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Antianginal efficacy of trimetazidine in daily practice

Evidence for the antianginal efficacy of trimetazidine in patients with stable angina in daily practice

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN65209863
Enrollment
896
Registered
2018-04-27
Start date
2015-03-01
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Stable angina Circulatory System Angina

Interventions

Trimetazidine 35 mg bid was added to antianginal therapy by investigators according to the medical merit and necessity of therapy.

Sponsors

Servier
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged >18 years 2. Provided informed consent 3. =3-month history of stable angina documented by ECG-confirmed myocardial ischaemia and/or prior myocardial infarction, revascularisation or >50% coronary stenosis, and treated for CAD in the past month. 4. Inclusion was decided solely by physicians according to the medical merit and necessity of treatment with TMZ 35 mg bid

Exclusion criteria

Exclusion criteria: 1. Canadian Cardiovascular Society (CCS) class 4 stable angina 2. Hospitalisation in the past 3 months for acute coronary syndrome (infarction or unstable angina) 3. Uncontrolled hypertension (systolic >180 mmHg or diastolic >100 mmHg) despite ongoing antihypertensive treatment 4. New York Heart Association (NYHA) class III or IV heart failure 5. Pregnancy or breastfeeding 6. CAD surgery scheduled in the next 6 months 7. Severe hepatic or renal failure, or other severe chronic disease requiring continuous treatment 8. Known poor treatment compliance 9. Intolerance or contraindications to TMZ.

Design outcomes

Primary

MeasureTime frame
Angina frequency and short-acting nitrate use over the 6 months, assessed using patient's diary at baseline, week 2, and months 2, 4, and 6

Secondary

MeasureTime frame
1. Walking distance eliciting angina assessed using patient's diary at baseline, week 2, and months 2, 4, and 6. The distance was recorded by patients in diary as the distance they walked (in m) before experiencing angina symptoms, in conditions of daily activity, when they walked at their own pace and on mostly flat surfaces. 2. Patient self-reported well-being on a visual analog scale from 0 (very good) to 100 (very bad) at baseline, week 2, and months 2, 4, and 6.

Countries

Russian Federation

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026