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    Summary
    EudraCT Number:2020-004877-38
    Sponsor's Protocol Code Number:PREVENT-MINS
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-01-18
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-004877-38
    A.3Full title of the trial
    Ivabradine for PREVENTion of Myocardial Injury after Noncardiac Surgery (MINS) - PREVENT-MINS Trial
    Iwabradyna w prewencji okołozabiegowego uszkodzenia mięśnia sercowego po zabiegach niekardiochirurgicznych - badanie PREVENT-MINS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ivabradine for PREVENTion of Myocardial Injury after Noncardiac Surgery (MINS) - PREVENT-MINS Trial
    A.3.2Name or abbreviated title of the trial where available
    PREVENT-MINS
    A.4.1Sponsor's protocol code numberPREVENT-MINS
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniwersytet Jagielloński - Collegium Medicum
    B.1.3.4CountryPoland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAgencja Badań Medycznych
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniwersytet Jagielloński Collegium Medicum
    B.5.2Functional name of contact pointWojciech Szczeklik
    B.5.3 Address:
    B.5.3.1Street AddressŚw. Anny 12
    B.5.3.2Town/ cityKraków
    B.5.3.3Post code31-008
    B.5.3.4CountryPoland
    B.5.4Telephone number0048501 426 864
    B.5.6E-mailwojciech.szczeklik@uj.edu.pl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ivabradine Anpharm
    D.2.1.1.2Name of the Marketing Authorisation holderANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIvabradine
    D.3.9.1CAS number 148849-67-6
    D.3.9.3Other descriptive nameIVABRADINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB22933
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Myocardial Injury after Noncardiac Surgery
    E.1.1.1Medical condition in easily understood language
    Myocardial Injury after Noncardiac Surgery
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028601
    E.1.2Term Myocardial ischemia
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of perioperative administration of ivabradine in patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery. Primary Objectives:
    To determine the effect of perioperative administration of ivabradine in patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery. The primary outcome is myocardial injury after non-cardiac surgery (MINS) defined as any myocardial infarction and any elevated postoperative cardiac troponin judged as resulting from myocardial ischaemia during or within 30 days after noncardiac surgery
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    To determine the impact of ivabradine on the following outcomes at 30 days after surgery: a composite of vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest; vascular death;
    MINS not fulfilling the criteria of myocardial infarction; myocardial infarction; peak troponin concentration; area under the curve troponin; days alive and at home; stroke; all-cause mortality; health-related quality of life; cancellation/postponement of surgery on the day of surgery due to HR concerns; clinically important atrial fibrillation; safety outcomes including clinically significant bradycardia, clinically significant hypotension and phosphenes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    Patients are eligible for the study if they fulfill the following criteria for inclusion:
    1. Undergoing noncardiac surgery;
    2. ≥45 years of age;
    3. Expected to require at least an overnight hospital stay after surgery;
    4. Written informed consent to participate in the PREVENT-MINS Trial provided,
    AND
    5. Fulfill ≥1 of the following 5 criteria (A-E):
    A. Current or prior history of coronary artery disease as defined by any one of the following 7 criteria:
    i. History of angina;
    ii. History of acute coronary syndrome;
    iii. History of a segmental cardiac wall motion abnormality on echocardiography or a segmental fixed defect on radionuclide imaging;
    iv. History of a positive radionuclide exercise, echocardiographic exercise, or pharmacological cardiovascular stress test demonstrating cardiac ischaemia;
    v. History of a coronary angiographic or CT coronary angiographic evidence of atherosclerotic stenosis ≥50% of the diameter of any coronary artery;
    vi. ECG with pathological Q waves in at least two contiguous leads; OR
    vii. Previous coronary artery revascularization, (i.e. percutaneous coronary intervention [PCI] or coronary artery bypass graft surgery [CABG]);
