Neuroprotection With Statin Therapy for Acute Recovery Trial Phase 2 (NCT01976936) | Clinical Trial Compass
CompletedPhase 2
Neuroprotection With Statin Therapy for Acute Recovery Trial Phase 2
United States162 participantsStarted 2009-02
Plain-language summary
This trial will be a phase 2 randomized safety study in which ischemic stroke patients will be randomly assigned within 24 hours of symptom onset to placebo or standard dose lovastatin versus short-term high-dose lovastatin 640 mg per day for 3 days. The primary outcome of this Phase 2 study will be musculoskeletal and hepatic toxicity, defined by clinical and laboratory criteria, with a 3-month follow-up period (± 1 week). Secondary outcomes will include neurological outcome (National Institute of Health (NIH) Stroke Scale), functional outcomes (Barthel Index), and handicap (modified Rankin scores). Effects on inflammatory markers and lipid levels will also be assessed.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age \>18
✓. Satisfies the criteria for ischemic stroke: acute focal neurological deficit of likely ischemic vascular origin.
✓. Patient or legally authorized representative has provided written informed consent prior to study entry. Patient who regains capacity provides his/her written consent to remain in the study.
✓. Patient can receive the first treatment dose within 0-24 hours of stroke onset. For patients found with stroke on awakening, it will be assumed that the stroke occurred the last time that the patient was known to be normal.
✓. Patient has pretreatment brain CT scan compatible with ischemic stroke and excludes hemorrhagic and non-vascular etiologies of symptoms.
✓. Patients taking statins at time of stroke may be included.
✓. Patients receiving standard dose intravenous tPA or mechanical interventional procedures may be enrolled.
Exclusion criteria
✕. Brain imaging study shows a lesion other than ischemic stroke that could explain patient's symptoms (intracranial or subarachnoid hemorrhage, arteriovenous malformation, aneurysm, multiple sclerosis, tumor, abscess or other). Asymptomatic meningiomas are allowed.
What they're measuring
1
Total Number of Participants With an Increase in Liver Function Tests (LFTs)
✕. Mild stroke, defined as NIH Stroke Scale \<2.
✕. Weight \< 50 kg.
✕. Patient is comatose, regardless of etiology (\> 4 points on the first three items of the NIHSS).
✕. History of intolerance or allergic reaction to any statins (myotoxicity, hepatic dysfunction, rash, etc.)
✕. Use of drugs within past 30 days that utilize the cytochrome CYP3A pathway (cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, nefazodone, posaconazole, voriconazole, dronedarone, diltiazem, colchicine and ranolazine).
✕. Use of drugs within past 30 days that increase risk of myotoxicity with statins (gemfibrozil, other fibrates, niacin, amiodarone, verapamil).
✕. Baseline major electrolyte disturbances (sodium \<125 or \>150, potassium \<3.0 or \>5.5).