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 - COGENT-1, Clopidogrel and the Optimization of Gastrointestinal Events

• Conditions: Gastrointestinal events including bleeding in patients receiving dual anti-platelet therapy (clopidogrel and aspirin); MedDRA version: 9.1Level: HLGTClassification code 10018012Term: Gastrointestinal signs and symptoms

• Registration Number: EUCTR2007-005891-15-DE
• Lead Sponsor: Cogentus Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-10
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Inclusion Criteria:

To be included in the clinical trial, patients must meet all 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.
•Age = 21 years. No more than 40% of participants will be less than 65 years of age at randomization.
•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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria:

Patients will be excluded from the clinical trial if they meet any of the Exclusion
Criteria:
• Patients who are 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 with vitamin K antagonists (coumarins) that
cannot be safely discontinued for duration of study.
• Recent fibrinolytic therapy (for fibrin-specific and nonfibrin-specific
agents, administration < 24 hours and < 48 hours before
randomization, respectively).
• 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 the time of randomization, refractory
ventricular arrhythmias, or congestive heart failure (New York
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.
• Platelet count < 100,000/mL at screening.
• Anemia (hemoglobin < 10 g/dL) at screening.
• Systemic corticosteroids except low-dose oral corticosteroids
equivalent to prednisone = 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 (not
approved) 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.
• Clinically significant laboratory abnormality at screening or any
other condition that, in the opinion of the Investigator, precludes
participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified