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Feasibility Study of IV Recombinant Tissue Plasminogen Activator (rtPA) vs. Primary Endovascular Therapy for Acute Ischemic Stroke (EARLY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01869478
Recruitment Status : Terminated (Poor recruitment)
First Posted : June 5, 2013
Results First Posted : October 5, 2016
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Stroke
Ischemic Stroke
Interventions: Drug: Intravenous Thrombolysis
Device: Endovascular Arterial Reperfusion

  Participant Flow

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
Intravenous Thrombolysis 0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
Endovascular Arterial Reperfusion Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.

Participant Flow:   Overall Study
    Intravenous Thrombolysis   Endovascular Arterial Reperfusion
STARTED   0   1 
COMPLETED   0   1 
NOT COMPLETED   0   0 



  Baseline Characteristics

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 Thrombolysis 0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
Endovascular Arterial Reperfusion Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
Total Total of all reporting groups

Baseline Measures
   Intravenous Thrombolysis   Endovascular Arterial Reperfusion   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   1   1 
Age 
[Units: Participants]
     
<=18 years      0   0 
Between 18 and 65 years      1   1 
>=65 years      0   0 
Gender 
[Units: Participants]
     
Female      1   1 
Male      0   0 
Region of Enrollment 
[Units: Participants]
     
United States      1   1 


  Outcome Measures

1.  Primary:   Recanalization Rate of Primary Intracranial Occlusion   [ Time Frame: 24 hours ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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 terminated due to difficulty in recruiting subjects.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kevin M. Barrett, MD
Organization: Mayo Clinic
phone: 904-953-9740
e-mail: Barrett.Kevin@mayo.edu



Responsible Party: Kevin M. Barrett, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01869478     History of Changes
Other Study ID Numbers: 12-002496
First Submitted: June 1, 2013
First Posted: June 5, 2013
Results First Submitted: August 12, 2016
Results First Posted: October 5, 2016
Last Update Posted: October 5, 2016