Russian observational program ODA

Conditions

Chronic coronary artery disease and stable angina Circulatory System Chronic coronary artery disease and stable angina

М. Г. Глезер, В. А. Выгодин, ODA investigators

Cardiology and Therapy2020-05-198 citations

Effectiveness of Long-acting Trimetazidine in Different Clinical Situations in Patients with Stable Angina Pectoris: Findings from ODA Trial.

Glezer MG, Vygodin VA, ODA investigators.

2019-02-183 citations

10.1007/s40119-019-0128-3

Anti-Anginal Effectiveness and Tolerability of Trimetazidine Modified Release 80 Mg Once Daily in Stable Angina Patients in Real-World Practice.

Glezer MG, Vygodin VA, ODA investigators.

2018-08-1310 citations

10.1007/s12325-018-0756-3

Interventions

This a non-interventional study. Participants are included in this study is they have a confirmed diagnosis of chronic coronary artery disease and stable angina and have been determined by a physician

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of Chronic Coronary Artery Disease and stable angina. Special care has to be taken that inclusion of patients into the non-interventional study is exclusively determined by the decision of the physician regarding medical meaningfulness and necessity of treatment with Preductal® OD 80 mg. 2. Signed informed consent 3. Aged 18 to 75 years old

Exclusion criteria

Exclusion criteria: 1. Age over 75 years or under 18 years 2. Hypersensitivity to the active substance or to any of the excipients listed in Preductal® OD 80 mg SmPC 3. Parkinson disease, parkinsonian symptoms, tremors, restlessleg syndrome, and other related movement disorders 4. Severe renal impairment (creatinine clearance < 30ml/min) 5. Moderate renal impairment (creatinine clearance [30-60] ml/min) 6. Stable angina pectoris FC IV 7. Myocardial Infarction (MI) in the last 3 months before inclusion 8. Stroke/TIA in the last 3 months before inclusion 9. Uncontrolled HT (BP over 180/100 mm Hq) inspite of hypotensive therapy 10.Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
1. Number of angina attacks is measured using the patient interviews at baseline, one and three months 2. Use of short-acting nitrates is measured using the patient interviews at baseline, one and three months 3. Symptomatic classification measured is measured using Canadian Cardiovascular Society Classification of Symptoms of Angina at baseline, one and three months 4. Daily activity is measured by patients using visual scale at baseline, one and three months	—

Measure

Time frame

1. Number of angina attacks is measured using the patient interviews at baseline, one and three months 2. Use of short-acting nitrates is measured using the patient interviews at baseline, one and three months 3. Symptomatic classification measured is measured using Canadian Cardiovascular Society Classification of Symptoms of Angina at baseline, one and three months 4. Daily activity is measured by patients using visual scale at baseline, one and three months

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Secondary

Measure	Time frame
1. Patients’ compliance/adherence is measured using questionnaire at baseline, one and three months 2. General tolerance and adverse events (AE) / adverse drug reactions (ADR) under Preductal® OD 80 mg therapy is measured using Adverse event / Adverse drug reaction / Special situation form collection at one and three months 3. Clinical assessment in symptomatic patients with angina pectoris is measured using questionnaire at month three	—

Measure

Time frame

1. Patients’ compliance/adherence is measured using questionnaire at baseline, one and three months 2. General tolerance and adverse events (AE) / adverse drug reactions (ADR) under Preductal® OD 80 mg therapy is measured using Adverse event / Adverse drug reaction / Special situation form collection at one and three months 3. Clinical assessment in symptomatic patients with angina pectoris is measured using questionnaire at month three

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Countries

Russian Federation

Outcome results

None listed