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Evaluation of Anti-Anginal Effectiveness of Trimetazidine 60 mg Once Daily in Stable Angina Patients

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 - NA

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/07/069720
Enrollment
160
Registered
2024-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I209- Angina pectoris, unspecified

Interventions

Intervention1: Trimetazidine 60 mg,: Once Daily, Capsule, Route of administration-Oral, Duration-03 Months Control Intervention1: NA: NA

Sponsors

Abbott Healthcare Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1. Change in the mean number of weekly angina attacks from baseline to 3 months. 2. Change in number of short acting nitrates consumed per week from baseline to 3 months.Timepoint: 3 months

Secondary

MeasureTime frame
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. 3. Analyze the co-prescription data with Trimetazidine.Timepoint: 3 months.

Countries

India

Contacts

Public ContactDr Shivani Acharya

Abbott Healthcare Private Limited

ashwini.pawar@abbott.com7710004176

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026