AZ Guide u CLINICAL TRIAL
STROKE

CARE Study
Cholesterol and Recurrent Events

CARE was a multicenter randomized, double-blind, placebo-controlled trial of 4,159 patients with total cholesterol < 240 mg/dl (mean 209) and average LDL-cholesterol (115-174 mg/dl, mean 139) following myocardial infarction. This study has compared Pravastatin 40 mg/day to placebo.
Stroke incidence was reduced with Pravastatin by 32% (p= 0.03).
Stroke or TIA incidence was reduced by 27% (p=0.02).


CAS
Asymptomatic Carotid Atherosclerosis Study

  • The endarterectomy in patients with an asymptomatic stenosis results in a 5.8% absolute risk reduction of fatal and nonfatal ipsilateral stroke.

(JAMA 1995; 237: 1421-1428)


NASCET
North American Symptomatic Carotid Endarterectomy Trial

  • Symptomatic patients with high-grade carotid stenosis were randomized to either medical treatment or best medical treatment plus carotid endarterectomy.
  • NASCET demonstrated that endarterectomy was superior to medical management in reducing the risk of stroke.
    (N Engl J Med 1991; 325: 445-453)
  • At the end of December 1997, NASCET has followed-up 2,226 patients randomized to medical therapy (n= 1,118) or carotid endarterectomy (CE).

NINDS rt-PA stroke trial

This trial showed that rt-PA, given within 3 hours of symptom onset, improves outcome 3 months post-stroke.
Additional analysis that patients treated with rt-PA were at least 30% more likely than placebo group to have minimal or no disability at 6 months and 1 year.
The patients were contacted by telephone for:

  • status (alive or dead)
  • ability to perform daily activities (Barthel Index)
  • assessment of functional disability (modified Rankin and Glasgow Outcome Scales).

TOAST
Trial of Org 10172 in Acute Stroke Treatment

TOAST was a 38 center randomized, double-blind, placebo controlled trial of the low molecular weight heparinoid , Org 10172 in the treatment of acute ischemic stroke.
The outcome was assessed at 7 days and 3 months after stroke using the Barthel Index (BI) and Glasgow Outcome Scale (GOS).

 

Treatment with Org 10172

Placebo

P

Favorable outcomes at 7 days

59.2%

54.3%

0.072

Favorable outcomes at 3 months

75.2%

73.7%

0.624

 

AZ Guide - Clinical Trial / Stroke
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