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Trial record 1 of 8 for:    COGENT
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Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1) (COGENT-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00557921
Recruitment Status : Terminated (Terminated by Sponsor)
First Posted : November 14, 2007
Last Update Posted : January 28, 2009
Sponsor:
Information provided by:
Cogentus Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 12, 2007
First Posted Date  ICMJE November 14, 2007
Last Update Posted Date January 28, 2009
Study Start Date  ICMJE December 2007
Estimated Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 12, 2007)
Composite of upper gastrointestinal clinical events, including gastroduodenal bleeding, symptomatic gastroduodenal ulcer, persistent pain with multiple gastric erosions, obstruction or perforation [ Time Frame: Minimum of 48 weeks, up to 96 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2007)
  • Composite of gastroduodenal bleeding, symptomatic gastroduodenal ulcer, obstruction or perforation [ Time Frame: Minimum of 48 weeks, up to 96 weeks ]
  • Composite of gastroduodenal bleeding, obstruction or perforation [ Time Frame: Minimum of 48 weeks, up to 96 weeks ]
  • Discontinuation of study medication attributed to gastrointestinal signs or symptoms [ Time Frame: Minimum of 48 weeks, up to 96 weeks ]
  • Gastroesophageal reflux disease, as evidenced by symptomatic endoscopically-confirmed erosive esophagitis [ Time Frame: Minimum of 48 weeks, up to 96 weeks ]
  • Dyspepsia, defined as an increase of at least ten points on the "pain intensity" component of the SODA instrument from baseline [ Time Frame: Minimum of 48 weeks, up to 96 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1)
Official Title  ICMJE 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
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Coronary Syndrome
  • Myocardial Infarction
  • Coronary Artery Disease
  • Percutaneous Coronary Intervention
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin
  • Active Comparator: 2
    Intervention: Drug: Plavix (clopidogrel 75 mg) and aspirin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: November 13, 2008)
5000
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2007)
3200
Estimated Study Completion Date  ICMJE November 2009
Estimated Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients in whom a requirement for clopidogrel therapy with concomitant aspirin is anticipated for at least the next 12 months. Specific conditions that may confer a need for long-term clopidogrel + aspirin therapy may include non-ST segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI), ST segment elevation acute MI), or new placement of a coronary artery stent.
  • For women of childbearing potential, negative pregnancy test prior to randomization and agreement to use effective method of birth control during the study.
  • Able to provide written informed consent based on competent mental status.

Exclusion Criteria:

  • Patients currently hospitalized for whom discharge is not anticipated within 48 hours of randomization.
  • Requirement for current or chronic use of a proton pump inhibitor, H2 receptor blocker, sucralfate or misoprostol.
  • Erosive esophagitis, esophageal or gastric variceal disease, or non-endoscopic gastric surgery. Patients with a history of GERD/erosive esophagitis or dyspepsia who do not currently require proton pump blockers will be eligible.
  • Receipt of > 21 days of clopidogrel or another thienopyridine prior to randomization.
  • Oral anticoagulation that cannot be safely discontinued for duration of study.
  • Recent fibrinolytic therapy.
  • Scheduled percutaneous coronary intervention (PCI). Patients may be enrolled upon completion of PCI.
  • Recent (< 30 days prior to randomization) or scheduled coronary artery bypass graft (CABG) surgery.
  • Cardiogenic shock at time of randomization, refractory ventricular arrhythmias, or congestive heart failure (NY Heart Association class IV).
  • Active pathological bleeding or a history of hereditary or acquired hemostatic disorder.
  • History of hemorrhagic stroke, intracranial neoplasm, arteriovenous malformation or aneurysm.
  • Systemic corticosteroids except low-dose oral corticosteroids equivalent to prednisone < or equal to 5 mg/day.
  • Allergy or contraindication to clopidogrel or other thienopyridine drugs, omeprazole or other proton pump inhibitor drugs, aspirin or salicylate derivatives, or other study drug ingredients.
  • Treatment within 30 days prior to randomization with any investigational drug or device including investigational coronary artery stents or currently enrolled in another interventional drug or device study.
  • Women who are pregnant or breastfeeding.
  • Life expectancy less than 12 months.
  • Laboratory abnormality at screening that is clinically significant or outside protocol-allowed limits, or any other condition that precludes participation in the study in the opinion of the Investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bulgaria,   Canada,   Chile,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Mexico,   Poland,   Puerto Rico,   Romania,   Slovakia,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00557921
Other Study ID Numbers  ICMJE CG104
EudraCT 2007-005891-15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pablo Lapuerta, MD, Cogentus Pharmaceuticals
Study Sponsor  ICMJE Cogentus Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pablo Lapuerta, MD Cogentus Pharmaceuticals
PRS Account Cogentus Pharmaceuticals
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP