Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1)
Status:
Terminated
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
Summary
The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and
omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of
gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant
aspirin therapy.
Antiplatelet therapy is an essential element of care for patients with atherothrombotic
disease. Bleeding is a fundamental adverse effect of all antiplatelet drugs including
aspirin, clopidogrel and dual antiplatelet regimens.
The gastrointestinal tract is the most common site of bleeding related to antiplatelet
therapy, typically in connection with peptic ulcer disease. Recently published studies
suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of
aspirin or non-aspirin non-steroidal anti-inflammatory drugs. Patients taking any two of
these drugs (clopidogrel, aspirin and/or non-aspirin NSAIDs) are exposed to an even higher
risk of bleeding and ulcer disease.
Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product,
CGT-2168, which has the potential to significantly reduce this problem and increase patient
safety. CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant
(omeprazole) in a once-daily pill that may reduce the likelihood of adverse gastrointestinal
events.