Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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)
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
Stopped early
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
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2122 - Eastwood
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
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
Recruitment postcode(s) [10] 0 0
3065 - Fitzroy
Recruitment postcode(s) [11] 0 0
3220 - Geelong
Recruitment postcode(s) [12] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Iowa
Country [14] 0 0
United States of America
State/province [14] 0 0
Kansas
Country [15] 0 0
United States of America
State/province [15] 0 0
Kentucky
Country [16] 0 0
United States of America
State/province [16] 0 0
Louisiana
Country [17] 0 0
United States of America
State/province [17] 0 0
Maine
Country [18] 0 0
United States of America
State/province [18] 0 0
Maryland
Country [19] 0 0
United States of America
State/province [19] 0 0
Massachusetts
Country [20] 0 0
United States of America
State/province [20] 0 0
Michigan
Country [21] 0 0
United States of America
State/province [21] 0 0
Minnesota
Country [22] 0 0
United States of America
State/province [22] 0 0
Mississippi
Country [23] 0 0
United States of America
State/province [23] 0 0
Missouri
Country [24] 0 0
United States of America
State/province [24] 0 0
Montana
Country [25] 0 0
United States of America
State/province [25] 0 0
Nebraska
Country [26] 0 0
United States of America
State/province [26] 0 0
Nevada
Country [27] 0 0
United States of America
State/province [27] 0 0
New Hampshire
Country [28] 0 0
United States of America
State/province [28] 0 0
New Jersey
Country [29] 0 0
United States of America
State/province [29] 0 0
New York
Country [30] 0 0
United States of America
State/province [30] 0 0
North Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
North Dakota
Country [32] 0 0
United States of America
State/province [32] 0 0
Ohio
Country [33] 0 0
United States of America
State/province [33] 0 0
Oklahoma
Country [34] 0 0
United States of America
State/province [34] 0 0
Oregon
Country [35] 0 0
United States of America
State/province [35] 0 0
Pennsylvania
Country [36] 0 0
United States of America
State/province [36] 0 0
Rhode Island
Country [37] 0 0
United States of America
State/province [37] 0 0
South Carolina
Country [38] 0 0
United States of America
State/province [38] 0 0
Tennessee
Country [39] 0 0
United States of America
State/province [39] 0 0
Texas
Country [40] 0 0
United States of America
State/province [40] 0 0
Virginia
Country [41] 0 0
United States of America
State/province [41] 0 0
Washington
Country [42] 0 0
United States of America
State/province [42] 0 0
West Virginia
Country [43] 0 0
United States of America
State/province [43] 0 0
Wisconsin
Country [44] 0 0
Bulgaria
State/province [44] 0 0
Dimitrovgrad
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Pleven
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Plovdiv
Country [47] 0 0
Bulgaria
State/province [47] 0 0
Rousse
Country [48] 0 0
Bulgaria
State/province [48] 0 0
Sofia
Country [49] 0 0
Bulgaria
State/province [49] 0 0
Varna
Country [50] 0 0
