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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00557921
Registration number
NCT00557921
Ethics application status
Date submitted
12/11/2007
Date registered
14/11/2007
Date last updated
28/01/2009
Titles & IDs
Public title
Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1)
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Scientific 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
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Secondary ID [1]
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EudraCT 2007-005891-15
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Secondary ID [2]
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CG104
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Universal Trial Number (UTN)
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Trial acronym
COGENT-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome
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Myocardial Infarction
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Coronary Artery Disease
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Percutaneous Coronary Intervention
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Condition category
Condition code
Cardiovascular
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0
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Coronary heart disease
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Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin
Treatment: Drugs - Plavix (clopidogrel 75 mg) and aspirin
Experimental: 1 -
Active comparator: 2 -
Treatment: Drugs: 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)
Treatment: Drugs: 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)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Composite of upper gastrointestinal clinical events, including gastroduodenal bleeding, symptomatic gastroduodenal ulcer, persistent pain with multiple gastric erosions, obstruction or perforation
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Assessment method [1]
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Timepoint [1]
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Anticipated minimum of 48 weeks, up to end of study
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Secondary outcome [1]
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Composite of gastroduodenal bleeding, symptomatic gastroduodenal ulcer, obstruction or perforation
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Assessment method [1]
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0
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Timepoint [1]
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Anticipated minimum of 48 weeks, up to end of study
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Secondary outcome [2]
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Composite of gastroduodenal bleeding, obstruction or perforation
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Assessment method [2]
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Timepoint [2]
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Anticipated minimum of 48 weeks, up to end of study
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Secondary outcome [3]
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Discontinuation of study medication attributed to gastrointestinal signs or symptoms
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Assessment method [3]
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Timepoint [3]
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Anticipated minimum of 48 weeks, up to end of study
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Secondary outcome [4]
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Gastroesophageal reflux disease, as evidenced by symptomatic endoscopically-confirmed erosive esophagitis
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Assessment method [4]
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Timepoint [4]
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Anticipated minimum of 48 weeks, up to end of study
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Secondary outcome [5]
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Dyspepsia, defined as an increase of at least ten points on the "pain intensity" component of the SODA instrument from baseline
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Assessment method [5]
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Timepoint [5]
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Anticipated minimum of 48 weeks, up to end of study
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Secondary outcome [6]
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Occurrence of a cardiovascular event (cardiovascular death, nonfatal myocardial infarction, CABG or PCI, or confirmed ischemic stroke
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Assessment method [6]
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Timepoint [6]
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Anticipated minimum of 48 weeks, up to end of study
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Eligibility
Key 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.
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Minimum age
21
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/11/2009
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Actual
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Sample size
Target
5000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC,WA
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Recruitment hospital [1]
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The Canberra Hospital - Garran
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Coffs Harbour Cardiology - Coffs Harbour
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Cardiac Research Institute - Eastwood
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Wesley research institute - Auchenflower
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Cairns Base Hospital - Cairns
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Royal Brisbane and Women's Hospital - Herston
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Royal Hobart Hospital - Hobart
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Launceston General Hospital - Launceston
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Northern Hospital - Epping
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Geelong Hospital- Barwon Health - Geelong
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Fremantle Hospital - Fremantle
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2605 - Garran
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2450 - Coffs Harbour
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2122 - Eastwood
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4066 - Auchenflower
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4870 - Cairns
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4029 - Herston
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7001 - Hobart
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7250 - Launceston
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3076 - Epping
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3065 - Fitzroy
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3220 - Geelong
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6160 - Fremantle
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Recruitment outside Australia
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Limanowa
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Mielec
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Kyiv
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Funding & Sponsors
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Commercial sector/industry
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Name
Cogentus Pharmaceuticals
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00557921
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Trial related presentations / publications
Vaduganathan M, Bhatt DL, Cryer BL, Liu Y, Hsieh WH, Doros G, Cohen M, Lanas A, Schnitzer TJ, Shook TL, Lapuerta P, Goldsmith MA, Laine L, Cannon CP; COGENT Investigators. Proton-Pump Inhibitors Reduce Gastrointestinal Events Regardless of Aspirin Dose in Patients Requiring Dual Antiplatelet Therapy. J Am Coll Cardiol. 2016 Apr 12;67(14):1661-71. doi: 10.1016/j.jacc.2015.12.068. Epub 2016 Mar 21. Bhatt DL, Cryer BL, Contant CF, Cohen M, Lanas A, Schnitzer TJ, Shook TL, Lapuerta P, Goldsmith MA, Laine L, Scirica BM, Murphy SA, Cannon CP; COGENT Investigators. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med. 2010 Nov 11;363(20):1909-17. doi: 10.1056/NEJMoa1007964. Epub 2010 Oct 6.
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Public notes
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Contacts
Principal investigator
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Pablo Lapuerta, MD
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Cogentus Pharmaceuticals
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https://clinicaltrials.gov/study/NCT00557921
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