Stable angina with normal ejection fraction MedDRA version: 20.0 Level: PT Classification code 10002383 Term: Angina pectoris System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: RANEXA - 375 MG-COMPRESSA A RILASCIO PROLUNGATO-USO ORALE-BLISTER(PVC/PVDC/ALLUMINIO) 30 COMPRESSE
Product Name: RANEXA
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN:
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female gender (females of childbearing potential must be using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner); • Females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test; • Patients which diagnosis of stable effort chronic angina based on clinical symptoms (angina; ischemic equivalents) or ischemia tests (stress ECG/stress-exercise echocardiography/Miocardial perfusion scintigraphy) independently from baseline antianginal therapy. • Patients aged = 18 years; • Patients with normal LV ejection fraction (EF) without LV wall motion abnormalities detected by standard echocardiography or if abnormalities are present, the post systolic thickening must be present in a different, non-contiguous segment; • Patients with post systolic thickening independently from baseline antianginal therapy, defined as the presence of SI = 50%, 5 min. during and/or after the supine bicycle speckle tracking echo stress (speckle tracking) test performed by using the standard Bruce protocol; • Presence of sinus rhythm; • Written informed consent prior to enrolment into the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: • Females of childbearing potential not using adequate contraceptive precautions; • Presence of unstable angina, left main trunk disease, previous myocardial infarction, previous cardiac surgery, artificial pacemaker, non-sinus rhythm, significant valvular heart disease; • Presence of congestive heart failure; • Presence of Chronic Obstructive Airways Disease; • Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone). Grapefruit juice is also a potent CYP3A4 inhibitor. • Concomitant administration of Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone. • Any clinically relevant haematological or biochemical abnormality on routine screening, according to Investigator’s judgment; • Severe concurrent pathology, including terminal illness (cancer, AIDS, etc.); • Severe renal impairment defined as GFR 2.5 mg/dL; BUN >60 mg/dL; • Moderate or severe hepatic impairment or hepatic insufficiency defined as SGOT or SGPT > 2 times greater than normal upper limit or total serum bilirubin > 1.5 times greater than normal upper limit; • Dementia, psychosis, alcoholism (>350 g ethanol/week) or chronic abuse of medicines, drugs or psychoactive substances; • Females who are pregnant or lactating; • Conditions which in the Investigator’s opinion may interfere with the study’s execution or due to which the patient should not participate for safety reasons; • Risk of low patient cooperation; • Inability or unwillingness to issue the informed consent; • Inability to perform an exercise stress test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the efficacy of ranolazine in reducing segmentary post systolic thickening due to myocardial ischemia - allowing the synchronisation of the impaired myocardial segments - using strain imaging (SI) derived from 2-dimensional speckle-tracking echocardiography in patients with stable effort angina. ;Secondary Objective: Demonstrate the efficacy of ranolazine on exercise capacity in patients affected by stable effort angina using the supine bicycle exercise test and the symptomatic status. The assessment of safety by evaluation of adverse events, laboratory findings, the rest standard 12-lead ECG, and physical examination will also be considered as secondary study objectives.;Primary end point(s): Evaluation of SI in patients with stable effort angina after 2 months and 3 weeks of treatment with ranolazine + standard therapy (ST) or standard therapy (ST) alone using the 2-dimensional speckle-tracking echocardiography. ;Timepoint(s) of evaluation of this end point: 2 MONTHS AND 3 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The change in Exercise capacity after 2 months and 3 weeks of treatment with ranolazine 375/500/750 mg /bid + ST or ST alone in the two study groups; The change in Symptomatic Status Evaluation using the Seattle Angina Questionnaire, after 2 months and 3 weeks of treatment with ranolazine 375/500/750 mg /bid + ST or ST alone in the two study groups; The change in Symptomatic Status Evaluation using the Seattle Angina Questionnaire, after 1 month of treatment with ranolazine 375/500/750 mg /bid + ST or ranolazine 500 mg/bid + ST in the two study groups from visit 7 to visit 8 (end study visit).; The change in SI, after 1 month of treatment with ranolazine 375/500/750 mg /bid + ST or ranolazine 500 mg/bid + ST in the two study groups from visit 7 to visit 8 (end study visit).; The change in Exercise capacity, after 1 month of treatment with ranolazine 375/500/750 mg /bid + ST or ranolazine 500 mg/bid + ST in the two study groups from visit 7 to visit 8 (end study visit).;Timepoint(s) of evaluation of this end point: 2 MONTHS and 3 WEEKS; 2 MONTHS AND 3 WEEKS; 1 MONTH; 1 MONTH; 1 MONTH | — |
Countries
Italy
Contacts
Public ContactU.O. CARDIO - ANGIOLOGIA
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Outcome results
None listed