Feasibility Study of IV Recombinant Tissue Plasminogen Activator (rtPA) vs. Primary Endovascular Therapy for Acute Ischemic Stroke (EARLY)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Stroke Ischemic Stroke||Drug: Intravenous Thrombolysis Device: Endovascular Arterial Reperfusion||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Endovascular Arterial Reperfusion vs. Intravenous ThromboLYsis for Acute Ischemic Stroke (EARLY): A Randomized Pilot Study of Ultra-early (<2 Hours) and Early (2-4.5 Hours) Reperfusion Therapy|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Active Comparator: 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.
Drug: Intravenous Thrombolysis
Other Name: Altelplase, rtPA
Active Comparator: 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.
Device: Endovascular Arterial Reperfusion
Other Name: Penumbra, Solitaire
- Recanalization Rate of Primary Intracranial Occlusion [ Time Frame: 24 hours ]The degree of recanalization (none, partial, complete) will be assessed in a blinded fashion on the 24-hour computed tomographic angiogram (CTA).
- Mean Score on Modified Rankin Scale at 90 Days [ Time Frame: 90 days ]Functional outcome at 90-days will be assessed with the modified Rankin Scale (mRS). The Modified Rankin Scale was completed by the physician; it is a 7 point scale rating any limitations in the study subject's social role. The scale ranges from 0 (no symptoms/disability) to 6 (death).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869478
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Kevin M Barrett, MD||Mayo Clinic|