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

Primary Purpose

Acute Coronary Syndrome, Myocardial Infarction, Coronary Artery Disease

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin

Plavix (clopidogrel 75 mg) and aspirin

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring ACS, CAD, MI, PCI, PTCA, NSTEMI, STEMI, acute coronary syndrome, cerebrovascular disorders, coronary artery stent placement, coronary thrombosis, myocardial infarction, myocardial ischemia, percutaneous coronary intervention, percutaneous transluminal coronary angioplasty, peripheral vascular diseases, duodenal obstruction, duodenal ulcer, dyspepsia, esophagitis, peptic, gastric outlet obstruction, gastroduodenal ulcer, gastroesophageal reflux disease, gastrointestinal hemorrhage, peptic ulcer, peptic ulcer perforation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Alabama Clinical Research Institute, Inc. (ACRI)
Alabama Clinical Therapeutics, LLC
Cardio-Thoracic Surgeons P.C.
Birmingham Heart Clinic, PC
John F Simmons , MD PC
Clinical Research Consultants, Inc.
The Heart Center, PC
Mobile Heart Specialists, PC
Advanced Cardiac Specialists
Redpoint Research
Cardiovascular Consultants, Ltd.
Cochise Clinical Research
Paradigm Clinical Research, Inc.
Tri-Lakes Research
Michael A. Frais, Cardiologist, P.A.
NEA-Clinic Cardiology
Searcy Medical Center
Cardiology Consultants of Orange County
Chest and Critical Care Consultants, A Medical Group
Clinical Solutions Advantage
Turns Institute for Clinical Research
Escondido Cardiology Associates
Accurate Clinical Trials, Inc.
Therapeutic Research Institute of Orange County
Kirtik Thaker MD
Los Angeles Cardiology Associates
Merced Heart Associates
Mission Internal Medical Group
Altos Cardiovascular Associates
Kenneth W. Carr, MD, Cardiology
Rancho CucamongaClinical Trials
Inland Heart and Vascular Medical Associates
Ritchken and First
Rider Research Group
Richard Levy, MD.
Kaiser Permanente
Medical Helping Hands Research
Pacific Heart Institute
Radiant Research
Harbor- UCLA Medical Center
Ventura Cardiology Consultants Medical Group, Inc.
Colorado Springs Health Partners
Connecticut Clinical Research
Hartford Hospital
Alfieri Cardiology, PA
Washington V.A. Medical Center
Oscar R. Guerra, MD PA
Deerfield Beach Cardiology Associates
Dr Jules Cohen
Empire International Research
Cardiovascular Consultants of South Florida
Jacksonville Heart Center
Jacksonville Center for Clinical Research
Jacksonville Heart Center
CVMS Resesarch Institute, LLC
Watson Clinic Center for Research
Alpha Medical Research, LLC
Empire International Research
Suncoast Research Group, LLC
Cardiovascular Research Center of South Florida
Research Center Phase I-IV of Florida Corp.
Empire International Research
Bert Fish Medical Center
Central Florida Cardiology Group
Cardiology Assocaites of Orlando d/b/a Orlando Heart Center
Sunset Point Medical Associates
Berma Research Group
Charlotte Heart Group Research Center
Suncoast Cardiovascular Research
The Heart and Vascular Institute of Florida
G&G Research Baker-Tombul Cardiology
Carlos Levy, D.O.
Piedmont Hospital
Primary Care Specialists, LLC/ ECAST CT
Executive Health and Research Associates, Inc.
Southeast Regional Research Group
Georgia Heart Specialists, LLC
Ialum Clinical Research Center, LLC
Ialum Clinical Research Center
Ialum Clinical Research Center
Southeast Regional Research Group
Medsouth Primary CareStockbridge
South Suburban Health Professional Group, PC
Consultants in Cardiovascular Medicine
Methodist Medical Center of Illinois
Community Clinical Research Center
American Health Network
Indiana Medical Research
Welborn Clinic
Indiana Heart Physicians
Midwest Cardiovascular Research Foundation
Northeast Iowa Medical Education Foundation
Hutchinson Clinic, P.A.
Venture Resource Group, Inc.
Midwest Cardiology Assocaites
Cumberland Cardiology
Trover Health System
Owensboro Heart and Vascular
Dolby Research, LLC
Cardiovascular Institute of the South
Heart Clinic of Louisiana Clinical Research, LLC.
Maine Research Associates
