A Controlled Multicenter Clinical Trial
نویسندگان
چکیده
We conducted a controlled multicenter trial with central randomization and evaluation of events under blind conditions involving 652 patients with unstable angina. Patients were treated either with conventional therapy alone (group C) (n =338) or with conventional therapy combined with an inhibitor of platelet aggregation, ticlopidine 250 mg b.i.d. (group C+T) (n=314). Patients were assigned randomly within 48 hours of admission and followed up for 6 months. With the "intention-to-treat" approach, the primary end points, vascular death and nonfatal myocardial infarction, were observed in 13.6% of the patients in group C and in 7.3% of the patients in group C+T, which is a reduction in risk of 46.3% (p=0.009). Vascular mortality was 4.7% in patients in group C and 2.5% in patients in group C+T, which is a reduction in risk of 46.8% (p=0.139). The risk of nonfatal myocardial infarction was reduced by 46.1% (p=0.039), with a frequency of 8.9o in patients in group C and 4.8% in patients in group C+T. New Q wave myocardial infarction occurred with a frequency of 6.8% in patients in group C and 3.8% in patients in group C+T, which is a reduction in risk of 44.1% (p=0.091). Fatal and nonfatal myocardial infarction was 10.91% in patients in group C and 5.1% in patients
منابع مشابه
Hemoglobin And Hematocrit Rise In End-Stage Renal Disease (ESRD) With PDpoetin: Results Of A Phase Ш, Multicenter Clinical Trial
Background and Objective: The anemia of ESRD is a complex disorder, associated with serious complications, which increases patients’ mortality and morbidity. Treatment of this anemia with recombinant human erythropoietin (rh-EPO) is well established. This clinical trial study was conducted within 20 months, from May 2005 to December 2006, in order to evaluate the efficacy of PDpoetin (rh-EPO...
متن کاملData quality assurance and quality control measures in large multicenter stroke trials: the African-American Antiplatelet Stroke Prevention Study experience
Data quality assurance and quality control are critical to the effective conduct of a clinical trial. In the present commentary, we discuss our experience in a large, multicenter stroke trial. In addition to standard data quality control techniques, we have developed novel methods to enhance the entire process. Central to our methods is the use of clinical monitors who are trained in the techni...
متن کاملLow Level Laser Therapy in Treatment of Diabetic Foot Ulcers: Double Blind Controlled Clinical Trial
متن کامل
The design and protocol of acupuncture for migraine prophylaxis: A multicenter randomized controlled trial
BACKGROUND Many studies have already reported encouraging results in the prophylactic therapy of migraine by acupuncture, but there seems to be a lack of high quality randomized controlled trials from China. We design and perform a randomized controlled clinical trial to evaluate the efficacy of acupuncture compared with flunarizine in the prophylactic therapy of patients with migraine without ...
متن کاملManagement and Conduct of Randomized Controlled Trials Knatterud Management and Conduct of Randomized Controlled Trials
“A properly planned and executed clinical trial is a powerful experimental technique for assessing the effectiveness of an intervention” (1, p. 2). This paper will discuss the issues related to the proper planning and execution of a multicenter clinical trial. The importance of a detailed protocol and manual of operations should not be underestimated. The fundamental principles are relatively s...
متن کامل