BACKGROUND: Under the current treatment guidelines for acute ischemic stroke, intravenous alteplase may be used within 3-4.5 hours of symptom recognition or in cases of unknown onset if there is a small lesion on diffusion weighted imaging without increased signal on FLAIR sequence MRI. We seek to determine whether patients with lacunar strokes greater than 4.5 hours post onset with a DWI-FLAIR mismatch on imaging will benefit from thrombolysis with intravenous alteplase.
METHODS: We will conduct a multicenter, randomized, double-blinded, placebo-controlled trial of patients presenting with acute ischemic stroke within 4.5 to 6 hours of symptom onset with DWI-FLAIR mismatch and without a large vessel occlusion. A target of 682 patients will be randomized to receive IV alteplase or placebo. The primary outcome is a favorable functional status as defined by a score of 0 or 1 on the modified Rankin scale (mRS) at 90 days. The secondary outcome is ordinal score on the modified Rankin scale at 90 days. The primary safety end points will be symptomatic intracranial hemorrhage (sICH) and death
CONCLUSIONS: If intravenous (IV) alteplase is found to be an effective and safe treatment for lacunar stroke with DWI-FLAIR mismatch >4.5 hours from onset, these patients could have significantly reduced morbidity and improved long-term outcomes.
| Identifer | oai:union.ndltd.org:bu.edu/oai:open.bu.edu:2144/42094 |
| Date | 20 February 2021 |
| Creators | Ganz, Lily |
| Contributors | Shulman, Julie, Weinstein, John R. |
| Source Sets | Boston University |
| Language | en_US |
| Detected Language | English |
| Type | Thesis/Dissertation |
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