ISC: Stroke Trial Halted when Ticlopidine Fails to Outperform Aspirin in African Americans
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ISC: Stroke Trial Halted when Ticlopidine Fails to Outperform Aspirin in African Americans

By Charlene Laino
Special to DG News

PHOENIX, AZ -- February 18, 2003 -- The first prospective randomized double blind study to exclusively enroll African American patients who had suffered an ischemic stroke was halted prematurely when ticlopidine hydrochloride was found to be no more effective than aspirin at preventing recurrent stroke, myocardial infarction and vascular death, U.S. researchers report.

"We were surprised ticlopidine did not outperform aspirin in the primary end point, which was a composite measure of vascular death, myocardial infarction or recurrent stroke," said investigator Phillip B. Gorelick, MD, of the Center for Stroke Research at Rush Medical College, Chicago, Illinois, United States. Dr. Gorelick presented the results here on February 15th at the 28th International Stroke Conference.

Although stroke disproportionately affects African Americans, black patients have been underrepresented in stroke clinical trials, he said.

The African American Antiplatelet Stroke Prevention Study was an investigator-initiated trial using an intention-to-treat analysis to compare the effectiveness and safety of 500 mg of ticlopidine hydrochloride daily with 650 mg of aspirin daily in African Americans.

From 1995 to 2001, They enrolled 1,809 African Americans between 7 and 90 days of non-cardioembolic ischemic stroke. Eighty-five percent of patients had hypertension, 42% had high cholesterol levels and 42% were diabetic, Dr. Gorelick said. Most had a body-mass index of 30 or greater, and 66% had bilunar infarcts.

The researchers utilized 2-sided testing procedures and 80% power to detect a 30% risk reduction of the primary outcome end point, he said.

After extensive review of the interim analysis results, completed in Spring 2002, the National Institutes of Health-appointed Patient and Safety Monitoring Board decided to halt the blinded phase of the study, he reported. The reason: Ticlopidine did not perform as well as aspirin (p=0.08), Dr. Gorelick said.

"The analysis showed ticlopidine would have less than 1% efficacy so all patients were turned over for open-label aspirin," he added.

Despite the disappointing results, Dr. Gorelick said the findings offer important lessons that will be useful for planning and conducting future stroke prevention studies in African Americans and other high-risk groups, and will help to clarify the role of ticlopidine and aspirin in prevention of recurrent stroke.

The National Institute of Neurological Disorders and Stroke sponsored the trial.

[Study title: African American Antiplatelet Stroke Prevention Study (Aaasps): Main Phase Efficacy And Safety Results
Abstract 99]


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