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

This study has been terminated.
(Terminated by Sponsor)
Sponsor:
Information provided by:
Cogentus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00557921
First received: November 12, 2007
Last updated: January 27, 2009
Last verified: January 2009
  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:


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):
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:
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

Additional relevant MeSH terms:
Aspirin
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Ticlopidine
Clopidogrel
Omeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 23, 2014