Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Texas Biotech (TXB) -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (827)	3/22/2002 1:17:21 AM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 834

From EU Stroke conference (May): Reduction in Stroke-Associated Mortality in Patients with Heparin Induced Thrombocytopenia after Treatment with Direct Thrombin Inhibitor Argatroban M. P.Lamonte P.M.Brown K.L.Berens Texas Biotechnology University of Maryland, School of Medicine USA Argatroban (ARG), a direct thrombin inhibitor approved in the US for the prophylaxis and treatment of heparin-induced thrombocytopenia (HIT), is approved in Japan for use in acute ischemic stroke (AIS). AIS is rare in HIT, but the incidence is associated with a high mortality rate. We retrospectively evaluated the effects of ARG therapy on neurologic complications in 1,005 HIT patients. Upon diagnosis of HIT, heparin therapy was discontinued. ARG-treated patients (N=812) received an infusion (2 µg/kg/min) adjusted to achieve an aPTT of 1.5-3.0 times baseline and were compared to 193 historical controls (HC) treated with standard of care on other anticoagulation. Stroke-associated mortality was significantly lower among ARG-treated patients compared to HC (1.0 vs. 3.1 %, p=0.035). Stroke events occurred more frequently in females in both groups (14/20 and 6/8, ARG and HC, respectively) and 86% of all stroke events occurred within 14 days of HIT diagnosis. These results should alert physicians to be aware of a high risk of stroke complications in female patients and within 2 wks of HIT diagnosis. Decreased mortality and a lack of treatment-related intracerebral hemorrhage suggest Argatroban may be safe in the setting of AIS. A randomized, placebo-controlled trial of ARG in AIS is ongoing to test safety. A Randomized, Placebo-Controlled Study to Determine the Safety and Efficacy of Argatroban Injection in Patients with Acute Ischemic Stroke (ARGIS-1) M. P.Lamonte P.M.Brown D.M.Evans Texas Biotechnology University of Maryland School of Medicine USA Argatroban Injection (argatroban), a synthetic, small molecule, direct thrombin inhibitor, is capable of inhibiting the action of both free and clot-associated thrombin. Observations in rat MCA occlusion models demonstrated that Argatroban could significantly reduce the size of infarct and the number of microthrombi. Other studies suggest Argatroban directly inhibits secondary microthrombus formation in acute stages of ischemic stroke. The mode of action of Argatroban in cerebral thrombosis is explained as the inhibition of the local thrombin formed due to ischemic tissue damage. By preventing subsequent thrombus formation in the penumbral microcirculation, it is hypothesized that improved blood flow to the peri-ischemic/penumbra would rescue neuronal cells at risk. The purpose of this double-blind, placebo-controlled trial is to determine if Argatroban is safe and feasible as an effective treatment in AIS within 0-12 hours of symptom onset. Patients receive a bolus over 3-5 minutes followed by either a low dose or high dose infusion of Argatroban titrated to achieve a target aPTT of 1.75 or 2.25 times baseline. The primary outcome is to determine the safety of Argatroban, as measured by the incidence of major bleeding. The secondary outcomes are to determine an effective dose and to assess stroke outcome in relationship to administration of Argatroban as measured by mRS, BI and NIHSS. The tertiary outcome is survival at 90 days. A total of 55 centers (N. America) are participating to enroll 180 evaluable patients ages 18-85 years with a baseline NIHSS between 5 and 22, inclusive. Neurological assessments are obtained at baseline, during treatment, post-treatment and at 30 and 90 days. Completion of enrollment is anticipated in second quarter 2002.