ACSI
Azithromycin for the prevention of the progression of ischemic cerebral lesions in patients surviving a non-cardioembolic cerebral infarct
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Status:
Enrollment completed. Follow-up was also completed the end of 2005 and currently the collected data is being processed with results expected in November or December of 2008.
Purpose:
To assess whether whether azithromycin reduces the progression of ischemic cerebral lesions on MRI in stroke patients surviving a non-cardioembolic cerebral infarct
Location(s):
The Netherlands
Year Started:
2000
Year Finished:
2005
Design:
Randomized trial.
Inclusion Criteria
Patients with atherosclerosis as cause of the stroke.
Exclusion Criteria
Patients with cardial embolism, hematologic disorders, other rare causes of stroke and patients scheduled for carotid endarterectomy.
Patient Involvement:
Patients are randomized to receive either Azithromycin 500 mg/day for 3 days, followed by 500mg / week for 12 weeks or placebo. Follow-ups are at 3, 6, 12, 18 and 24 months.
Primary Outcome:
The increase in number of lacunar infarcts and severity of diffuse cerebral ischemic damage (leukoaraiosis) on T2 weighted MRI images of the brain.
Secondary Outcome:
Cerebro- or cardiovascular events, and vascular death. Change in the degree of cognitive score measured by CAMCOG. Functional decline measured by Rankin scale and Barthel index; Increase in IMT of common carotid artery; Serum parameters: antibodies against CP, hsCRP; Presence of CP in peripheral blood monocytes (PBMC).
Source of Information:
Presented at the 29th International Stroke Conference [February 2004].
Correspondence with PI.
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Web Links and Publications:
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This information last updated on: 7/16/2008
Reviewed on: 10/19/2009.
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