CTRI/2021/11/037831进行中（未招募）3 期
A multicenter, randomized, double-blind, double dummy, Phase III study to compare safety and efficacy of fixed dose combination of Aspirin 150 mg and Pantoprazole 20 mg versus Aspirin 150mg alone for the prevention of gastroduodenal mucosal damage in patients taking aspirin for secondary prevention of cardiovascular disease or cerebrovascular disease
Alkem Laboratories Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Willing to provide voluntary written informed consent.
- •2. Willing and able to comply with protocol requirements.
- •3. Male or female patients with age ââ?°Â¥ 55 years at the time of screening.
- •4. Patients taking Aspirin ââ?°Â¤ 150 mg daily for ââ?°Â¥3 to ââ?°Â¤6 months and expected to require daily aspirin therapy for at least 6 months
- •5.Patients requiring continuous low-dose aspirin for the secondary prevention of cardiovascular disease or cerebrovascular disease
- •a. Patients diagnosed with coronary heart disease, peripheral vascular disease or ischemic stroke or transient ischemic attacks.
- •b. Or patients with history of:
- •i. Coronary artery bypass graft (CABG);
- •ii. Percutaneous coronary intervention (PCI) with or without stent; or
- •iii. Carotid endarterectomy.
- •6. Patients with 0 to 10 gastric or duodenum erosion(s) or submucosal hemorrhage(s) (Lanza Score 0 to 2).
- •Gastro duodenal injury will be determined by endoscopic examination. Gastric and duodenal lesions will be scored using the Lanza (1988) method.
排除标准
- •1. Known hypersensitivity or intolerance to Aspirin, Pantoprazole or related class of drugs or any of the excipients of investigational product.
- •2. Concurrent erosive or ulcerative esophagitis, esophageal stricture, severe esophagitis, long-segment Barrettââ?¬•s esophagus, history of serious upper Gastro-intestinal events, such as perforation, or obstruction, pyloric stenosis, previous gastric or duodenal surgery.
- •3. Use of corticosteroids (except the use of inhaled steroids for asthma), bisphosphonates, acid suppressants, prostaglandin analogues or anticoagulant or any other prohibited medications within last 4 weeks prior to screening or their planned co-prescription during the study participation.
- •4. Positive test result for H. pylori at Screening.
- •5. Had a revascularization procedure (i.e., CABG, Percutaneous Transluminal Coronary Angioplasty, or carotid endarterectomy) less than 3 months prior to Screening.
- •6. Unstable hypertension as judged by Investigator.
- •7. Uncontrolled diabetes mellitus defined as HbA1c value > 10%.
- •8. Unstable cardio- or cerebrovascular disease that would endanger the subject if they participated in the trial.
- •9. Clinically significant valvular disease requiring treatment with anticoagulant.
- •10. Congestive heart failure (CHF) or other Class III or IV cardiovascular symptoms according to New York Heart Association (NYHA) Functional Classification.
- •11. Blood coagulation disorder.
- •12. Any illness with co-prescription of NSAID; Patients who have taken NSAID in last 4 weeks prior to screening.
- •13. Any psychiatric illness.
- •14. History of seizure.
- •15. History of alcoholism or drug addiction within a year prior to enrollment in the study.
- •16. Severe hepatic dysfunction (i.e., cirrhosis or portal hypertension).
- •17. Laboratory findings measured at screening:
- •a. Hemoglobin <10 g/dl
- •b. Neutrophils < 2000/mm3
- •c. Platelets <100,000/mm3
- •d. Total bilirubin > 1.5 X ULN
- •e. ALT/ AST > 2.5 X ULN
- •f. Serum creatinine >1.25 X ULN
- •g. Other than noted specifically, any screening laboratory value that is clinically significant in the Investigatorââ?¬•s opinion and would endanger a subject, if the subject participates in the study
- •18. Patients with positive serology for HIV, HBV and HCV.
- •19. History of malignancy, treated or untreated, within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin.
- •20. Previous participation in any clinical trial within 1 month before the entry of the study.
- •21. Any condition that, in the opinion of the Investigator, may have either put the subject at risk or influenced the results of the study.
- •22. Pregnant or lactating women.
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