Ranolazine a Potential New Therapeutic Application
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ClinicalTrials.gov Identifier: NCT02687269 |
Recruitment Status :
Withdrawn
(Inability to produce placebo tablets similar to the drug tested)
First Posted : February 22, 2016
Last Update Posted : February 25, 2021
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Condition or disease | Intervention/treatment | Phase |
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Myocardial Stunning | Drug: Ranolazine Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Ranolazine Myocardial Protection in Complete Coronary Artery Bypass Grafting: A Randomized-controlled Trial |
Estimated Study Start Date : | April 10, 2019 |
Estimated Primary Completion Date : | September 2020 |
Estimated Study Completion Date : | October 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Ranolazine
The patients undergoing elective and complete CABG revascularization performed by the same surgeon, will be randomized in two different groups to receive, in the three days before surgery, Ranolazine at a dose of 375 mg twice daily.
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Drug: Ranolazine
Patients in this arm receive Ranolazine at a dose of 375 mg twice daily in the three days before surgery
Other Name: Ranexa |
Placebo Comparator: Placebo
The patients undergoing elective and complete CABG revascularization performed by the same surgeon, will be randomized in two different groups to receive, in the three days before surgery, placebo twice daily.
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Drug: Placebo
Patients receive Placebo twice daily in the three days before surgery |
- Troponins I variation collected by coronary sinus pre and post clamping of the aorta. [ Time Frame: Before cardiopulmonary by-pass and 10 minutes after the end of reperfusion ]A blood sample will be collected by coronary sinus and the sample sent by our laboratories to assess the concentration in µg/l of cardiac troponins directly in venous blood before cardiopulmonary by-pass and after the release of aortic cross clamp, about 10 minutes after the end of reperfusion.
- Myocardial VO2 and O2 extraction variation collected by radial artery and coronary sinus pre and post clamping of the aorta. [ Time Frame: Before cardiopulmonary by-pass and 10 minutes after the end of reperfusion ]Earlobe arterialized blood sample will be collected by radial artery coronary sinus and the sample sent by our laboratories to assess the concentration of VO2 and O2ER in ml/min in venous blood before cardiopulmonary by-pass and after the release of aortic cross clamp, about 10 minutes after the end of reperfusion.
- Lactates variation collected by the radial artery and coronary sinus pre and post clamping of the aorta. [ Time Frame: Before cardiopulmonary by-pass and 10 minutes after the end of reperfusion ]Earlobe arterialized blood sample will be collected by radial artery and coronary sinus and the sample sent by our laboratories to assess the concentration of lactates in mmol/L in venous blood before cardiopulmonary by-pass and after the release of aortic cross clamp, about 10 minutes after the end of reperfusion.
- Troponins I variation collected by blood sample [ Time Frame: Since arrival on intensive care unit and 6, 12, 24, 48 h after unclamping of the aorta ]A blood sample will be collected by peripheral vein and the sample sent by our laboratories to assess the concentration in µg/l of cardiac troponins Since arrival on intensive care unit and 6, 12, 24, 48 h after unclamping of the aorta.
- Echocardiographic evaluation to assess significant differences in terms of systolic and diastolic left ventricular function post cardiopulmonary by-pass. [ Time Frame: 30 minute after intubation before sternotomy and ten minute after protamin ]Transesophageal echocardiographic study will be performed by two expert echocardiographers following the protocols of the Society of Cardiovascular Anesthesiologists and American Society of Echocardiography. Left ventricle myocardial performance index, LVEF (%), left ventricular regional wall motion, E/A ratio, E', E/E' and deceleration time (DT) of mitral inflow velocity will be measured; these measurements will be obteined.
- Hemodynamic measurements [ Time Frame: 30 min after intubation, after sternotomy, 10 min after protamin, after sternosynthesis, at arrival in the intensive care unit, 6, 12, 24, 36, 48 h after CPB ]Hemodynamic measurements will be obtained by an arterial and a pulmonary artery catheter (PAC) inserted before surgery, and will include arterial pressure (systolic, diastolic and mean pressure), pulmonary artery pressure (PAP), right atrial pressure (RAP), pulmonary artery wedge pressure (PAWP), cardiac output (CO) and cardiac index (CI), systemic vascular resistance (SVR), left ventricular stroke work (LVSW), left stroke volume variaton (LSVV) and coronary artery perfusion pressure (CPP).
- Cardiac Complications [ Time Frame: Since arrival on intensive care unit and 6, 12, 24, 48 h after unclamping of the aorta ]New-onset atrial fibrillation, ventricular arrhythmia, low cardiac output syndrome (LCOS), inotropic support and/or intraaortic balloon pump >24 hours, myocardial infarction) and intensive care unit and hospital length of stay between two groups.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age ≥ 18 years
- sinus rhythm, heart rate (FC) ≥ 50 bpm at rest;
- NYHA class I, II, III (CCS I, II, III);
Exclusion Criteria:
- drugs intolerance or hypersensitivity;
- cardiogenic shock;ejection fraction (FE ) ≤ 50 % ;
- NYHA class IV (CCS IV);
- II or III atrioventricular block;
- a resting heart rate (HR) < 50 bpm or sick sinus syndrome;
- rate-corrected QT interval (QTc) greater than 500 ms;
- age <18 years;
- symptomatic hypotension or uncontrolled hypertension (systolic blood pressure at rest ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg);
- severe liver disease
- severe renal impairment (creatinine clearance ≤ 30 ml/min);
- from moderate to severe electrolyte disorders (potassium concentration < 2,5 or > 6 mmol/L; calcium concentration < 8 or > 11 mg/dl; magnesium < 1,8 or > 2,5 mg/dl);
- pregnancy;
- concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone)
- concomitant administration of Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone;
- previous cardiac interventions

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687269
Study Director: | Gabriella Arlotta, MD | Department cardiovascular diseases A. Gemelli Polyclinic , University Sacred Heart in Rome |
Responsible Party: | Temistocle Taccheri, MD, Resident in Anesthesia and Intensive Care Department, Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
ClinicalTrials.gov Identifier: | NCT02687269 |
Other Study ID Numbers: |
RAN |
First Posted: | February 22, 2016 Key Record Dates |
Last Update Posted: | February 25, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
myocardial protection coronary artery bypass grafting |
Myocardial Stunning Heart Diseases Cardiovascular Diseases Ranolazine |
Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |