IV vs. IA tPA (Activase) in Acute Ischemic Stroke With CTA Evidence of Major Vessel Occlusion
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Status:
Study is completed and results have been published.
Purpose:
To test the feasibility and provide preliminary safety data regarding the relative benefits and risks of IA Activase as compared to IV Activase when administered per the NINDS rt-PA stroke study protocol, i.e. randomized within 3 hours of onset of symptoms of ischemic stroke then treated within 3 hours in the IV Activase arm and within 4 hours in the IA Activase arm.
Interventions:
Altepase IV vs IA
A form of tissue plasminogen activator. It helps dissolve blood clots and is used to treat heart attacks, strokes, and clots in the lungs.
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Location(s):
North Carolina
Year Started:
2004
Year Finished:
2006
Design:
Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study.
Inclusion Criteria
•Ability to provide written informed consent and comply with study assessments for the full duration of the study; NIHSS ≥ 4 or isolated aphasia or isolated hemianopsia.
Exclusion Criteria
NIHSS >30; coma; rapidly improving symptoms; history of stroke in the last 6 weeks; seizure at onset; Subarachnoid Hemorrhage (SAH ) or suspected SAH; any history of Intracrannial Hemorrhage (ICH); neoplasm; septic embolism;
surgery, biopsy, trauma or LP in last 30 days; head trauma in the last 90 days; bleeding diathesis, or INR >1.7 or PTT >1.5 times baseline or platelet <100K; SBP >180 or DBP ≥100 despite treatment with 3 doses of IV Labetalol (10-20 mg Q10"); Lacunar stroke syndrome; CT: Hemorrhage, tumor (except small meningioma), significant mass effect, midline shift, acute hypodensity or >1/3 MCA territory sulcal effacement; radiological contrast hypersensitivity; angiographic: dissection, lack of access, lack of occlusion, or nonatherosclerotic arteriopathy.
Patient Involvement:
Patients will be randomized within 3 hours of onset of symptoms of ischemic stroke then treated within 3 hours in the IV Activase arm and within 4 hours in the IA Activase arm. Patient will have 90-day efficacy outcome including NIHSS, modified Rankin Scale and Barthel's Index; 24-h recanalization (TIMI 2/3) on MRA or CTA.
Primary Outcome:
•Feasibility of enrolling 12 subjects with major vessel occlusion within 1 year and random 1:1 assignment to treatment with IV (N=6) and IA (N=6) IA Activase using the following criteria: Time to clinical and radiological assessments; time to IA Activase treatment; preliminary safety assessment: 24 hour symptomatic ICH; resources utilized and risk-benefit of IA Activase treatment.
Secondary Outcome:
90-day efficacy outcome including NIHSS, modified Rankin Scale and Barthel's Index; 24-h recanalization (TIMI 2/3) on MRA or CTA; major extracranial bleed (defined under section 3.3.3) and asymptomatic intracranial hemorrhage.
Results:
Seven patients (median NIHSS = 16) were randomized to IV (N = 4) or IA (N = 3) TPA. There were no significant differences in the presentation NIHSS, time to presentation, or time to treatment between the two groups. Hemorrhage was noted in one patient in the IA group (asymptomatic) and one patient in the IV group (symptomatic). Recanalization was seen in all patients treated with IA TPA and none treated with IV TPA (P = 0.03, Fisher's Exact test). In conclusion, we found that it is feasible to conduct a trial comparing IV vs. IA TPA in ischemic stroke patients with major vessel occlusion presenting <3 h from onset. Patients treated with IA TPA showed a trend toward higher rate of recanalization. A larger trial may be designed to test safety and effectiveness of IA TPA in this specific group of stroke patients.
Source of Information:
ClinicalTrials.gov
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This information last updated on: 11/6/2009
Reviewed on: 11/06/2009.
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