TOAST is a randomized, multi-center, placebo-controlled, double-blind
clinical trial testing the efficacy and safety of a low molecular weight
heparinoid (ORG 10172) in improving the outcome of patients with acute
ischemic stroke. Funded by the National Institute of Neurological Diseases
and Stroke (NINDS), this project has completed recruitment, enrolling
1281 patients at a total of 39 Clinical Centers. General medical, neurologic,
hematologic, and radiologic data was collected on these patients using
standardized case report forms over a seven-day acute treatment period and
at a three month follow-up.
The CTDMC was active in the initial development and design of the TOAST
trial, which included working with a separately-funded Clinical Coordinating
Center, NINDS, and the TOAST Operations Committee in all phases of study
design and protocol formulation. The CTDMC had primary responsibility
for development of treatment allocation procedures, the data analysis
plan, and the data collection and management systems. The CTDMC was responsible
for performing interim reports for both an In-House Safety Committee and
the NINDS Safety and Monitoring Committee. Data from TOAST are currently
being analyzed by the CTDMC.