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Case study: Acute Myocardial Infarction, phase III

Left ventricular systolic dysfunction is a progressive process, which begins with injury to the myocardium. In this particular study patients have been selected who have recently suffered from acute myocardial infarction. Left ventricular systolic dysfunction is primarily a difficulty of the left ventricle to empty or eject the blood from its chamber. In the body’s efforts to compensate for this wall injury, the left ventricle wall thickens from increased impairment of myocardial contractility.

This is a phase III randomized study, which is double blind and controlled trial, is carried out in parallel groups with post myocardial infarction systolic left ventricular dysfunction. The study treatments associated for this study are two different drugs with different dosages for each one. Both of them are to be taken in combination with another drug which has a constant dosage for the two treatments.

The cumulative patient population in this study is 896 spread over 100 different sites and, the total enrollment period is 18 months with a 1 year treatment period. OCT took on the challenge on being a part of this study by contributing to the enrollment process, and site selection in 2 different countries. Russia and Ukraine are the 2 countries OCT has selected along with 18 sites and 300 patients. From this large pool of patients that OCT has contributed, 12 of the sites are located and spread throughout Russia accompanied by 247 of the patients, and of the remaining 6 sites which are located in Ukraine the remaining 57 patients are spread among sites there. Since OCT has had so much success in the past with meeting deadlines and filling patient requirements, their timeframe for enrollment was half of what the rest of the study was. Needless to say OCT met the required timeframe patient deadline within 9 months in both countries satisfying the Sponsor. Below is a graph to demonstrate at which rates OCT enrolls patients compared with the other countries involved in this particular study.

Clinical Study Enrollment in Russia, Ukraine and Other Countries

Acute Myocardial Infarction