Low molecular weight heparinoid, ORG 10172 (danaparoid), and outcome after acute ischemic stroke: a randomized controlled trial. The Publications Committee for the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) Investigators.
Abstract | CONTEXT: OBJECTIVE: DESIGN: Randomized, double-blind, placebo-controlled, multicenter trial. SETTING AND PARTICIPANTS: Between December 22, 1990, and December 6, 1997, 1281 persons with acute stroke were enrolled at 36 centers across the United States. INTERVENTION: A 7-day course of ORG 10172 or placebo was given initially as a bolus within 24 hours of stroke, followed by continuous infusion in addition to the best medical care. Doses were adjusted in response to anti- factor Xa activity. MAIN OUTCOME MEASURES: Favorable outcome rated as the combination of a Glasgow Outcome Scale score of I or II and a modified Barthel Index of 12 or greater on a scale of 0 to 20 at 3 months or 7 days; very favorable outcome was recorded for the combination of a Glasgow Outcome Scale of I and a Barthel Index of 19 or 20 at 3 months or 7 days. RESULTS: At 3 months, 482 (75.2%) of 641 persons assigned to treatment with ORG 10172 and 467 (73.7%) of 634 patients treated with placebo had favorable outcomes (P=.49); 49.5% and 47%, respectively, of patients in each group had very favorable outcomes at 3 months. At 7 days, 376 (59.2%) of 635 persons given ORG 10172 and 344 (54.3%) of 633 receiving placebo had favorable outcomes (P=.07). For the same interval, 215 (33.9%) of 635 persons given ORG 10172 and 176 (27.8%) of 633 persons administered placebo had very favorable outcomes (P=.01; odds ratio, 1.36; 95% confidence interval, 1.06-1.73). Within 10 days of onset of treatment, serious intracranial bleeding events occurred in 14 patients given ORG 10172 (15 events) and in 4 placebo-treated patients (5 events) (P=.05). CONCLUSION: Despite an apparent positive response to treatment at 7 days, emergent administration of the antithrombotic agent, ORG 10172, is not associated with an improvement in favorable outcome at 3 months.
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Authors | |
Journal | JAMA
(JAMA)
1998 Apr 22-29
Vol. 279
Issue 16
Pg. 1265-72
ISSN: 0098-7484 [Print] United States |
PMID | 9565006
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Anticoagulants
- Drug Combinations
- Heparinoids
- Dermatan Sulfate
- Chondroitin Sulfates
- Heparitin Sulfate
- danaparoid
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Topics |
- Aged
- Anticoagulants
(administration & dosage, adverse effects, therapeutic use)
- Brain Ischemia
(drug therapy, physiopathology)
- Cerebral Hemorrhage
(etiology)
- Chondroitin Sulfates
(administration & dosage, adverse effects, therapeutic use)
- Dermatan Sulfate
(administration & dosage, adverse effects, therapeutic use)
- Double-Blind Method
- Drug Combinations
- Female
- Glasgow Coma Scale
- Heparinoids
(administration & dosage, adverse effects, therapeutic use)
- Heparitin Sulfate
(administration & dosage, adverse effects, therapeutic use)
- Humans
- Infusions, Intravenous
- Male
- Middle Aged
- Survival Analysis
- Treatment Outcome
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