Journal article
SAFETY STUDY OF TIRILAZAD MESYLATE IN PATIENTS WITH ACUTE ISCHEMIC STROKE (STIPAS)
Stroke (1970), Vol.25(2), pp.418-423
02/01/1994
DOI: 10.1161/01.STR.25.2.418
PMID: 8303754
Abstract
Background and Purpose Tirilazad mesylate, a 21-aminosteroid, is a potent membrane lipid peroxidation inhibitor and free radical scavenger that has shown promise in animal models of focal cerebral ischemia. Safety in patients with acute ischemic stroke has not yet been established. Methods The study comprised a randomized (three drugs to one vehicle), vehicle-controlled, double-blind, sequential dose-escalation trial at five centers. Treatment was begun within 12 hours of stroke onset and was continued intravenously for 3 days. Results One hundred eleven patients (mean+/-SD age, 66+/-13 years; 56% male) were enrolled in three successive dosage tiers: 36 at 0.6 mg/kg per day, 35 at 2.0 mg/kg per day, and 40 at 6.0 mg/kg per day. Median time from stroke onset to treatment was 8.5 (range, 3 to 12) hours and was not significantly different among the groups. Tirilazad was well tolerated at all three doses, except for mild-to-moderate injection site irritation that occurred in both the tirilazad- and vehicle-treated groups. No significant differences in measures of either cardiac or hepatic toxicity were observed in this small sample. Imbalances in baseline medical and neurological condition made comparisons of outcome difficult. Although no evidence suggestive of tirilazad efficacy was apparent in this study, the trial was not designed to test for differences in outcome. Conclusions These observations suggest that intravenous tirilazad at doses of up to 6.0 mg/kg per day for 3 days is well tolerated in this population of predominantly elderly stroke patients. Larger studies with earlier treatment will be needed to demonstrate efficacy.
Details
- Title: Subtitle
- SAFETY STUDY OF TIRILAZAD MESYLATE IN PATIENTS WITH ACUTE ISCHEMIC STROKE (STIPAS)
- Creators
- E C Haley - University of VirginiaS Putman - Carolinas Medical CenterF Anderson - Carolinas Medical CenterM R Morrison - Carolinas Medical CenterP TuttleB T Passini - Carolinas Medical CenterA N Wilner - Carolinas Medical CenterF H Allen - Carolinas Medical CenterR Adams - Medical College of GeorgiaB Carl - Medical College of GeorgiaC Bueke - Medical College of GeorgiaF Nichols - Medical College of GeorgiaD Hess - Medical College of GeorgiaS Hyder - Medical College of GeorgiaG Burch - Carilion Roanoke Memorial HospitalC Foley - Carilion Roanoke Memorial HospitalD H Bivins - Carilion Roanoke Memorial HospitalJ T Wilson - Carilion Roanoke Memorial HospitalM A Sisk - Carilion Roanoke Memorial HospitalD B Nolan - Carilion Roanoke Memorial HospitalW S Elias - Carilion Roanoke Memorial HospitalG L Sheppard - Winchester Medical CenterN F Crowe - Winchester Medical CenterS Massey - Winchester Medical CenterD Hurst - Winchester Medical CenterD Zontine - Winchester Medical CenterK H Gustin - Winchester Medical CenterK Mcclure - University of VirginiaM Granner - University of VirginiaS Wolf - University of VirginiaM Gwynn - University of VirginiaR W Mettetal - University of VirginiaJ C TornerG Kongable - University of VirginiaS Wilkinson - University of VirginiaC A Hansen - University of VirginiaM C Wolff - University of VirginiaR S Gibson - University of VirginiaJ D Bergin - University of VirginiaL Truskowski - University of VirginiaG Lightfoot - University of VirginiaA Lightfoot - University of VirginiaA Polin - University of VirginiaN J Solenski - University of VirginiaJ Stiteler - University of VirginiaG R Peters - Pfizer,W J Bryan - Pfizer,STIPAS Investigators
- Resource Type
- Journal article
- Publication Details
- Stroke (1970), Vol.25(2), pp.418-423
- DOI
- 10.1161/01.STR.25.2.418
- PMID
- 8303754
- NLM abbreviation
- Stroke
- ISSN
- 0039-2499
- eISSN
- 1524-4628
- Publisher
- Amer Heart Assoc
- Number of pages
- 6
- Language
- English
- Date published
- 02/01/1994
- Academic Unit
- Neurology; Epidemiology; Injury Prevention Research Center; Neurosurgery
- Record Identifier
- 9984302214402771
Metrics
10 Record Views