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

Sponsored by:	Cogentus Pharmaceuticals
Information provided by:	Cogentus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00557921

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 III

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

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

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
1: Experimental	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)
2: Active Comparator	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

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

Contacts

Contact: Pablo Lapuerta, MD

650-543-4730

clinicaltrials@cogentus.net

Show 493 Study Locations

Sponsors and Collaborators

Cogentus Pharmaceuticals

Investigators

Study Director:

Pablo Lapuerta, MD

Cogentus Pharmaceuticals

More Information

Responsible Party:	Cogentus Pharmaceuticals ( Pablo Lapuerta, MD )
Study ID Numbers:	CG104, EudraCT 2007-005891-15
Study First Received:	November 12, 2007
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00557921
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 Publica de Chile; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; 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:

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

Study placed in the following topic categories:

Myocardial Ischemia
Omeprazole
Peptic Ulcer Perforation
Arteriosclerosis
Hemorrhage
Cerebrovascular Disorders
Gastroesophageal Reflux
Gastric Outlet Obstruction
Esophagitis
Necrosis
Esophagitis, Peptic
Aspirin
Myocardial Infarction
Peptic Ulcer
Arterial Occlusive Diseases

Ticlopidine
Peripheral Vascular Diseases
Heart Diseases
Ulcer
Vascular Diseases
Gastrointestinal Hemorrhage
Coronary Thrombosis
Ischemia
Dyspepsia
Thrombosis
Duodenal Ulcer
Coronary Disease
Clopidogrel
Duodenal Obstruction
Acute Coronary Syndrome

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Disease
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents
Pathologic Processes

Analgesics, Non-Narcotic
Sensory System Agents
Syndrome
Therapeutic Uses
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009