Journal article
Design of the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial
Journal of stroke and cerebrovascular diseases, Vol.20(4), pp.357-368
2011
DOI: 10.1016/j.jstrokecerebrovasdis.2011.05.001
PMCID: PMC3506385
PMID: 21729789
Abstract
Patients with recent transient ischemic attack (TIA) or stroke caused by 70% to 99% stenosis of a major intracranial artery are at high risk of recurrent stroke on usual medical management, suggesting the need for alternative therapies for this disease.
The Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis trial is an ongoing, randomized, multicenter, 2-arm trial that will determine whether intracranial angioplasty and stenting adds benefit to aggressive medical management alone for preventing the primary endpoint (any stroke or death within 30 days after enrollment or after any revascularization procedure of the qualifying lesion during follow-up, or stroke in the territory of the symptomatic intracranial artery beyond 30 days) during a mean follow-up of 2 years in patients with recent TIA or stroke caused by 70% to 99% stenosis of a major intracranial artery. Aggressive medical management in both arms consists of aspirin 325 mg per day, clopidogrel 75 mg per day for 90 days after enrollment, intensive risk factor management primarily targeting systolic blood pressure <140 mm Hg (<130 mm Hg in diabetics) and low density cholesterol <70 mg/dL, and a lifetsyle modification program. The sample size required to detect a 35% reduction in the rate of the primary endpoint from angioplasty and stenting based on the log-rank test with an alpha of 0.05, 80% power, and adjusting for a 2% loss to follow-up and 5% crossover from the medical to the stenting arm is 382 patients per group.
Enrollment began in November 2008 and 451 patients have been enrolled as of March 31, 2011.
This is the first randomized stroke prevention trial to compare angioplasty and stenting with medical therapy in patients with intracranial arterial stenosis and to incorporate intensive management of multiple risk factors and a lifestyle modification program in the study design. Hopefully, the results of the trial will lead to more effective therapy for this high-risk disease.
Details
- Title: Subtitle
- Design of the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial
- Creators
- Marc I Chimowitz - Department of Neurosciences, Stroke Center, Medical University of South Carolina, CharlestonMichael J Lynn - Department of Biostatistics, Emory University Rollins School of Public Health, Atlanta, GeorgiaTanya N Turan - Department of Neurosciences, Stroke Center, Medical University of South Carolina, CharlestonDavid Fiorella - Department of Neurosurgery, Cerebrovascular Center, State University of New York, Stony BrookBethany F Lane - Department of Biostatistics, Emory University Rollins School of Public Health, Atlanta, GeorgiaScott Janis - National Institute of Neurological Disorders and Stroke, National Institute of Health, Bethesda, MarylandColin P Derdeyn - Mallinckdrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, Saint Louis, Missouri
- Resource Type
- Journal article
- Publication Details
- Journal of stroke and cerebrovascular diseases, Vol.20(4), pp.357-368
- DOI
- 10.1016/j.jstrokecerebrovasdis.2011.05.001
- PMID
- 21729789
- PMCID
- PMC3506385
- NLM abbreviation
- J Stroke Cerebrovasc Dis
- ISSN
- 1052-3057
- eISSN
- 1532-8511
- Publisher
- Elsevier Inc
- Grant note
- U01 NS058728 / US Public Health Service National Institute of Neurological Disorders and Stroke (NINDS)
- Language
- English
- Date published
- 2011
- Academic Unit
- Neurology; Radiology; Iowa Neuroscience Institute; Neurosurgery
- Record Identifier
- 9984020768902771
Metrics
27 Record Views