Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1) "COGENT-1"

Terminated

Phase 3 Results N/A

Trial Description

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.

Trial Stopped: Terminated by Sponsor

Conditions

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: Antiplatelet agent
  • CGT-2168 Drug
    Intervention Desc: (clopidogrel 75 mg/omeprazole 20 mg)
  • CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin Drug
    Intervention Desc: (CGT-2168 active and Comparator placebo, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)
    ARM 1: Kind: Experimental
    Label: 1
  • Plavix (clopidogrel 75 mg) and aspirin Drug
    Intervention Desc: (CGT-2168 placebo and Comparator active, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)
    ARM 1: Kind: Experimental
    Label: 2

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to one of two arms. In the experimental arm they get either Drug: CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin or (CGT-2168 active and Comparator placebo, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician). In arm 2: they receive Active Comparator Drug: Plavix (clopidogrel 75 mg) and aspirin or (CGT-2168 placebo and Comparator active, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician). All are followed from a minimum of 48 weeks to a maximum of 96 weeks.

Outcomes

Type Measure Time Frame Safety Issue
Primary Composite of upper gastrointestinal clinical events, including gastroduodenal bleeding, symptomatic gastroduodenal ulcer, persistent pain with multiple gastric erosions, obstruction or perforation.
Secondary Composite of gastroduodenal bleeding, symptomatic gastroduodenal ulcer, obstruction or perforation; composite of gastroduodenal bleeding, obstruction or perforation; discontinuation of study medication attributed to gastrointestinal signs or symptoms; gastroesophageal reflux disease, as evidenced by symptomatic endoscopically-confirmed erosive esophagitis; dyspepsia, defined as an increase of at least ten points on the "pain intensity" component of the SODA instrument from baseline.
Primary Composite of upper gastrointestinal clinical events, including gastroduodenal bleeding, symptomatic gastroduodenal ulcer, persistent pain with multiple gastric erosions, obstruction or perforation Anticipated minimum of 48 weeks, up to end of study No
Secondary Composite of gastroduodenal bleeding, symptomatic gastroduodenal ulcer, obstruction or perforation Anticipated minimum of 48 weeks, up to end of study No
Secondary Composite of gastroduodenal bleeding, obstruction or perforation Anticipated minimum of 48 weeks, up to end of study No
Secondary Discontinuation of study medication attributed to gastrointestinal signs or symptoms Anticipated minimum of 48 weeks, up to end of study No
Secondary Gastroesophageal reflux disease, as evidenced by symptomatic endoscopically-confirmed erosive esophagitis Anticipated minimum of 48 weeks, up to end of study No
Secondary Dyspepsia, defined as an increase of at least ten points on the "pain intensity" component of the SODA instrument from baseline Anticipated minimum of 48 weeks, up to end of study No
Secondary Occurrence of a cardiovascular event (cardiovascular death, nonfatal myocardial infarction, CABG or PCI, or confirmed ischemic stroke Anticipated minimum of 48 weeks, up to end of study Yes

Sponsors