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    Summary
    EudraCT Number:2014-002628-29
    Sponsor's Protocol Code Number:R&D6327
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-04
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2014-002628-29
    A.3Full title of the trial
    Evaluating the effectiveness of intravenous ciclosporin on reducing reperfusion injury in patients undergoing primary percutaneous coronary intervention: a double-blind, phase II, randomised controlled trial (CAPRI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ciclosporin to reduce damage to the heart during routine treatment for a heart attack (CAPRI)
    A.3.2Name or abbreviated title of the trial where available
    Ciclosporin to reduce reperfusion injury in primary PCI (CAPRI)
    A.4.1Sponsor's protocol code numberR&D6327
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN27767229
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02390674
    A.5.4Other Identifiers
    Name:REC referenceNumber:13/NE/1070
    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 SponsorNewcastle upon Tyne Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportNIHR Newcastle Biomedical Research Centre
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNewcastle University
    B.5.2Functional name of contact pointProfessor Ioakim Spyridopoulos
    B.5.3 Address:
    B.5.3.1Street AddressInstitute of Genetic Medicine, Newcastle University, Central Parkway
    B.5.3.2Town/ cityNewcastle upon Tyne
    B.5.3.3Post codeNE1 3BZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01912418675
    B.5.5Fax number01912418666
    B.5.6E-mailioakim.spyridopoulos@ncl.ac.uk
    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 Sandimmun (concentrate for solution for infusion 50mg/ml)
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharmaceuticals UK limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product nameN/A
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNciclosporin
    D.3.9.1CAS number 59865-13-3
    D.3.9.3Other descriptive namecyclosporin A, cyclosporine
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Myocardial ischemia/reperfusion injury
    E.1.1.1Medical condition in easily understood language
    Heart attack
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Routine angioplasty treatment for a heart attack involves opening a blocked artery with a balloon then inserting a small metal scaffold (stent) to hold the artery open. During this procedure inflammation can occur causing further damage to the heart. The objective of this trial is determine whether administration of the drug ciclosporin at the start of the angioplasty procedure reduces the amount of damage to the heart. The damage to the heart will be assessed after 12 weeks by an MRI scan.
    E.2.2Secondary objectives of the trial
    1) To determine the effect of the drug ciclosporin given prior to restoring blood flow to the heart by primary angioplasty on microvascular obstruction (blocked arteries) relative to treatment with a 'dummy' drug (placebo). This will be assessed from a cardiac MRI scan taken after 2-7 days.

    2) To determine the effect of the drug ciclosporin given prior to restoring blood flow to the heart by primary angioplasty on the size of the heart attack relative to treatment with a 'dummy' drug (placebo). This will be assessed from a cardiac MRI scan taken after 2-7 days.

    3) To determine the effect of the drug ciclosporin given to patients prior to restoring blood flow to the heart by angioplasty on inflammation (T-cell count) relative to treatment with a 'dummy' drug (placebo). T-cells will be measured in blood samples taken at 0, 5, 15, 30 and 90 minutes after blood flow has been restored.

    4)To determine the effect of the drug ciclosporin given prior to restoring blood flow to the heart b
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients presenting with acute myocardial infarction (STEMI) and undergoing primary percutaneous coronary intervention (primary PCI)
    2. Age above 18 years
    3. Presenting within 6 hours of the onset chest pain and ST segment elevation. The culprit coronary artery has to be a major coronary artery with a diameter of at least 3mm and has to be proximally occluded (TIMI flow grade 0-1) at the time of admission coronary angiography
    E.4Principal exclusion criteria
    1. Patients with any disorder associated with immunological dysfunction (acute or chronic inflammatory or neoplastic co-existing disease, known positive serology for HIV, or hepatitis)
    2. Clinically unstable patients (haemodynamically unstable, cardiogenic shock, unconscious patients)
    3. Patients with evidence of coronary collaterals to the infarct area
    4. Patients with an open (TIMI > 1) culprit coronary artery at the time of angiography.
    5. Previous myocardial infarction
    6. Previous thrombolytic therapy
    7. Patients with known hypersensitivity to ciclosporin or to egg, peanut or soya-bean proteins.
    8. Patients with known renal insufficiency (either known GFR <30 ml/min/1.73m2) or current medical care for severe renal insufficiency.
    9. Known liver insufficiency
    10. Uncontrolled hypertension (>180/110 mmHg)
    11. Patients treated with any compound containing hypericum perforatum, stiripentol, Aliskiren, Bosentan or Rosuvastatin or with an active treatment that might modify blood concentration of ciclosporin.
    12. Female patients currently pregnant or women of childbearing age who are not using contraception (verbal diagnosis). Female patients of childbearing potential who are using contraception but are subsequently found to have a positive urine pregnancy test (pregnancy test performed as soon as reasonably practicable after IMP administration).
    13. Contraindication to cardiac MRI:
    - Pacemaker
    - Implantable defibrillator
    14. Patients unable to undergo cardiac MRI for any of the following reasons:
    - Frailty – as judged by the clinician. Frailty is defined as meeting three out of the five following criteria: low grip strength, low energy, slowed walking speed, low physical activity and/or unintentional weight loss. Due to the tight time constraints and emergency setting of this trial the clinician cannot test all these parameters and will need to exercise their judgment.
    - Claustrophobic - patients who cannot take elevators or who are afraid of narrow or enclosed spaces.
    - Breathlessness - patients who suffer from breathlessness at rest or low exercise level (e.g. while walking on the level).
    15. Use of other investigational study drugs within 30 days prior to trial entry (defined as date of randomisation into trial). