Targeted Recurrent Stroke Prevention Study For Blacks example essay topic

Blacks are disproportionately affected by stroke, yet they have been underrepresented in clinical trials. Recommendations for stroke prevention in this population have been based largely on trials that have included few black participants. This may not be an optimal practice because blacks are among those with a higher prevalence of major cardiovascular risk factors, a different distribution of atherosclerotic occlusive cerebral vascular lesions, vascular biological differences such as low renin hypertension, and a different pattern of use of medical procedures and access to care that could influence outcome. A subgroup analysis of the Ticlopidine Aspirin Stroke Study (TASS) suggested a more favorable risk-benefit profile for nonwhites than whites.

Specifically, among the 495 black and 108 nonwhite and non black study participants, there was a 24.1% relative risk reduction ( ) for stroke and death at 2 years favoring ticlopidine (500 mg / d ) over aspirin (1300 mg / d ), and 10% fewer serious adverse events (Sales). Overall in TASS, there was a 12% for nonfatal stroke or death from any cause (P = . 05) favoring ticlopidine at 3 years. The current study was designed in 1993, with the belief that a targeted recurrent stroke prevention study for blacks was justified given their disproportionate stroke burden, promising data for ticlopidine as a recurrent stroke preventive treatment in nonwhites, and the lack of previous substantial representation of blacks in stroke clinical trials. The primary outcome of the African American Antiplatelet Stroke Prevention Study ( SPS) was the composite end point of recurrent stroke, myocardial infarction, or vascular death.

A description of the design and methods of SPS has been reported previously in accordance with criteria proposed by the Consolidated Standards of Reporting Trials. That article 16 included a discussion of barriers to black participation in clinical trials and how they were overcome, the rationale for study drug selection, relationships established with primary care physicians, management of cardiovascular risk factors, and other major aspects of the study. The diagnosis of stroke and stroke subtype was determined after review of source documents and case report forms and by application of criteria from the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) 21 by local principal investigators for the entry stroke and by the SPS adjudication committee for all outcome events. Entry and outcome stroke cases received computed tomography or magnetic resonance imaging of the head. At the time our study design was developed in the early to mid-1990's, we believed that there was uncertainty about the preferred aspirin dose for recurrent stroke prevention. Given this uncertainty, we opted for an aspirin dose of 650 mg / d in accordance with the recommendations by Barnett et al.

Eligibility criteria included black (African American) race; 29-85 years of age inclusive; noncardioembolic ischemic stroke with onset at least 7 days but not more than 90 days; cranial computed tomographic scan or magnetic resonance image of the brain consistent with occurrence of the entry cerebral infarct; measurable neurological deficit that correlates at onset with entry cerebral infarct; informed consent; and availablity of patient to be followed up in an outpatient treatment program. Exclusion criteria included transient ischemic attack, subarachnoid hemorrhage, cardiac source embolism, iatrogenic stroke, non atherosclerotic stroke, postoperative stroke occurring within 30 days of operation, or carotid endarterectomy as primary treatment measure for entry cerebral infarct; mean arterial blood pressure higher than 130 mm Hg on 3 consecutive days; modified Barthes index of less than 10; history of dementia or neurodegenerative disease; severe comorbid condition (eg, cancer) judged to limit survival during 2-year follow-up; enrollment in another clinical trial; allergy or sensitivity to study drugs; woman of childbearing potential; gastrointestinal tract bleeding, bleeding diathesis, or platelet or other hematologic abnormality (judged to be a contraindication for administration of study drugs) currently active or clinically active in the past year; hematuria or positive stool guai ac test related to major bleeding source; and prolonged prothrombin time or partial thromboplastin time, blood urea nitrogen level higher than 40 mg / d L, serum creatinine level higher than 2.0 mg / d L (176.8 u mol / L), thrombocytopenia or neutropenia defined by the lower limit of normal for the platelet count or white blood cell count (unless absolute neutrophil count of at least 1800/mm 3), or liver function tests 2 or more times the upper limit of normal. All sites had to receive formal approval from their institutional review board before the study could commence at a local site.