Combining Trimetazidine with a Hemodynamic Agent for Symptomatic Stable Angina
Effectiveness and Impact on Quality of Life of a Combination of Trimetazidine With One Hemodynamic Agent (ß-blocker or Ca-channel Blocker), in Patients Recently Diagnosed With Stable Angina and Still Symptomatic Despite First Line Hemodynamic Therapy: a Prospective, International, Non-interventional Study.
This study is testing if adding trimetazidine to the treatment plan can help people with stable angina who still have symptoms feel better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Servier Industry-sponsored |
| Locations | 1 site (Braşov) |
| Trial ID | NCT06298045 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of adding trimetazidine to the treatment regimen of patients recently diagnosed with stable angina who continue to experience symptoms despite being on first-line hemodynamic therapy. The primary focus is on measuring the reduction of angina symptoms and improvements in quality of life using the Seattle Angina Questionnaire-7 items. Additionally, participants will complete a BEAMER questionnaire to contribute to a related research initiative. The study is observational and aims to gather real-world data on treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been recently diagnosed with symptomatic stable angina and are currently on first-line hemodynamic therapy but remain symptomatic.
Not a fit: Patients who have contraindications to trimetazidine or those who have previously been treated with it will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of stable angina and enhance patients' quality of life.
How similar studies have performed: While this approach is not widely tested, it builds on existing treatments for angina, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female recently diagnosed symptomatic stable Angina patients * Age ≥18 years old * Patient already treated by one first line antianginal haemodynamic agent (ß-blocker or Ca-channel blocker) (according to CCS management guidelines 2019) and still symptomatic after initiation of this antianginal treatment. * Patient for whom the physician intends to prescribe trimetazidine based on her/his daily medical practice in the management of symptomatic Angina pectoris, respecting the SmPC in force in the country. Such treatment decision must be taken independently from the participation of the patient in the study. * Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria: * Any contra-indication to trimetazidine according to SmPC * Patient already treated with trimetazidine before entry into the study. * Pregnancy or intention to become pregnant or lactating women during the study.
Where this trial is running
Braşov
- Thera Card Srl — Braşov, Romania (Recruiting)
Study contacts
- Study coordinator: Valerie Lehner
- Email: valerie.lehner@servier.com
- Phone: +33155726000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.