The first patient has been enrolled in Europe in a pivotal phase III study of a combination medicine designed to reduce the side effects associated with antiplatelet therapy used to treat patients with acute coronary syndrome.
The study, at the Zadebie cardiology clinic in Skierniewice, Poland, will test the reaction of patients to the antiplatelet medicine CGT-2168. It uses a combination of clopidogrel (marketed as Plavix) and a gastroprotectant (Omeprazole) in a single pill.
Developed by Cogentus Pharmaceuticals, CGT-2168 is designed to provide cardiovascular benefits while reducing potentially serious gastrointestinal side effects commonly associated with dual antiplatelet therapy.
Antiplatelet therapy is an integral part of treating patients with acute coronary syndrome and has been shown to be effective in preventing major cardiovascular events. However, the combination of clopidogrel and aspirin is associated with gastrointestinal bleeding, which in some cases requires hospitalisation and can even result in death.
Cogentus chairman and chief executive Mark Goldsmith said that the programme had already been well received by the medical community in North America. “Now we will begin to gather important data from investigators in Europe and broaden the patient base of the study,” he added.
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