Canada
State/province [50] 0 0
British Columbia
Country [51] 0 0
Canada
State/province [51] 0 0
Manitoba
Country [52] 0 0
Canada
State/province [52] 0 0
New Brunswick
Country [53] 0 0
Canada
State/province [53] 0 0
Newfoundland and Labrador
Country [54] 0 0
Canada
State/province [54] 0 0
Ontario
Country [55] 0 0
Canada
State/province [55] 0 0
Quebec
Country [56] 0 0
Chile
State/province [56] 0 0
Antofagasta
Country [57] 0 0
Chile
State/province [57] 0 0
Osorno
Country [58] 0 0
Chile
State/province [58] 0 0
Punta Arenas
Country [59] 0 0
Chile
State/province [59] 0 0
Santiago
Country [60] 0 0
Chile
State/province [60] 0 0
Temuco
Country [61] 0 0
Chile
State/province [61] 0 0
Viña del Mar
Country [62] 0 0
Czech Republic
State/province [62] 0 0
Frydek-Mistek
Country [63] 0 0
Czech Republic
State/province [63] 0 0
Hradec Kralove
Country [64] 0 0
Czech Republic
State/province [64] 0 0
Liberec
Country [65] 0 0
Czech Republic
State/province [65] 0 0
Litomysl
Country [66] 0 0
Czech Republic
State/province [66] 0 0
Ostrava Vítkovice
Country [67] 0 0
Czech Republic
State/province [67] 0 0
Ostrava
Country [68] 0 0
Czech Republic
State/province [68] 0 0
Pardubice
Country [69] 0 0
Czech Republic
State/province [69] 0 0
Praha 2
Country [70] 0 0
Czech Republic
State/province [70] 0 0
Praha 4
Country [71] 0 0
Czech Republic
State/province [71] 0 0
Zlín
Country [72] 0 0
Czech Republic
State/province [72] 0 0
Znojmo
Country [73] 0 0
France
State/province [73] 0 0
Albi
Country [74] 0 0
France
State/province [74] 0 0
Dijon Cedex
Country [75] 0 0
France
State/province [75] 0 0
Essey les Nancy Cedex
Country [76] 0 0
France
State/province [76] 0 0
Lille Cedex
Country [77] 0 0
France
State/province [77] 0 0
Marseille
Country [78] 0 0
France
State/province [78] 0 0
Paris Cedex 13
Country [79] 0 0
France
State/province [79] 0 0
Paris
Country [80] 0 0
France
State/province [80] 0 0
St Jean de Verges
Country [81] 0 0
France
State/province [81] 0 0
Toulouse Cedex 4
Country [82] 0 0
Germany
State/province [82] 0 0
Berlin
Country [83] 0 0
Germany
State/province [83] 0 0
Biberach
Country [84] 0 0
Germany
State/province [84] 0 0
Bochum
Country [85] 0 0
Germany
State/province [85] 0 0
Bonn-Lengsdorf
Country [86] 0 0
Germany
State/province [86] 0 0
Bonn
Country [87] 0 0
Germany
State/province [87] 0 0
Brandenburg
Country [88] 0 0
Germany
State/province [88] 0 0
Chemnitz
Country [89] 0 0
Germany
State/province [89] 0 0
Dinslaken
Country [90] 0 0
Germany
State/province [90] 0 0
Dortmund
Country [91] 0 0
Germany
State/province [91] 0 0
Dresden
Country [92] 0 0
Germany
State/province [92] 0 0
Erfurt
Country [93] 0 0
Germany
State/province [93] 0 0
Essen
Country [94] 0 0
Germany
State/province [94] 0 0
Hamburg
Country [95] 0 0
Germany
State/province [95] 0 0
Hannover
Country [96] 0 0
Germany
State/province [96] 0 0
Hartmannsdorf
Country [97] 0 0
Germany
State/province [97] 0 0
Karlsbad
Country [98] 0 0
Germany
State/province [98] 0 0
Koln
Country [99] 0 0
Germany
State/province [99] 0 0
Lahr
Country [100] 0 0
Germany
State/province [100] 0 0
Leipzig
Country [101] 0 0
Germany
State/province [101] 0 0
Ludwigshafen
Country [102] 0 0
Germany
State/province [102] 0 0
Lübeck
Country [103] 0 0
Germany
