Myocardial StunningPhase 4NCT02687269
Ranolazine a Potential New Therapeutic Application
A Phase 4 study testing Ranolazine in people with Myocardial Stunning, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Despite surgical and medical innovation have reduced mortality rates in cardiac surgery, the disease severity and operative procedural complexity have increased and morbidity rate is still high. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Stunning
- What is being tested?
- Ranolazine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2019to Oct 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- sinus rhythm, heart rate (FC) ≥ 50 bpm at rest;
- NYHA class I, II, III (CCS I, II, III);
Who cannot join
- 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;
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- 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
About this study
Official title: Ranolazine Myocardial Protection in Complete Coronary Artery Bypass Grafting: A Randomized-controlled Trial
Despite surgical and medical innovation have reduced mortality rates in cardiac surgery, the disease severity and operative procedural complexity have increased and morbidity rate is still high. Ischemia-reperfusion (I/R) injury, redefined in cardiac surgery "post-cardioplegic injury" (2) as a whole of ischemia-reperfusion, cardiopulmonary bypass and surgical trauma, has been recognized as a significant contributor to mortality and morbidity. I/R injury is classified as reversible or irreversible. Reversible injury includes arrhythmias, edema, vascular dysfunction and contractile stunning expressed as low output syndrome without cell death and without apparent signs of infarction or other serum injury markers. Irreversible reperfusion injury includes apoptosis and necrosis. I/R injury is a complex process associated with increase of radical, oxidant and cytokines production, complement and neutrophil activation and endothelial activation leading to microvascular dysfunction and deterioration of coronary flow reserve. In the hypoxic heart increase anaerobic lactate production, K+ efflux and membrane depolarization. The intracellular Na+ concentration rises as a consequence of slow Na+ channels inactivation and the induction of voltage-gated Na+ channel late current component (late INA). Intracellular Na++ accumulation enhanced activity of reversed-mode Na+-Ca++ exchanger causing intracellular Ca++ overload and ventricular dysfunction. Therefore inhibition of late INA has been shown to be cardioprotective. Ranolazine, an FDA-approval antianginal and anti-ischemic agent, high selective blocker of late INA, inhibits the late sodium current in myocardial ischemia, decreases Na+ and Ca2+ overload and improves left ventricular function in experimental animal models. For this reason it was also adjuncted to cardioplegia improving diastolic function in isolate Langerdoff-perfused rat hearts. The authors test the hypothesis that ranolazine improve myocardical protection in patients undergoing coronary artery surgery with cardiopulmonary by-pass (CPB).
Read the detailed description
We aim to perform a prospective, single-center, investigator-initiated, randomized (1:1), blinded, placebo-controlled study. 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 or placebo. After the enrollement in the research according the inclusion and exclusion criteria, the randomization list will be computer-generated. The study participants, the reserchers responsible for data reporting and analysis and the ecocardiographers will be blinded to the treatment that each patient will receive. In a previous phase all data for the recruitment will be considered and registered before surgery: basic clinical parameters (age, gender, height, weight, body surface, systolic blood pressure and diastolic blood pressure, mean heart rate); medical history (diabetes mellitus type I or II, smoking status, chronic obstructive pulmonary desease, systemic arterial hypertension, dyslipidemia, family history of cardiovascular events, angina, percutaneous coronary interventions (PCI), acute myocardial infarction (AMI), previous cardiac surgery, chronic peripheral arterial disease, cerebral ischemia, bleeding and chronic renal failure); basic hematologic parameters (creatinine, glucose, hemoglobin, hematocrit, white blood cell counts and equation, platelets number, aPTT, INR); baseline transthoracic echocardiographic (TTE) parameters (left ventricular ejection function (LVEF), left ventricular volumes, left ventricular regional wall motion, diastolic function (mitral inflow velocities as Early diastolic velocity (E), late diastolic velocity with atrial contraction (A), and deceleration time (DT), early diastolic velocity (e') and late diastolic velocity with atrial contraction (a') using tissue Doppler imaging, pulmonary artery systolic pressure (PASP), valvulopathy and aortic desease); assestment of risk stratification according to different scores (New York Heart Association (NYHA) classes, Canadian Cardiovascular Society (CCS) Angina grading scale, EUROSCORE II, American Society og Anesthesiologists (ASA) physical status classification system); preoperative patient therapy. In a following phase laboratory, hemodynamic and imaging evaluation will be carried out during and subsequent to CABG surgery. Through a coronary sinus inserted catheter will be dosed Troponine I (TnI) immediately before CPB and after the release of aortic cross clamp, about 10 minutes after the end of reperfusion. TnI will be also dosed at arrival on intensive care unit and 6, 12, 24, 48 h after unclamping of the aorta. Blood samples will be collected simultaneously from the radial artery and the coronary sinus before starting CPB and after removal of aortic cross clamp to evaluate lactates extraction, oxygen consumption (VO2) and oxygen extraction (O2ER), and C-reactive protein (CRP) pre and post-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); these measurements will be conducted 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. Lastly a transesophageal echocardiographic study will be performed by two expert echocardiographers following the protocols of the Society of Cardiovascular Anesthesiologists (21) and American Society of Echocardiography (22). 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 30 minute after intubation before sternotomy and ten minute after protamin. All collected data will be entered into a database in Excel format.
