CTRI/2024/07/069720尚未招募Unknown
A Prospective, Multicenter, Open-label, Post-Marketing Observational Study to Evaluate the Anti-Anginal Effectiveness of Trimetazidine 60 mg Once Daily Formulation in Stable Angina Patients in Real-World Practice
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- 1. Change in the mean number of weekly angina attacks from baseline to 3 months.
研究概览
简要总结
Post-Marketing Observational Study to Evaluate the Anti-Anginal Effectiveness of Trimetazidine 60 mg Once Daily in Stable Angina Patients. approximately on 160 patients from approximately 10 clinical sites.There are three visits in the study and study duration is of 90 days +/- 3 days window period.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •The subjects will be included in the study based on the following criteria:
- •Male/female of ≥ 18 years of age.
- •Patient diagnosed with CSA by HCP (health care professional) and Prescribed Trimetazidine 60 mg OD as per HCP’s discretion.
- •Patient willing to give written informed consent to participate into the study.
- •Willing to take the study drug as prescribed by the investigator.
- •Willing to comply with the protocol requirements.
排除标准
- •A patient will be excluded from the study if they meet any of the following criteria:
- •Known hypersensitivity to Trimetazidine or excipients of the formulation.
- •Parkinson’s disease, parkinsonian symptoms, tremors, restless leg syndrome and other related movement disorders.
- •Known case of severe renal impairment.
- •Any other condition/ uncontrolled co-morbid conditions that, in the opinion of the investigator, does not justify the inclusion of the patient in the study.
- •Pregnant and lactating females.
结局指标
主要结局
1. Change in the mean number of weekly angina attacks from baseline to 3 months.
时间窗: 3 months
2. Change in number of short acting nitrates consumed per week from baseline to 3 months.
时间窗: 3 months
次要结局
- 1. Number of ADR/OPRI during the study period.(2. Measure patient characteristics like age, gender, comorbidities, medical and personal history and past treatment history of patients.)
研究者
Dr Arindam Pande
Medica super speciality hospital
研究点 (1)
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