Stable angina Circulatory System Angina
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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