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

Purpose

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.

Condition	Intervention	Phase
Acute Coronary Syndrome Myocardial Infarction Coronary Artery Disease Percutaneous Coronary Intervention	Drug: CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin Drug: Plavix (clopidogrel 75 mg) and aspirin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Bleeding GERD Gastrointestinal Bleeding Heart Attack Indigestion Peptic Ulcer

Drug Information available for: Aspirin Clopidogrel bisulfate

U.S. FDA Resources

Further study details as provided by Cogentus Pharmaceuticals:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Composite of gastroduodenal bleeding, symptomatic gastroduodenal ulcer, obstruction or perforation [ Time Frame: Anticipated minimum of 48 weeks, up to end of study ] [ Designated as safety issue: No ]
Composite of gastroduodenal bleeding, obstruction or perforation [ Time Frame: Anticipated minimum of 48 weeks, up to end of study ] [ Designated as safety issue: No ]
Discontinuation of study medication attributed to gastrointestinal signs or symptoms [ Time Frame: Anticipated minimum of 48 weeks, up to end of study ] [ Designated as safety issue: No ]
Gastroesophageal reflux disease, as evidenced by symptomatic endoscopically-confirmed erosive esophagitis [ Time Frame: Anticipated minimum of 48 weeks, up to end of study ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	5000
Study Start Date:	December 2007
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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)
Active Comparator: 2	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)

Eligibility


Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557921

Show 491 Study Locations

Sponsors and Collaborators

Cogentus Pharmaceuticals

Investigators


Study Director:	Pablo Lapuerta, MD	Cogentus Pharmaceuticals

More Information

No publications provided by Cogentus Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Pablo Lapuerta, MD, Cogentus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00557921 History of Changes
Other Study ID Numbers:	CG104, EudraCT 2007-005891-15
Study First Received:	November 12, 2007
Last Updated:	January 27, 2009
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Bulgaria: Bulgarian Drug Agency Chile: Instituto de Salud Pública de Chile Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Slovakia: State Institute for Drug Control Ukraine: State Pharmacological Center - Ministry of Health Italy: Ethics Committee Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Cogentus Pharmaceuticals:


acute coronary syndrome gastric outlet obstruction ACS CAD MI PCI PTCA NSTEMI STEMI 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 gastroduodenal ulcer gastroesophageal reflux disease gastrointestinal hemorrhage peptic ulcer peptic ulcer perforation

Additional relevant MeSH terms:


Acute Coronary Syndrome Syndrome Chest Pain Coronary Artery Disease Coronary Disease Infarction Myocardial Infarction Myocardial Ischemia Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Disease Heart Diseases Ischemia	Necrosis Pain Pathologic Processes Signs and Symptoms Vascular Diseases Aspirin Clopidogrel Ticlopidine Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antipyretics Antirheumatic Agents Cardiovascular Agents

ClinicalTrials.gov processed this record on February 25, 2015