ISRCTN29992579
Completed
Phase 4
Evaluation of the efficacy, tolerability, and also the influence on quality of life of the drug Preductal OD, 80 mg sustained-release capsules (JSC Servier, Russia) in patients with coronary artery disease (CAD) and angina pectoris during a 3-month treatment in combination with bisoprolol in an outpatient setting
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Servier (Russia)
- Enrollment
- 1939
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34958427/ (added 30/12/2021)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Confirmed diagnosis of CAD, class II or III stable angina
- •2\. Treatment with bisoprolol
- •3\. Signed informed consent of a patient
- •4\. No contraindications to the prescription of PREDUCTAL as indicated in the instruction for use of medicinal product for medical purposes
Exclusion Criteria
- •1\. Age below 18 years
- •2\. Class IV stable angina
- •3\. Unstable angina
- •4\. Myocardial infarction within 3 months prior to the inclusion in the program
- •5\. Cerebrovascular accident (stroke of various cause; TIA) within 3 months prior to the inclusion in the program
- •6\. Uncontrolled arterial hypertension (BP above 180 and 100 mm Hg), despite the current antihypertensive treatment.
- •7\. Pregnancy, breastfeeding.
- •8\. Inability to understand the nature of the program and follow the recommendations.
- •9\. Presence of contraindications or known intolerance to trimetazidine.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
ens replacement planning in patients with cataracts and corneal astigmatism using the iTrace programCataracts with corneal astigmatismEye DiseasesISRCTN94956424Shanxi Eye Hospital63
Completed
Not Applicable
A research study in Bosnia and Herzegovina to test an intervention called Volunteer Support, designed to improve care for people living in the community with severe mental illnessPatients with severe mental illness (including psychosis)Mental and Behavioural DisordersISRCTN51290984Queen Mary University of London101
Completed
Not Applicable
A research study in Pakistan to test a family involvement intervention, designed to improve care for people living in the community with common mental health conditionsCommon mental health conditions (including mild to moderate depression and anxiety)Mental and Behavioural DisordersISRCTN12299326Queen Mary University of London73
Completed
Not Applicable
A research study in Colombia to test an intervention called Volunteer Support, designed to improve care for people living in the community with severe mental illnessISRCTN72241383Queen Mary University of London55
Completed
Not Applicable
Assessment of the effectiveness and acceptability of an online intervention for adapting well in the face of adversity, trauma, tragedy, threats or significant sources of stressResilience, which is defined in this study as a dynamic mental health adaptation, which individuals are able to face and recover from significant distress or trauma.Mental and Behavioural DisordersISRCTN11866034SilverCloud Health82