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Stroke Interventions in Clinical Trials
Printable Version
Tirilazad mesylate
Freedox®

Action
Lipid peroxidation inhibitor

Status
RANTTAS-1 tested tirilazad, 6 mg/kg per day for 3 days. RANTTAS-1 was stopped after 660 patients had been randomized, because interim analysis suggested lack of efficacy. Phase III trial of higher dose (RANTTAS II) was stopped after 126 patients had been enrolled, when questions regarding safety emerged from a parallel study in Europe. "Tirilazad treatment was associated with an absolute reduction in mortality of 14% and an increase in the proportion of patients who were independent. . . The observed differences were not statistically significant." US trial in head trauma halted in 1994 because of concerns of excess mortality. Tirilazad has also been tested in spinal cord injury and subarachnoid hemorrhage.

Trial(s)
  = Ongoing
  = Completed

High-dose tirilazad mesylate in women with aneurysmal subarachnoid hemorrhage - Part I.
High-dose tirilazad mesylate in women with aneurysmal subarachnoid hemorrhage-Part II.
Phase II trial of tirilazad in aneurysmal subarachnoid hemorrhage
Randomized, double-blind, placebo-controlled trial of tirilazad mesylate in subarachnoid hemorrhage: cooperative study in North America
Randomized, double-blind, placebo-controlled trial of tirilazad mesylate: a cooperative study in Europe, Australia, and New Zealand
RANTTAS II Randomized Trial of High Dose Tirilzad in Acute Stroke
RANTTAS Randomized Trial of Tirilazad Mesylate in Acute Stroke

Web Links and Publications
Pharmacia Web Site.

Tirilazad for acute ischaemic stroke (Cochrane Review).
Cochrane Database Syst Rev. 2001;4:CD002087.

Tirilazad mesylate in acute ischemic stroke : A systematic review.
Stroke 2000 Sep;31(9):2257-65

Double-blind, randomized, vehicle-controlled study of high-dose tirilazad mesylate in women with aneurysmal subarachnoid hemorrhage. Part I. A cooperative study in Europe, Australia, New Zealand, and South Africa.
J Neurosurg. 1999 Jun;90(6):1011-7.

Double-blind, randomized, vehicle-controlled study of high-dose tirilazad mesylate in women with aneurysmal subarachnoid hemorrhage. Part II. A cooperative study in North America.
J Neurosurg. 1999 Jun;90(6):1018-24.

High-dose tirilazad for acute stroke (RANTTAS II). RANTTAS II Investigators.
Stroke 1998 Jun;29(6):1256-7. No abstract available.

Infarct volume as a surrogate or auxiliary outcome measure in ischemic stroke clinical trials. The RANTTAS Investigators.
Stroke 1999 Feb;30(2):293-8.

Too little, too late: does tirilazad mesylate reduce fatigue after subarachnoid hemorrhage?
Neurosurgery 1998 Oct;43(4):782-7

A multicenter trial on the efficacy of using tirilazad mesylate in cases of head injury.
J Neurosurg 1998 Oct;89(4):519-25

Economic analysis of tirilazad mesylate for aneurysmal subarachnoid hemorrhage. Economic evaluation of a phase III clinical trial in Europe and Australia.
Int J Technol Assess Health Care 1998 Winter;14(1):145-60

Randomized, double-blind, vehicle-controlled trial of tirilazad mesylate in patients with aneurysmal subarachnoid hemorrhage: a cooperative study in Europe, Australia, and New Zealand.
J Neurosurg 1996 Feb;84(2):221-8.

Phase II trial of tirilazad in aneurysmal subarachnoid hemorrhage. A report of the Cooperative Aneurysm Study.
J Neurosurg 1995 May;82(5):786-90.

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