- Conditions
- Myocardial Stunning
- Being tested
- Ranolazine, Placebo
- Keywords
- myocardial protection, coronary artery bypass grafting
- Medical subject headings
- Myocardial Stunning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Also called Ranexa
Patients in this arm receive Ranolazine at a dose of 375 mg twice daily in the three days before surgery
PlaceboDrug
Patients receive Placebo twice daily in the three days before surgery
| Study group | Role | What they receive |
|---|---|---|
| Ranolazine | Experimental | 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. Receives: Drug: Ranolazine |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponins I variation collected by coronary sinus pre and post clamping of the aorta.
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.
Measured: Before cardiopulmonary by-pass and 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.
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.
Measured: Before cardiopulmonary by-pass and 10 minutes after the end of reperfusion
Lactates variation collected by the radial artery and coronary sinus pre and post clamping of the aorta.
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.
Measured: Before cardiopulmonary by-pass and 10 minutes after the end of reperfusion
Troponins I variation collected by blood sample
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.
Measured: Since arrival on intensive care unit and 6, 12, 24, 48 h after unclamping of the aorta
Secondary outcomes (3)
Echocardiographic evaluation to assess significant differences in terms of systolic and diastolic left ventricular function post cardiopulmonary by-pass.
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.
Measured: 30 minute after intubation before sternotomy and ten minute after protamin
Hemodynamic measurements
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).
Measured: 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
Cardiac Complications
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.
Measured: Since arrival on intensive care unit and 6, 12, 24, 48 h after unclamping of the aorta
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study start10 Apr 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: Inability to produce placebo tablets similar to the drug tested
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial StunningStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Temistocle Taccheri, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Gabriella Arlotta, MD, Study director, Department cardiovascular diseases A. Gemelli Polyclinic , University Sacred Heart in Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687269
- Sponsor's protocol ID
- RAN
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2016
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranolazine Myocardial Protection in Complete Coronary Artery Bypass Grafting: A Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT02687269
- Acronym / sponsor ID
- RAN
- Conditions
- Myocardial Stunning
- Keywords
- myocardial protection, coronary artery bypass grafting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to produce placebo tablets similar to the drug tested
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 10 Apr 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite surgical and medical innovation have reduced mortality rates in cardiac surgery, the disease severity and operative procedural complexity have increased and morbidity rate is still high. Ischemia-reperfusion (I/R) injury, redefined in cardiac surgery "post-cardioplegic injury" (2) as a whole of ischemia-reperfusion, cardiopulmonary bypass and surgical trauma, has been recognized as a significant contributor to mortality and morbidity. I/R injury is classified as reversible or irreversible. Reversible injury includes arrhythmias, edema, vascular dysfunction and contractile stunning expressed as low output syndrome without cell death and without apparent signs of infarction or other serum injury markers. Irreversible reperfusion injury includes apoptosis and necrosis. I/R injury is a complex process associated with increase of radical, oxidant and cytokines production, complement and neutrophil activation and endothelial activation leading to microvascular dysfunction and deterioration of coronary flow reserve. In the hypoxic heart increase anaerobic lactate production, K+ efflux and membrane depolarization. The intracellular Na+ concentration rises as a consequence of slow Na+ channels inactivation and the induction of voltage-gated Na+ channel late current component (late INA). Intracellular Na++ accumulation enhanced activity of reversed-mode Na+-Ca++ exchanger causing intracellular Ca++ overload and ventricular dysfunction. Therefore inhibition of late INA has been shown to be cardioprotective. Ranolazine, an FDA-approval antianginal and anti-ischemic agent, high selective blocker of late INA, inhibits the late sodium current in myocardial ischemia, decreases Na+ and Ca2+ overload and improves left ventricular function in experimental animal models. For this reason it was also adjuncted to cardioplegia improving diastolic function in isolate Langerdoff-perfused rat hearts. The authors test the hypothesis that ranolazine improve myocardical protection in patients undergoing coronary artery surgery with cardiopulmonary by-pass (CPB).