    B. Peripheral arterial disease as defined by a physician diagnosis of a current, or prior history of any of the following 4 criteria:
    i. Intermittent claudication;
    ii. Vascular surgery OR percutaneous transluminal angioplasty (PTA) for atherosclerotic disease;
    iii. An ankle/brachial systolic blood pressure ratio <0.90 in either leg at rest; OR
    iv. Angiographic, CT angiographic or doppler findings demonstrating >70% stenosis in a noncardiac artery;
    C. History of stroke as defined by any one of the following 2 criteria
    i. A physician diagnosis of stroke; OR
    ii. CT or MRI evidence of a prior stroke;
    D. Undergoing major vascular surgery defined as all vascular surgeries (including any above foot amputation) with the exception of arteriovenous shunt, vein stripping procedures (varicose vein surgery), carotid endarterectomies, endovascular abdominal aortic aneurysm repair (EVAR); OR
    E. Any 3 of 9 risk criteria:
    i. Undergoing major surgery defined as: intraperitoneal, intrathoracic, retroperitoneal, or major orthopedic;
    ii. History of congestive heart failure defined as a physician diagnosis of a current or prior episode of congestive heart failure OR prior radiographic evidence of vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema;
    iii. History of a transient ischaemic attack;
    iv. Diabetes diagnosis and currently taking hypoglycemic agent;
    v. Age ≥70 years;
    vi. History of hypertension;
    vii. Serum creatinine >175 μmol/L (>2.0 mg/dl) based on the most recent values before randomisation;
    viii. History of smoking within 2 years of surgery; and
    ix. Undergoing emergent/urgent surgery, defined as surgery that a surgeon schedules to go to the operating room within 48 hours from an acute presentation to the hospital.
    E.4Principal exclusion criteria
    Exclusion criteria
    1. Conduction abnormalities:
    A. Non-sinus rhythm on ECG;
    B. Sinoatrial or AV (2nd and 3d degree) blocks;
    C. Sick sinus syndrome;
    D. Long QT syndrome;
    E. Pacemaker dependent;
    2. Transplanted heart (or on waiting list);
    3. Use of a selected class I or III antiarrhythmic drug (quinidine, disopyramide, sotalol, ibutilide, amiodarone) or diltiazem/verapamil;
    4. Resting heart rate <65 beats per minute on the day of surgery;
    5. Systolic blood pressure <90 mmHg on the day of surgery;
    6. Acute decompensated heart failure, cardiogenic shock, acute myocarditis;
    7. Acute coronary syndrome within 2 months before surgery;
    8. Stroke or transient cerebral ischaemia within 1 month before surgery;
    9. Known severe liver or kidney disease (MDRD creatinine clearance <15 mL/min);
    10. Inability to tolerate oral intake;
    11. Recent use of ivabradine (<1 month);
    12. Known allergy or hypersensitivity to ivabradine;
    13. Low-risk surgical procedure based on individual physician's judgment
    14. Investigator considers the patient unreliable regarding requirement for study compliance;
    15. Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding;
    16. Previously enrolled in the PREVENT-MINS trial.
    E.5 End points
    E.5.1Primary end point(s)
    Evidence of a dynamic troponin elevation defined as follows:
    1. a non-high-sensitivity troponin T ≥30 ng/L with an at least 15 ng/L change;
    2. a high-sensitivity troponin T (hsTnT) level ≥20 with an absolute change of at least 5 ng/L;
    3. an Abbott high-sensitivity troponin I (hsTnI) level ≥60 ng/L and a change of ≥50% of the 99th percentile upper reference limit;
    4. a Siemens hsTnI level ≥75 ng/L and a change of ≥50% of the 99th percentile upper reference limit;
    5. for any other hsTnI or non-hsTnI as any value above the 99th percentile upper reference limit for each specific troponin I assay and a change of ≥50% of the 99th percentile upper reference limit.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before surgery, at postoperative day 1, 2, 3 or until hospital discharge, if hospital discharge occurs sooner than 3 days after surgery, and at Day 30 on-site follow-up visit.
    E.5.2Secondary end point(s)
    Safety assessment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Day 30 on-site and Year 1 telephone follow-up visits.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned25
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1250
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2500
    F.4.2.2In the whole clinical trial 2500
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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