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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Arthur Pancioli, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00894803
First received: May 6, 2009
Last updated: March 26, 2014
Last verified: March 2014
Results First Received: November 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Ischemic Stroke
Stroke
Brain Infarction
Interventions: Drug: Eptifibatide
Drug: rt-PA

  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 trial was conducted in emergency departments at 9 US medical centers comprised of 21 hospitals. Subjects were recruited between July 2009 and October 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No enrolled participants were excluded from the trial before assignment to groups.

Reporting Groups
  Description
Rt-PA and Eptifibatide recombinant tissue Plasminogen Activator (rt-PA; 0.6 mg/kg) and Epifibatide (225 mcg/kg)
Rt-PA Only recombinant tissue Plasminogen Activator (rt-PA; 0.9 mg/kg)

Participant Flow:   Overall Study
    Rt-PA and Eptifibatide     Rt-PA Only  
STARTED     101     25  
COMPLETED     81     20  
NOT COMPLETED     20     5  
Death                 20                 4  
Lost to Follow-up                 0                 1  



  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
Rt-PA Only rt-PA (0.9 mg/kg)
Rt-PA and Eptifibatide rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
Total Total of all reporting groups

Baseline Measures
    Rt-PA Only     Rt-PA and Eptifibatide     Total  
Number of Participants  
[units: participants]
  25     101     126  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     7     37     44  
>=65 years     18     64     82  
Age  
[units: years]
Mean ± Standard Deviation
  70.9  ± 13.0     69.0  ± 13.6     69.3  ± 13.4  
Age  
[units: Years]
Median ( Inter-Quartile Range )
  75.5  
  ( 60.5 to 81.4 )  
  71.6  
  ( 58.1 to 81.5 )  
  74.2  
  ( 58.1 to 81.5 )  
Gender  
[units: participants]
     
Female     12     48     60  
Male     13     53     66  
Region of Enrollment  
[units: participants]
     
United States     25     101     126  
National Institutes of Health Stroke Scale Score (NIHSS) [1]
[units: Participants]
     
NIHSS <=12     10     56     66  
NIHSS >12     15     45     60  
National Institutes of Health Stroke Scale Score (NIHSS) [1]
[units: units on a scale]
Mean ± Standard Deviation
  16.4  ± 6.7     14.1  ± 6.9     14.6  ± 6.9  
National Institutes of Health Stroke Scale Score (NIHSS) [1]
[units: units on a scale]
Median ( Inter-Quartile Range )
  17  
  ( 11 to 22 )  
  12  
  ( 9 to 20 )  
  12  
  ( 9 to 20 )  
Stroke symptom onset to intravenous rt-PA start [2]
[units: Participants]
     
< 1 hour     0     1     1  
1 to 2 hours     11     56     67  
>2 to 3 hours     13     42     55  
> 3 hours     1     2     3  
Stroke symptom onset to intravenous rt-PA start [3]
[units: minutes]
Median ( Inter-Quartile Range )
  129  
  ( 90 to 141 )  
  113  
  ( 99 to 135 )  
  116  
  ( 97 to 138 )  
Modified Rankin Score (mRS) [4]
[units: participants]
     
0     16     74     90  
1     2     11     13  
2     3     7     10  
3     4     4     8  
4     0     5     5  
5     0     0     0  
[1] National Institutes of Health Stroke Scale Score (NIHSS), 43 point ordinal scale (0 to 42), measuring severity of stroke. 0 (no measurable effect), 42 (dead).
[2] Time from stroke symptom onset to intravenous rt-PA start
[3] Tme from stroke symptom onset to intravenous rt-PA start
[4] modified Rankin Score (mRS), 6 point ordinal scale, measuring functional status. 0 (no symptoms at all), 5 (severe disability; bedridden, incontinent, and requiring constant nursing care)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours of Treatment Onset   [ Time Frame: Within 36 hours of initiation of therapy ]

2.  Primary:   Modified Rankin Scale (mRS) Score <1 or Return to mRS Baseline   [ Time Frame: 90 days from treatment onset ]

3.  Secondary:   Barthel Index ≥ 95   [ Time Frame: 90 days from treatment onset ]

4.  Secondary:   Glasgow Outcome Scale (GOS) of 1   [ Time Frame: 90 days from treatment onset ]

5.  Other Pre-specified:   Serious Systemic Bleeding   [ Time Frame: Within 7 days of treatment onset ]

6.  Other Pre-specified:   Symptomatic Intracranial Hemorrhage (sICH) Within 7 Days of Treatment Onset   [ Time Frame: Within 7 days of treatment onset ]

7.  Other Pre-specified:   Asymptomatic Intracranial Hemorrhage (asICH) Within 7 Days of Treatment Onset   [ Time Frame: Within 7 days of treatment onset ]

8.  Other Pre-specified:   Death Within 7 Days of Treatment Onset   [ Time Frame: Within 7 days of treatment onset ]

9.  Other Pre-specified:   Death Due to Stroke Within 7 Days of Treatment Onset   [ Time Frame: Within 7 days of treatment onset ]

10.  Post-Hoc:   Death Within 90 Days of Treatment Onset   [ Time Frame: Within 90 days of treatment onset ]

11.  Post-Hoc:   Death Due to Stroke Within 90 Days of Treatment Onset   [ Time Frame: Within 90 days of treatment onset ]

12.  Other Pre-specified:   NIH Stroke Scale Score (NIHSS) ≤ 5   [ Time Frame: Within 2 hours of treatment onset ]

13.  Other Pre-specified:   NIH Stroke Scale Score (NIHSS) ≤ 2   [ Time Frame: Within 24 hours of treatment onset ]

14.  Other Pre-specified:   NIH Stroke Scale Score (NIHSS) ≤2 at 90 Days   [ Time Frame: 90 days from treatment onset ]

15.  Post-Hoc:   Modified Rankin Scale (mRS) of 0-1   [ Time Frame: 90 days from treatment 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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Arthur Pancioli
Organization: University of Cincinnati
phone: 513-558-8087
e-mail: arthur.pancioli@uc.edu


Publications of Results:
Other Publications:

Responsible Party: Arthur Pancioli, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00894803     History of Changes
Other Study ID Numbers: P50NS04483-06, 00894803
Study First Received: May 6, 2009
Results First Received: November 27, 2013
Last Updated: March 26, 2014
Health Authority: United States: Food and Drug Administration