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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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)
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
Secondary ID [1] 0 0
EudraCT 2007-005891-15
Secondary ID [2] 0 0
CG104
Universal Trial Number (UTN)
Trial acronym
COGENT-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Myocardial Infarction 0 0
Coronary Artery Disease 0 0
Percutaneous Coronary Intervention 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of upper gastrointestinal clinical events, including gastroduodenal bleeding, symptomatic gastroduodenal ulcer, persistent pain with multiple gastric erosions, obstruction or perforation
Timepoint [1] 0 0
Anticipated minimum of 48 weeks, up to end of study
Secondary outcome [1] 0 0
Composite of gastroduodenal bleeding, symptomatic gastroduodenal ulcer, obstruction or perforation
Timepoint [1] 0 0
Anticipated minimum of 48 weeks, up to end of study
Secondary outcome [2] 0 0
Composite of gastroduodenal bleeding, obstruction or perforation
Timepoint [2] 0 0
Anticipated minimum of 48 weeks, up to end of study
Secondary outcome [3] 0 0
Discontinuation of study medication attributed to gastrointestinal signs or symptoms
Timepoint [3] 0 0
Anticipated minimum of 48 weeks, up to end of study
Secondary outcome [4] 0 0
Gastroesophageal reflux disease, as evidenced by symptomatic endoscopically-confirmed erosive esophagitis
Timepoint [4] 0 0
Anticipated minimum of 48 weeks, up to end of study
Secondary outcome [5] 0 0
Dyspepsia, defined as an increase of at least ten points on the "pain intensity" component of the SODA instrument from baseline
Timepoint [5] 0 0
Anticipated minimum of 48 weeks, up to end of study
Secondary outcome [6] 0 0
Occurrence of a cardiovascular event (cardiovascular death, nonfatal myocardial infarction, CABG or PCI, or confirmed ischemic stroke
Timepoint [6] 0 0
Anticipated minimum of 48 weeks, up to end of study

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.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2009
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Coffs Harbour Cardiology - Coffs Harbour
Recruitment hospital [3] 0 0
Cardiac Research Institute - Eastwood
Recruitment hospital [4] 0 0
Wesley research institute - Auchenflower
Recruitment hospital [5] 0 0
Cairns Base Hospital - Cairns
Recruitment hospital [6] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [7] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [8] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [9] 0 0
Northern Hospital - Epping
Recruitment hospital [10] 0 0
St.Vincent's Hospital (Melb) - Fitzroy
Recruitment hospital [11] 0 0
Geelong Hospital- Barwon Health - Geelong
Recruitment hospital [12] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
2605 - Garran
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2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2122 - Eastwood
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
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4870 - Cairns
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
7001 - Hobart
Recruitment postcode(s) [8] 0 0
7250 - Launceston
Recruitment postcode(s) [9] 0 0
3076 - Epping
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3065 - Fitzroy
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3220 - Geelong
Recruitment postcode(s) [12] 0 0
6160 - Fremantle
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Romania
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Targu Mures
Country [198] 0 0
Romania
State/province [198] 0 0
Timisoara
Country [199] 0 0
Slovakia
State/province [199] 0 0
Banská Bystrica
Country [200] 0 0
Slovakia
State/province [200] 0 0
Bardejov
Country [201] 0 0
Slovakia
State/province [201] 0 0
Bratislava
Country [202] 0 0
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State/province [202] 0 0
Kosice
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Lucenec
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Nitra
Country [205] 0 0
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Nove Zamky
Country [206] 0 0
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Považská Bystrica
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Slovakia
State/province [207] 0 0
Trencin
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Slovakia
State/province [208] 0 0
Žilina
Country [209] 0 0
Ukraine
State/province [209] 0 0
Dnipropetrovsk
Country [210] 0 0
Ukraine
State/province [210] 0 0
Ivano-Frankivsk
Country [211] 0 0
Ukraine
State/province [211] 0 0
Kyiv
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Ukraine
State/province [212] 0 0
Zaporizhzhya
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Ukraine
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Zhytomyr

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cogentus Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00557921
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pablo Lapuerta, MD
Address 0 0
Cogentus Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00557921