Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1) (COGENT-1)
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|ClinicalTrials.gov Identifier: NCT00557921|
Recruitment Status : Terminated (Terminated by Sponsor)
First Posted : November 14, 2007
Last Update Posted : January 28, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome Myocardial Infarction Coronary Artery Disease Percutaneous Coronary Intervention||Drug: CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin Drug: Plavix (clopidogrel 75 mg) and aspirin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Double-Dummy, Parallel Group, Phase 3 Efficacy and Safety Study of CGT-2168 Compared With Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease|
|Study Start Date :||December 2007|
|Estimated Primary Completion Date :||November 2009|
|Estimated Study Completion Date :||November 2009|
Drug: CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin
(CGT-2168 active and Comparator placebo, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)
|Active Comparator: 2||
Drug: Plavix (clopidogrel 75 mg) and aspirin
(CGT-2168 placebo and Comparator active, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)
- Composite of upper gastrointestinal clinical events, including gastroduodenal bleeding, symptomatic gastroduodenal ulcer, persistent pain with multiple gastric erosions, obstruction or perforation [ Time Frame: Anticipated minimum of 48 weeks, up to end of study ]
- Composite of gastroduodenal bleeding, symptomatic gastroduodenal ulcer, obstruction or perforation [ Time Frame: Anticipated minimum of 48 weeks, up to end of study ]
- Composite of gastroduodenal bleeding, obstruction or perforation [ Time Frame: Anticipated minimum of 48 weeks, up to end of study ]
- Discontinuation of study medication attributed to gastrointestinal signs or symptoms [ Time Frame: Anticipated minimum of 48 weeks, up to end of study ]
- Gastroesophageal reflux disease, as evidenced by symptomatic endoscopically-confirmed erosive esophagitis [ Time Frame: Anticipated minimum of 48 weeks, up to end of study ]
- Dyspepsia, defined as an increase of at least ten points on the "pain intensity" component of the SODA instrument from baseline [ Time Frame: Anticipated minimum of 48 weeks, up to end of study ]
- Occurrence of a cardiovascular event (cardiovascular death, nonfatal myocardial infarction, CABG or PCI, or confirmed ischemic stroke [ Time Frame: Anticipated minimum of 48 weeks, up to end of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00557921
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|Study Director:||Pablo Lapuerta, MD||Cogentus Pharmaceuticals|