State/province [103] 0 0
Lüneburg
Country [104] 0 0
Germany
State/province [104] 0 0
Mainz
Country [105] 0 0
Germany
State/province [105] 0 0
Mannheim
Country [106] 0 0
Germany
State/province [106] 0 0
Markkleeberg
Country [107] 0 0
Germany
State/province [107] 0 0
Melsungen
Country [108] 0 0
Germany
State/province [108] 0 0
Mönchengladbach
Country [109] 0 0
Germany
State/province [109] 0 0
Mühldorf a.d. Inn
Country [110] 0 0
Germany
State/province [110] 0 0
Nienburg
Country [111] 0 0
Germany
State/province [111] 0 0
Pirna
Country [112] 0 0
Germany
State/province [112] 0 0
Regensburg
Country [113] 0 0
Germany
State/province [113] 0 0
Reinbek
Country [114] 0 0
Germany
State/province [114] 0 0
Riesa
Country [115] 0 0
Germany
State/province [115] 0 0
Rottweil
Country [116] 0 0
Germany
State/province [116] 0 0
Siegen
Country [117] 0 0
Germany
State/province [117] 0 0
Soest
Country [118] 0 0
Germany
State/province [118] 0 0
Stuhr
Country [119] 0 0
Germany
State/province [119] 0 0
Tubingen
Country [120] 0 0
Germany
State/province [120] 0 0
Warendorf
Country [121] 0 0
Germany
State/province [121] 0 0
Wermsdorf
Country [122] 0 0
Germany
State/province [122] 0 0
Weyhe-Leeste
Country [123] 0 0
Germany
State/province [123] 0 0
Witten
Country [124] 0 0
Germany
State/province [124] 0 0
Wuppertal
Country [125] 0 0
Hungary
State/province [125] 0 0
Baja
Country [126] 0 0
Hungary
State/province [126] 0 0
Budapest
Country [127] 0 0
Hungary
State/province [127] 0 0
Kalocsa
Country [128] 0 0
Hungary
State/province [128] 0 0
Nyíregyháza
Country [129] 0 0
Hungary
State/province [129] 0 0
Toszegi
Country [130] 0 0
Hungary
State/province [130] 0 0
Vác
Country [131] 0 0
Hungary
State/province [131] 0 0
Zalaegerszeg
Country [132] 0 0
Italy
State/province [132] 0 0
Bergamo
Country [133] 0 0
Italy
State/province [133] 0 0
Codogno (Lodi)
Country [134] 0 0
Italy
State/province [134] 0 0
Genova
Country [135] 0 0
Italy
State/province [135] 0 0
Mantova
Country [136] 0 0
Italy
State/province [136] 0 0
Novara
Country [137] 0 0
Italy
State/province [137] 0 0
Rozzano (Milano)
Country [138] 0 0
Mexico
State/province [138] 0 0
Jalisco
Country [139] 0 0
Mexico
State/province [139] 0 0
San Lusi Potosi
Country [140] 0 0
Mexico
State/province [140] 0 0
Aguascalientes
Country [141] 0 0
Mexico
State/province [141] 0 0
D. F.
Country [142] 0 0
Mexico
State/province [142] 0 0
Durango
Country [143] 0 0
Mexico
State/province [143] 0 0
Puebla
Country [144] 0 0
Mexico
State/province [144] 0 0
Queretaro
Country [145] 0 0
Mexico
State/province [145] 0 0
San Luis Potosi
Country [146] 0 0
Poland
State/province [146] 0 0
Bydgoszcz
Country [147] 0 0
Poland
State/province [147] 0 0
Debica
Country [148] 0 0
Poland
State/province [148] 0 0
Gdansk
Country [149] 0 0
Poland
State/province [149] 0 0
Gdynia
Country [150] 0 0
Poland
State/province [150] 0 0
Gliwice
Country [151] 0 0
Poland
State/province [151] 0 0
Grodzisk Mazowiecki
Country [152] 0 0
Poland
State/province [152] 0 0
Inowroclaw
Country [153] 0 0
Poland
State/province [153] 0 0
Katowice
Country [154] 0 0
Poland
State/province [154] 0 0
Koscierzyna
Country [155] 0 0
Poland
State/province [155] 0 0
Krakow
Country [156] 0 0
Poland
State/province [156] 0 0
Kraków
Country [157] 0 0
Poland
State/province [157] 0 0
Kutno
Country [158] 0 0
Poland
State/province [158] 0 0
Limanowa
Country [159] 0 0
Poland
State/province [159] 0 0
Lubartów
Country [160] 0 0
Poland
State/province [160] 0 0
Mielec
Country [161] 0 0
Poland
State/province [161] 0 0
Nowa Sól
Country [162] 0 0
Poland
State/province [162] 0 0
Olawa
Country [163] 0 0
Poland
State/province [163] 0 0
Olsztyn
Country [164] 0 0
Poland
State/province [164] 0 0
Opole
Country [165] 0 0
Poland
State/province [165] 0 0
Ostrów Wielkopolski
Country [166] 0 0
Poland
State/province [166] 0 0
Pabianice
Country [167] 0 0
Poland
State/province [167] 0 0
Piotrków Trybunalski
Country [168] 0 0
Poland
State/province [168] 0 0
Poznan
Country [169] 0 0
Poland
State/province [169] 0 0
Pruszków
Country [170] 0 0
Poland
State/province [170] 0 0
Pulawy
Country [171] 0 0
Poland
State/province [171] 0 0
Plock
Country [172] 0 0
Poland
State/province [172] 0 0
Radom
Country [173] 0 0
Poland
State/province [173] 0 0
Rzeszów
Country [174] 0 0
Poland
State/province [174] 0 0
Sandomierz
Country [175] 0 0
Poland
State/province [175] 0 0
Siedlce
Country [176] 0 0
Poland
State/province [176] 0 0
Sieradz
Country [177] 0 0
Poland
State/province [177] 0 0
Skierniewice
Country [178] 0 0
Poland
State/province [178] 0 0
Stalowa Wola
Country [179] 0 0
Poland
State/province [179] 0 0
Starogard Gdanski
Country [180] 0 0
Poland
State/province [180] 0 0
Szczecin
Country [181] 0 0
Poland
State/province [181] 0 0
Tarnów
Country [182] 0 0
Poland
State/province [182] 0 0
Torun
Country [183] 0 0
Poland
State/province [183] 0 0
Warszawa
Country [184] 0 0
Poland
State/province [184] 0 0
Walbrzych
Country [185] 0 0
Poland
State/province [185] 0 0
Wroclaw
Country [186] 0 0
Poland
State/province [186] 0 0
Zabrze
Country [187] 0 0
Poland
State/province [187] 0 0
Lomza
Country [188] 0 0
Poland
State/province [188] 0 0
Lódz
Country [189] 0 0
Puerto Rico
State/province [189] 0 0
Ponce
Country [190] 0 0
Romania
State/province [190] 0 0
Bacau
Country [191] 0 0
Romania
State/province [191] 0 0
Bucharest
Country [192] 0 0
Romania
State/province [192] 0 0
Bucuresti
Country [193] 0 0
Romania
State/province [193] 0 0
Cluj-Napoca
Country [194] 0 0
Romania
State/province [194] 0 0
Craiova
Country [195] 0 0
Romania
State/province [195] 0 0
Iasi
Country [196] 0 0
Romania
State/province [196] 0 0
Sibiu
Country [197] 0 0
Romania
State/province [197] 0 0
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
Slovakia
State/province [202] 0 0
Kosice
Country [203] 0 0
Slovakia
State/province [203] 0 0
Lucenec
Country [204] 0 0
Slovakia
State/province [204] 0 0
Nitra
Country [205] 0 0
Slovakia
State/province [205] 0 0
Nove Zamky
Country [206] 0 0
Slovakia
State/province [206] 0 0
Považská Bystrica
Country [207] 0 0
Slovakia
State/province [207] 0 0
Trencin
Country [208] 0 0
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
Country [212] 0 0
Ukraine
State/province [212] 0 0
Zaporizhzhya
Country [213] 0 0
Ukraine
State/province [213] 0 0
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/study/NCT00557921
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.
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/study/NCT00557921