Cardiovascular Consultants of Maine, PA
Maine Cardiology Associates
Good Samaritan Hospital (Medstar Health)
eCast Corporation
Atlantic Cardiology Associates, P.A
Peninsula Cardiology Associates
Pentucket Medical Associates
Charles River Medical Associates
Michigan Cardiovascular Institute
Apex Medical Research, AMR, Inc.
Borgess Research Institute
Michigan Cardiovascular Institute
Michigan Cardiovascular Institute
Covenant Medical Center, Inc.
Academic Heart and Vascular PLLC
Oakland Medical Center
Waterford Medical Assoc. P.C.
Michigan Heart, PC
Duluth Clinic / Saint Marys Medical Center
University of Minnesota
Regions Hospital
New Coast Cardiology Center, PLLC
PPS Clinical Research, STL, LLC
Kansas City VA Medical Center
Cardiology Diagnostics, Ltd.
Glacier View Cardiology
Saint Patrick Hospital- International Heart Institute of Montana
The Creighton Cardiac Center
Alegent Health Clinic Heart and Vascular Specialist
Nevada Cardiology Associates
Lahey Cardiology @ the Medical Center
Associated Cardiovascular Consultants
Cardiovascular Associates of the Delaware Valley, P.A.
Cardiovascular Associates of the Delaware Valley, P.A.
Cardiovascular Associates of the Delaware Valley, P.A.
Physicans Research Center, LLC
Capital Cardiology Associates
Cardiac Care and Vascular Medicine, Albert Einstein College of Medicine
Hudson Valley Cardiology Group, P.C.
Cardiology Associates, P.C.
Long Island Heart Associates
Slocum-Dickson Medical Group, PLLC
Sound Shore Cardiology, P.C.
New York Cardiovascular Associate
St. Luke's- Roosevelt Hospital
Rochester General Hospital
Saratoga Cardiology Assoc, PC
Westchester Cardiology Associates
Good Samaritan Hospital
Cardiology, PC
SUNY Upstate Medical University
Capital Cardiology Associates
Buffalo Cardiology and Pulmonary Associates
Mark J. Kozinn, MD
Clinical Study Center of Asheville, LLC
Kernodle Clinic, Inc.
Metrolina Medical Research
Diversified Research
Cumberland Research Associates, LLC
Cardiovascular Care of Northern Carolina
St. Alexius Medical Center
Altru Health Systems
Trinity Health
George G. Ellis, Jr. M.D., Inc.
Cardiovascular Research Institute, LLC
Comprehensive Cardiology Consultants, Inc.
Midwest Cardiology Research Foundation
Prestige Clinical Research
St. Vincent Mercy Medical Center
Cardiology Associates of SE Ohio, Inc
Physicans Research, Inc.
Bluestem Cardiology Research Dept.
Oklahoma Cardiovascular Research Group
Aquilo Research
Bend Memorial Clinic
Hillsboro Cardiology, PC
Legacy Clinical Research
Abington Medical Specialists
Tri-State Medical Group
Heritage Cardiology Association
Premier Heart Specialists
Heart Specialists of Lancaster
Penn State Hershey Medical Center
Pennsylvania Heart and Vascular Group, P.C.
Comprehensive Cardiology Consultants
Sewickley Valley Medical Group Cardiology
Cardiology Consultants of Philadelphia
Hospital of the University of Pennsylvania Cardiology Department
Cardiology Consultants of Philadelphia
Albert Einstein Medical Center
Cardiology Consultants of Philadelphia
VA Pittsburgh Healthcare System
Advanced Cardiology Specialists
Elite Medical Research, Inc.
Cardiology Consultants of Philadelphia
West Chester Cardiology, PC
Berks Cardiology, Ltd.
Cardiology Consultants of Philadelphia
New England Center for Clinical Research, Inc
Rhode Island Hospital Cardiology
Cardiology Specialists
Palmetto Clinical Research
McMinn Medical Group (DBA: Athens Medical Group)
Verzosa & Ungab Internal Medicine Associates
Middle Tennessee Clinical Research
Research Associates of Jackson and Apex Cardiology
Tri-State Cardiology
Memphis Internal Medicine
Goodlife Medical Center
Heart and Vascular Clinic
Family Health Care Assoc.
Southeast Texas Clinical Research Center
Trinity Hypertension and Diagnostic Res.
VA Medical Center
U.T. Southwestern
Amir Malik Research
The University of Texas Medical Branch at Galveston
East Texas Cardiology PA
Office of Amer Zaheer, MD
Office of Salim Gopalani, MD
Comprehensive Heart Care, PA
Century Clinical Research
Office of Mizra Basith Baig, MD
