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June 10, 2003 — Aspirin appears to be the better treatment than the antiplatelet drug ticlopidine for preventing recurrent stroke in black patients, according to a study in the June 11 issue of The Journal of the American Medical Association (JAMA). "Blacks are disproportionately affected by stroke, yet they have been underrepresented in clinical trials," the authors provide as background information in the study. "Recommendations for stroke prevention have been based largely on trials that have included few black participants." The authors add that blacks are about two times more likely than most other individuals in the United States to die of or experience stroke.
Philip B. Gorelick, M.D., M.P.H., from Rush Medical College, Chicago, and colleagues from the African American Antiplatelet Stroke Prevention Study (AAASPS) conducted a randomized, double-blind, multicenter clinical trial to evaluate the effectiveness and safety of aspirin and ticlopidine (a drug that blocks the action of platelets) to prevent recurrent stroke in black patients. The study included 1,809 black men and women who recently had a noncardioembolic ischemic stroke (strokes that were not due to bleeding in the brain or to blockage of a blood vessel in the brain due to an embolism [i.e., small clot] that originated from the heart.) Study participants were recruited for the study between December 1995 and October 2001. The patients received either a 500 mg/daily dose of ticlopidine (n= 902) or 650 mg/daily of aspirin (n= 907). The study participants were examined in person at baseline; every two weeks during the first three months; and at six, 10, 12, 16, 20 and 24 months, and at any other time if the investigative team thought it necessary for patient safety. "We hypothesized that ticlopidine, a more global platelet inhibitor, would be more effective in black ischemic stroke patients with a substantial stroke and cardiovascular disease risk profile and that aspirin might prove to be an inferior platelet inhibitor in these high-risk patients," the authors state. "The blinded phase of the study was halted after about 6.5 years when futility analyses revealed a less than one-percent probability of ticlopidine being shown superior to aspirin in the prevention of the primary outcome end point (recurrent stroke, heart attack or vascular death)," the authors report.
The primary outcome occurred in 133 (14.7 percent) patients assigned to ticlopidine and 112 (12/3 percent) patients assigned to aspirin. The authors also suggest that, "These analyses also indicated a 40 percent to 50 percent likelihood of aspirin being significantly better than ticlopidine in reducing the risk of recurrent fatal or nonfatal stroke if the trial were to continue to completion." The authors conclude: "Aspirin is much less expensive than other major antiplatelet agents, is readily available, easy to use, and relatively safe. Head-to-head comparison with other agents indicates that it may be difficult to outperform aspirin as a stroke prevention therapy in some noncardioembolic ischemic stroke patients." ... "Therefore, aspirin is a reasonable first choice prevention agent in aspirin-tolerant black patients with noncardioembolic ischemic stroke."
Editorial: Preventing Stroke Among Blacks — The Challenges Continue
In an accompanying editorial, Ralph L. Sacco, M.S., M.D., from the New York Presbyterian Hospital, New York, writes that "stroke continues to have a disproportionate public health impact on blacks compared with whites in the United States." ... "In this issue of The Journal, Gorelick and colleagues report a clear example of a focused, hypothesis-driven, randomized treatment trial addressing an important problem among blacks with stroke." "The AAASPS has clinical implications for the prevention of recurrent stroke. It provides new data on an alternate antiplatelet agent that should no longer be recommended for prevention of recurrent stroke — certainly not in black patients." "The AAASPS provides supportive evidence for the use of aspirin, an inexpensive and widely available therapy, to reduce the risk of stroke recurrence among black patients. All stroke survivors should receive some form of antithrombotic therapy and clinicians need to consider cost when choosing the best medication, especially for certain high-risk groups."