EUCTR2007-005891-15-SK进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria:
- •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
排除标准
- •Exclusion Criteria:
- •Any of the criteria will result in exclusion
- •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.
研究者
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