Covenant Cardiology Associates
South Texas Institutes of Health
Texas Regional Heart Center d/b/a Legacy Heart Center
Heart & Vascular Institute of Texas
Cardiology Clinic of San Antonio
South Texas Cardiovascular Consultants
IMED Research, PA
Southwest Health Associate, PA
Office of Dwayne O. Williams, MD
Kings Daughters Clinic
Victoria Heart and Vascular Center
Cardiology Consultants of Danville
Triad Research Institute
Virginia Cardiovascular Specialists
Winchester Medical Center/ Clinical Research Department
Daniel W. Gottlieb, MD, PS
Heart Clinic Northwest
Inland Cardiology Assocaites
Franciscan Health System dba FHS Research Center
Parkersburg Cardiology Associates
Wisconsin Heart, S.C.
Heart Care Associates, LLC
The Canberra Hospital
Coffs Harbour Cardiology
Cardiac Research Institute
Wesley research institute
Cairns Base Hospital
Royal Brisbane and Women's Hospital
Royal Hobart Hospital
Launceston General Hospital
Northern Hospital
St.Vincent's Hospital (Melb)
Geelong Hospital- Barwon Health
Fremantle Hospital
Multiprofile Hospital for Active Treatment "Sveta Ekaterina", 1st Department of Internal Diseases
Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski, Clinic of Cardiology
Multiprofile Hospital for Active Treatment ''Sveti Georgi'', Cardiology Clinic
Multiprofile Hospital for Active Treatment ''Sveti Panteleymon'', 2nd Department. of Internal Diseases - Intensive Cardiology Unit
Multiprofile Hospital for Active Treatment - Ruse, 4th Department of Internal Diseases
4th Multiprofile Hospital for Active Treatment
Military Medical Academy, Clinic of Cardiology and Intensive Care
Multiprofile Hospital for Active Treatment and Emergency Medicine "Pirogov". Cardiology Clinic
National Heart Hospital Department of Cardiology
National Multiprofile Transport Hospital "Tsar Boris III, Cardiology Clinic
Tokuda Hospital Department of Cardiology
University Multiprofile Hospital for Active Treatment ''Tsaritsa Ioanna'' - ISUL, Cardiology Clinic
Multiprofile Hospital for Active Treatment "Sveta Marina", Clinic of Internal Diseases - 2nd Internal Department
Dr. Tsui
Fraser Clinical Trials Inc and Royal Columbian Hospital
Vancouver General Hospital
Victoria Heart Institute Foundation
Health Sciences Centre
South East Regional Health Authority
Commonwealth Medical Clinic
Cambridge Cardiac Care Centre
Mississauga Clinical Research Center
Dr. George Zimakas
Dr. James Y. Cha
Curans Health Center
Toronto East Cardiology Associates Inc.
Recherches Cliniques Theradev
ViaCar Recherche Clinique Inc.
ViaCar Recherche Clinique Inc
Hospitalier de l'Universite de Montreal Hotel Dieu
Sacre-Coeur Hospital
Centre de Sante et de services sociaux du nord de lanaudiere/CHRDL
Centre Hospitalier Beauce-Etchemin
Clinique de Cardiologie de Trois-Rivieres
Cardiology and Research
Centre Hospitalier Universitaire de Quebec (CHOQ) Hotel Dieu de Quebec
Laval Hospital
Clinica Antofagasta
Corporación de Beneficencia Osorno
Hospital Regional de Punta Arenas Dr. Lautaro Navarro
Complejo Asistencial Dr.Sótero del Río
Hospital del Salvador
Instituto Nacional del Tórax
Centro de Estudios Cardiovascular
Clínica Reñaca
Hospital Dr. Gustavo Fricke
Hospital Naval Almirante Neff
Nemocnice ve Frydku-Mistku
Fakultni nemocnice Hradec Kralove
Krajska nemocnice Liberec, a. s.
Litomyslska nemocnice a. s.
Kardiologicka a angiologicka ambulance
Kardiologická ambulance
Pardubicka krajska nemocnice, a.s.
II.interni klinika kardiologie a angiologie 1. LF UK a VFN v Praze
Klinika kardiologie Institut klinické a experimentální medicíny
Krajská nemocnice T. Bati a.s.
Nemocnice Znojmo, p.o.
Centre Hospitalier d'Albi
Centre de Cardiologie CHRU Dijon
Clinique Pasteur
CHRU de Lille Hôpital Cardiologique
Hôpital La Timone-Adultes
La Pitié Salpétrière Institut de Cardiologie
Hôpital Lariboisière
Centre Hospitalier Intercommunal du Val d'Ariège
Centre Hospitalier Rangueil Larrey
Universitatsklinikum Berlin Campus Charite Mitte Med Klinik Kardiologie und Angiologie
Vivantes Clinic Neuköln Berlin
Vivantes Humbolt Klinikum
Praxis Dr. med. Boscher
