EUCTR 2011‐001278‐24.

Trial name or title	2011‐001278‐24 / MEIN/10/Ran‐Cad/003
Methods	Study design: parallel‐group trial Duration of follow‐up: 24 weeks Method of randomisation: not described Method of concealment of allocation: not described Blinding: double‐blind Power calculation: not mentioned Phases of the study: 1 (treatment phase)
Participants	Total number: 1460 (estimated) Country of enrolment: Greece, Switzerland Setting/location: not specified Diagnostic criteria (stable angina pectoris): exercise angina in patients with CAD (macrovascular angina) Comorbidities: none Inclusion criteria: Male and female patients (females of childbearing potential must be using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner) Patients aged ≥ 18 years Patients with coronary artery disease confirmed by angiography, prior MI, prior revascularisation (PCI, CABG) and with exercise angina not controlled by the standard therapy ST‐segment depression ≥ 1mm during exercise ECG Capacity to perform the exercise test Able and willing to sign informed consent and to comply with study procedures Females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test Reproducible ST‐segment depression ≥ 1mm during two exercise tests performed 1 week apart (difference in exercise no more than 20%) (at first visit) Exclusion criteria: Angina at rest ECG abnormalities at rest (left bundle‐branch block, resting ST‐segment depression ≥ 1mm, tachyarrhythmia) Presence of factors that preclude satisfactory interpretation of the ECG (e.g. resting ST‐segment depression ≥ 1 mm in any lead, left bundle‐branch block, digoxin therapy) or repolarisation and conduction abnormalities Heart failure (class III or IV NYHA) Moderate‐severe hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg) Hypotension Acute coronary syndrome or coronary revascularisation procedure within the prior 3 months before enrolment Females who are pregnant or nursing Any clinically relevant haematological or biochemical abnormality on routine screening, according to Investigator’s judgment Severe concurrent pathology, including terminal illness (cancer, AIDS, etc.) Renal impairment defined as creatinine clearance< 30 mL/min Mild, moderate or severe hepatic impairment or hepatic insufficiency defined as: SGOT or SGPT > 3 times ULN or total serum bilirubin > 1.5 times greater than normal upper limit Pre‐existing QT prolongation (including congenital long QT syndrome, uncorrected hypokalaemia) Patients on QT‐prolonging drugs such as Class Ia (e.g. quinidine) and Class III (e.g. dofetilide, sotalol, dronedarone) anti‐arrhythmics, and antipsychotics (e.g. thioridazine, ziprasidone) Existing contraindications for exercise testing (e.g. acute myocarditis or pericarditis, DVT, severe aortic stenosis) Dementia, psychosis, alcoholism (>350 g ethanol/week) or chronic abuse of medicines, drugs or psychoactive substances 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
Interventions	Number of intervention groups: 2 Concomitant medications: not described Excluded medications: those mentioned in exclusion criteria Placebo group Intervention: placebo Duration of intervention: 24 weeks Ranolazine group Intervention: ranolazine (type of formulation not specified) 750 mg twice daily Duration of intervention: 24 weeks
Outcomes	Total number of outcomes: 5 (ETT parameters, angina frequency, nitroglycerin consumption frequency, adverse events incidence, laboratory findings) OUTCOMES Angina episodes frequency Outcome definition: weekly frequency Method and unit of measurement: number/week Time points to report: 4, 12 and 24 weeks Adverse events incidence Outcome definition: not described Method and unit of measurement: absolute frequency Time points to report: 4, 12 and 24 weeks
Starting date	Not reported
Contact information	Study Medical Expert (SME) Via Walter Tobagi, 8 Peschiera Borromeo ‐ Italy 003902516555236 dzava@lusofarmaco.it
Notes	Source of funding: Menarini International Operations Luxembourg SA