Evaluation of Anti-Anginal Effectiveness of Trimetazidine 60 mg Once Daily in Stable Angina Patients
- Conditions
- Health Condition 1: I209- Angina pectoris, unspecified
- Registration Number
- CTRI/2024/07/069720
- Lead Sponsor
- Abbott Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
The subjects will be included in the study based on the following criteria:
1. Male/female of = 18 years of age.
2. Patient diagnosed with CSA by HCP (health care professional) and Prescribed Trimetazidine 60 mg OD as per HCP’s discretion.
3. Patient willing to give written informed consent to participate into the study.
4. Willing to take the study drug as prescribed by the investigator.
5. Willing to comply with the protocol requirements.
A patient will be excluded from the study if they meet any of the following criteria:
1. Known hypersensitivity to Trimetazidine or excipients of the formulation.
2. Parkinson’s disease, parkinsonian symptoms, tremors, restless leg syndrome and other related movement disorders.
3. Known case of severe renal impairment.
4. 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.
5. Pregnant and lactating females.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in the mean number of weekly angina attacks from baseline to 3 months. <br/ ><br>2. Change in number of short acting nitrates consumed per week from baseline to 3 months.Timepoint: 3 months
- Secondary Outcome Measures
Name Time Method 1. Number of ADR/OPRI during the study period. <br/ ><br>2. Measure patient characteristics like age, gender, comorbidities, medical and personal history and past treatment history of patients. <br/ ><br>3. Analyze the co-prescription data with Trimetazidine.Timepoint: 3 months.