St. Josef-Hospital Medizinische Klinik II, Kardiologie
Dr. THomas Klingenheben
St.-Marien-Hospital Bonn
Städtisches Klinikum Brandenburg GmbH
MVZ am Küchwald GmbH
Gemeinschaftspraxis Innere Medizin und Kardiologie
St.-Johannes-Hospital Dortmund
Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR
Practice of Cardiology
Elisabeth.Krankenhaus
Asklepios Klinik St.Georg
Asklepios Klinik Barmbek
Universitäres Herz-und Gefäßzentrum Hamburg"
Kardiologische Praxis Hamburg Altona
Klinikum Region Hannover Krankenhaus Nordstadt
Kardiologische Gemeinschaftspraxis
SRH Klinikum Karlsbad-Langensteinbach
Kliniken der Stadt Köln, Köln Merheim
Herzzentrum Lahr
Kardiologische Gemeinschaftpraxis
Universität Leipzig - Herzzentrum
Praxis für Innere Medizin, Gastroenterologie
Universitätsklinikum Lübeck
Gemeinschaftspraxis
Klinikum der Johannes-Gutenberg-Universität
Gemeinschaftspraxis
Klinikum Mannheim GmbH, Universaitatskinikum
Kardiologische Praxis
Asklepios Klinik Melsungen
Kilniken Maria Hilf GmbH Krankenhaus St. Franziskus
Internist/Kardiologe/Angiologe
Kardiologische Gemeinschaftspraxis
Klinikum Pirna GmbH
Universitätsklinik Regensburg
Krankenhaus Reinbek St. Adolf-Stift
Kardiologische Gemeinschaftspraxis
Internistische Praxis
Zentrum für Prävention und Rehabilation
Marienkrankenhaus Soest
Praxisgemeinschaft Stuhr-Brinkum
Medizinische Universitätsklinik
Josephs-Hospital Warendorf
Kardiologische Praxis
Dr. Andreas Schreckenberg
ForschungsZentrum Ruhr
Helios Klinikum Wuppertal
Bajai Kórház
Budai Irgalmasrendi Kórház
Fővárosi Önkormányzat Károlyi Sándor Kórház és Rendelőintézet
Fovarosi Onkormanyzat Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet
Városi Önkormányzat Kórház-Rendelőintézet
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház
Jávorszky Ödön Kórház
Zala Megyei Kórház
Ospedali Riuniti di bergamo
Azienda Ospedaliera della Provincia di Lodi Presidio Ospedaliero di Codogno
Azienda Ospedaliera Universitaria San Martino-Dipartimento di Medicina Interna e Specialità Mediche
Azienda Ospeedaliera Carlo Poma
Azienda Ospedaliera Maggiore Della Carita' Di Novara
Istituto Clinico Humanitas
Hospital "Valentín Gómez Farías"
Cardioarritmias e Investigación, S.C.
Hospital Cardiológica Aguascalientes
Hospital de Jesus
Cardioprevent
Hospital Angeles de Puebla
Hospital General de Puebla
Instituto de Corazón de Querétaro, S.A. de C.V.
Hospital Central "Dr. Ignacio Morones Prieto"
Oddział Kardiologii z Zakładem Diagnostyki Kardiologicznej, Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital im. dr J. Biziela,
NZOZ "Medicus" Jacek Kubica
Wojewódzki Szpital Meijski im. Biziela, Oddział Kardiologii - SPZOZ
Oddział Chorób Wewnętrzych i Kardiologii , ZOZ w Debicy
Zakład Opieki Zdrowotnej Trójmiejskie Centrum Medyczne Sp. z o.o
Gabinet Kardiologiczny Medipuls
Gabinet Kardiologiczno-Internistyczny
Centrum Leczenia Chorób Cywilizacyjnych Oddz. Gdynia filla Fikakowo
NZOZ Medicus, Poradnia Kardiologiczna
Oddział Kardiologii i INK, SPZOZ nr 1
Mazowieckie Centrum Badań Klinicznych Iwona Czajkowska, Monika Śmietańska s.c.
Publiczny Specjalistyczny Zaklad Opieki Zdrowotnej Oddzial Kardiologiczny
Oddział Chorób Wewnętrznych i Farmakologii Klinicznej Samodzielny Publiczny Centralny Szpital Kliniczny im. Prof. Kornela Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach
Szpital Specjalistyczny w Kościerzynie, Oddział Kardiologii
Oddział Kardiologii, Szpital Specjalistyczny im. J. Dietla
"Klinika Choroby Wieńcowej Instytut Kardiologii, Collegium Medicum Uniwerytet Jagielloński
Oddzial Chorób Wewnętrznych III Szpital Specjalistyczny im.Stefana Zeromskiego, SPZOZ w Krakowie
Niepubliczny Zakład Opieki Zdrowotnej Specjalista Sp. z o.o.
Poradnia Kardiologiczna, Oddział Chorob Wewnetrznych Szpital Powiatowy w Limanowej
Oddział Internistyczno-Kardiologiczny Samodzielny Publiczny Zakład Opieki Zdrowotnej
"Oddzial Chorob Wewnetrznych i Kardiologii, Szpital Powiatowy im.Edmunda Biernackiego
Oddział Kardiologii, Nowa Sól
ZOZ w Oławie, Oddział Chorób Wewnętrznych
"Oddział Kardiologiczno-Internistyczny