Detailed description
We aim to perform a prospective, single-center, investigator-initiated, randomized (1:1), blinded, placebo-controlled study. 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 or placebo. After the enrollement in the research according the inclusion and exclusion criteria, the randomization list will be computer-generated. The study participants, the reserchers responsible for data reporting and analysis and the ecocardiographers will be blinded to the treatment that each patient will receive. In a previous phase all data for the recruitment will be considered and registered before surgery: basic clinical parameters (age, gender, height, weight, body surface, systolic blood pressure and diastolic blood pressure, mean heart rate); medical history (diabetes mellitus type I or II, smoking status, chronic obstructive pulmonary desease, systemic arterial hypertension, dyslipidemia, family history of cardiovascular events, angina, percutaneous coronary interventions (PCI), acute myocardial infarction (AMI), previous cardiac surgery, chronic peripheral arterial disease, cerebral ischemia, bleeding and chronic renal failure); basic hematologic parameters (creatinine, glucose, hemoglobin, hematocrit, white blood cell counts and equation, platelets number, aPTT, INR); baseline transthoracic echocardiographic (TTE) parameters (left ventricular ejection function (LVEF), left ventricular volumes, left ventricular regional wall motion, diastolic function (mitral inflow velocities as Early diastolic velocity (E), late diastolic velocity with atrial contraction (A), and deceleration time (DT), early diastolic velocity (e') and late diastolic velocity with atrial contraction (a') using tissue Doppler imaging, pulmonary artery systolic pressure (PASP), valvulopathy and aortic desease); assestment of risk stratification according to different scores (New York Heart Association (NYHA) classes, Canadian Cardiovascular Society (CCS) Angina grading scale, EUROSCORE II, American Society og Anesthesiologists (ASA) physical status classification system); preoperative patient therapy. In a following phase laboratory, hemodynamic and imaging evaluation will be carried out during and subsequent to CABG surgery. Through a coronary sinus inserted catheter will be dosed Troponine I (TnI) immediately before CPB and after the release of aortic cross clamp, about 10 minutes after the end of reperfusion. TnI will be also dosed at arrival on intensive care unit and 6, 12, 24, 48 h after unclamping of the aorta. Blood samples will be collected simultaneously from the radial artery and the coronary sinus before starting CPB and after removal of aortic cross clamp to evaluate lactates extraction, oxygen consumption (VO2) and oxygen extraction (O2ER), and C-reactive protein (CRP) pre and post-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); these measurements will be conducted 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. Lastly a transesophageal echocardiographic study will be performed by two expert echocardiographers following the protocols of the Society of Cardiovascular Anesthesiologists (21) and American Society of Echocardiography (22). 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 30 minute after intubation before sternotomy and ten minute after protamin. All collected data will be entered into a database in Excel format.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranolazine | Experimental | Drug: RanolazineThe 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. |
| Placebo | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18 years
- sinus rhythm, heart rate (FC) ≥ 50 bpm at rest;
- NYHA class I, II, III (CCS I, II, III);
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanolazineAlso: RanexaPatients in this arm receive Ranolazine at a dose of 375 mg twice daily in the three days before surgery | Drug | Ranolazine |
| PlaceboPatients receive Placebo twice daily in the three days before surgery | Drug | Placebo |
Primary outcome
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.
3 secondary outcomes
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
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
Cardiac Complications
Time frame: Since arrival on intensive care unit and 6, 12, 24, 48 h after unclamping of the aorta
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriella Arlotta, MD study director
Department cardiovascular diseases A. Gemelli Polyclinic , University Sacred Heart in Rome
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranolazine in people with Myocardial Stunning, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.