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