"Oddział Kardiologiczny Publiczny Samodzielny ZOZ Wojewódzkie Centrum Medyczne
Specjalistyczny Zakład Opieki Zdrowotnej Poradnia lekarzy specjalistów "Jantar"
II Oddział Wewnętrzny Samodzielny Publiczny Zakład Opieki Zdrowotnej
"Samodzielny Szpital Wojewódzki im. Mikołaja Kopernika, Oddział Kardiologiczny
Medyczne Centrum Hetmańska, Indywiualna Specjalistyczna Praktyka Lekarska, Dr n. med. Piotr Leszczyński
Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwór
Oddział Wewnetrzny I, Szpital Kolejowy im. dr med. Włodzimierza Roeslera
Samodzileny Publiczny Zakład Opieki Zdrowotnej w Puławach, Szpital Specjalistyczny
Wojewódzki Szpital Zespolony, Oddział Kardiologiczny
Specjalistyczna Przychodnia Lekarska "Medikard"
Zakład Hemodynamiki, Wojewódzki Szpital Specjalistyczny
"Oddział Kardiologii z Pododdziałem Ostrych Zespołów Wieńcowych i z Ośrodkiem Implantacji Rozruszników Serca,
Oddział Kardiologii, SP ZZOZ Sandomierz
Oddział Kardiologiczny Wojewódzki Szpital Specjalistyczy w Siedlcach
Oddział Kardiologii Samodzielny Publiczny Zakład Opieki Zdrowotnej w Sieradzu im. Kardynała Stefana Wyszyńskiego
"Oddział Kardiologii, Wojewódzki Szpital Zespolony w Skierniewicach, "
NZOZ Przychodnia Zadebie, Przychodnia Kardiologiczna
"Oddział Kardiologii Inwazyjnej i Angiologii z Pr. Hemodynamiki
Szpital Specjalistyczny Św.Jana, Oddział Kardiologii,
Indywidualna Specjalistyczna Praktyka Lekarska
Poradnia Kardiologiczna
Specjalistyczny Gabinet Lekarski Internistyczno-Kardiologiczny-Cardiology
Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz", Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną
Oddział Kardiologii Wojewódzki Szpital Zespolony
Oddział Kardiologiczny Szpital Wolski im. dr Anny Gostyńskiej Samodzielny Publiczny Zakład Opieki Zdrowotnej
Samodzielny Publiczny Centralny Szpital Kliniczny Akademii Medycznej w Warszawie
II Klinika Choroby Wieńcowej Instytutu Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego
Centrum Leczenia Chorób Cywilizacyjnych
Międzyleski Szpital Specjalistyczny w Warszawie
NZOZ Starówka
"Oddział Kardiologiczny Wałbrzyski Ośrodek Kardiologii Interwencyjnej Specjalityczny Szpital im. Dr Alfreda Sokołowskiego
Osrodek Chorob Serca, Klinika Kardiologii 4 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Synexus SCM Sp.z o o.
Niepubliczny Zakład Opieki Zdrowotnej, Centrum Badań Klinicznych
"Śląskie Centrum Chorób Serca, III Katedra i Oddział Kliniczny Kardiologii Śląskiego Uniwersytetu Medycznego
Oddział Kardiologiczny Szpital Wojewódzki im. Kardynała Stefana Wyszyńskiego
Niepubliczny Zakład Opieki Zdrowotnej POLIMEDICA
All-Med Centrum Medyczne
Research and Cardiovascular Corp.
Spitalul Clinic Judetean de Urgenta Bacau
S.C. Duo Medical S.R.L.
Cardiomed SRL
Centrul Medical SANA
Institutul Inimii "Niculae Stanicioiu"
Cardiomed SRL
Dr. C.I. Parhon Hospital
Clinical county Hospital
Institutul de Boli Cardiovasculare si Transplan Tg. Mures
County Hospital
Novamed s.r.o.
Alian s.r.o.
5. Interna klinika LF UK, FNsP Bratislava, Nemocnica Ruzinov
Cardio D&R spol. s r.o.
Kardiomed s.r.o.
NZZ Kardiocentrum Nitra s.r.o.
MUDr. Tibor DURIS, CSc., s.r.o.
Nemocnica s poliklinikou Považská Bystrica
Fakultna Nemocnica Trencin
Žilpo s.r.o.
Medivasa s.r.o.
"Klinichne obyednannia shvydkoi medychnoi dopomogy, m. Dnipropetrovs'k,Dnipropetrovs'ka derzhavna medychna akademiya, kafedra gospital'noi terapii #2
Oblasnyi klinichnyi kardiologichnyi dyspanser, m. Ivano-Frankivsk, Ivano-Frankivskyi derzhavnyi medychnyi universytet, kafedra terapii # 3
TOV "Kardiologichna klinika "Sertse i sudyny" m. Kyiv
Natsionalnyi naukovyi tsentr "Instytut kardiologii im. akad. M.D. Strazheska" AMN Ukrainy, m. Kyiv, viddilenia symptomatychnykh arterial'nykh gipertenziy
Natsionalnyi naukovyi tsentr "Instytut kardiologii im. akad. M.D. Strazheska", viddil reanimatsii ta intensyvnoi terapii, m. Kyiv
Komunal'na ustanova "Oblasnyi kardiologichnyi dyspanser", viddilenia intensyvnoi terapii, m. Zaporizhzhia
Kardioarytmologichnyi tsentr Zhytomyrs'koi oblasnoi klinichnoi likarni im. O.F. Gorbachevs'kogo, m. Zhytomyr

