Stable Angina Pectoris MedDRA version: 15.0 Level: LLT Classification code 10049194 Term: Stable angina pectoris System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Ranexa® 500 mg
Product Name: Ranexa
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: RANOLAZINE
CAS Number: 95635-55-5
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Menarini International Operations Luxembourg S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. 1. Male and female patients (females of childbearing potential must have a negative urine pregnancy test and must be using adequate contraceptive precautions, see also section 17.4) 2. Performed coronary angiography with or without initial PCI more than 24 hours before MRI 3. Remaining = 70% stenosis of a coronary artery bigger than 2 mm diameter (not corrected by PCI) 4. Indication of further interventional treatment 5. Wall motion abnormalities in at least one segment; if segment 17 is affected, an additional segment has to show wall motion abnormalities (for the segment-model, see section 13.3.3) 6. History of chronic angina pectoris 7. Age = 18 years 8. Normalized blood pressure =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not enrolled in this study: 1. Cardiac instability, e.g. acute coronary syndrome as indication for the coronary angiography (ST-elevation or positive troponin testing) 2. Contraindication for MRI (e.g. implanted pace maker, internal defibrillator, MRI incompatible devices or metals) 3. Contraindication for dobutamine, atropine, gadolinium based contrast agent, or metoprolol 4. Patients with heart failure classification NYHA III and NYHA IV 5. Myocardial infarction during the last 3 days prior to treatment with ranolazine 6. Severe renal impairment (GFR 2.5× upper normal limit) 8. Allergic asthma bronchiale 9. Hyperthyroidism or Hashimoto thyreoiditis 10. Myocarditis or inflammatory heart disease 11. Hypertrophic obstructive cardiomyopathy 12. Concomitant administration of class Ia (e.g. quinidine) or class III (e.g. dofetilide, sotalol) antiarrhythmics, except for amiodarone 13. Long acting nitrates 14. Concomitant treatment with potent inhibitors of CYP3A (see also section 11.4) 15. Concomitant treatment with CYP3A inducers (see also section 11.4) 16. Dronedarone 17. Use of greater than 1000 mg daily dose of metformin during the study 18. Hypersensitivity to the active substance or to any of the excipients 19. Hypersensitivity to dobutamine, atropine, gadolinium based contrast agent, or metoprolol 20. Concomitant administration of > 20 mg simvastatin/day 21. History of ECG abnormalities that, in the opinion of the investigator, render the patient unsuitable for the trial, e.g. history of long QT syndrome or significant prolonged QT interval (> 120%) 22. Participation in another trial of an investigational drug or device within 30 days prior to screening 23. Pregnant and breast-feeding women (females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test) 24. Less than 3 months since delivery, abortion, or lactation before the first screening/examination visit 25. Severe psychiatric disorders/neurological disorders 26. Suspected abuse of alcohol, analgesics or psychotropic drugs 27. Disabling or terminal illness 28. Inability or unwillingness to issue the informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of this study is to evaluate the efficacy of ranolazine treatment in terms of changes of wall motion abnormalities in ischemic areas in patients treated with ranolazine compared to patients treated with placebo at follow-up magnetic resonance examination after five weeks of ranolazine treatment.;Secondary Objective: Secondary Objectives: Evaluation of the heart’s perfusion deficit, dynamic geometry and related variables: • transmural extent of perfusion deficit • hyperenhancement • new hyperenhancement • left ventricular ejection fraction (LVEF, %) • left ventricular end-diastolic volume index (LVEDVI, mL/m2) • left ventricular end-systolic volume index (LVESVI, mL/m2) • stroke volume index (SVI, mL/m2) • left ventricular mass index (LVMI, g/m2) • left ventricular mass absolute (LV mass, g) ;Primary end point(s): Primary end point: The changes of the wall motion abnormalities will be compared between the two treatment groups (ranolazine versus placebo);Timepoint(s) of evaluation of this end point: After 5 week, day 35 +/- 3 of study drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: to compare the effects of ranolazine versus placebo on the evaluation of the heart’s perfusion deficit, dynamic geometry and related variables: • transmural extent of perfusion deficit • hyperenhancement • new hyperenhancement • left ventricular ejection fraction (LVEF) • left ventricular end-diastolic volume index (LVEDVI) • left ventricular end-systolic volume index (LVESVI) • stroke volume index (SVI) • left ventricular mass index • left ventricular mass absolute. ;Timepoint(s) of evaluation of this end point: After 5 week, day 35 +/- 3 of study drug administration | — |
Countries
Germany
Contacts
Public ContactProject Manager
Dr. Notghi Contract Research GmbH
Outcome results
None listed