December 16, 2015
Health Authority: United States: Food and Drug Administration