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Composite of upper gastrointestinal clinical events, including gastroduodenal bleeding, symptomatic gastroduodenal ulcer, persistent pain with multiple gastric erosions, obstruction or perforation

Secondary Outcome Measures

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

Occurrence of a cardiovascular event (cardiovascular death, nonfatal myocardial infarction, CABG or PCI, or confirmed ischemic stroke

Full Information

NCT ID

NCT00557921

First Posted

November 12, 2007

Last Updated

January 27, 2009

Sponsor

Cogentus Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00557921

Brief Title

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

Acronym

COGENT-1

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Terminated

Why Stopped

Terminated by Sponsor

Study Start Date

December 2007 (undefined)

Primary Completion Date

November 2009 (Anticipated)

Study Completion Date

November 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Cogentus Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome, Myocardial Infarction, Coronary Artery Disease, Percutaneous Coronary Intervention

Keywords

ACS, CAD, MI, PCI, PTCA, NSTEMI, STEMI, acute coronary syndrome, cerebrovascular disorders, coronary artery stent placement, coronary thrombosis, myocardial infarction, myocardial ischemia, percutaneous coronary intervention, percutaneous transluminal coronary angioplasty, peripheral vascular diseases, duodenal obstruction, duodenal ulcer, dyspepsia, esophagitis, peptic, gastric outlet obstruction, gastroduodenal ulcer, gastroesophageal reflux disease, gastrointestinal hemorrhage, peptic ulcer, peptic ulcer perforation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin

Intervention Description

(CGT-2168 active and Comparator placebo, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)

Intervention Type

Drug

Intervention Name(s)

Plavix (clopidogrel 75 mg) and aspirin

Intervention Description

(CGT-2168 placebo and Comparator active, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)

Primary Outcome Measure Information:

Title

Composite of upper gastrointestinal clinical events, including gastroduodenal bleeding, symptomatic gastroduodenal ulcer, persistent pain with multiple gastric erosions, obstruction or perforation

Time Frame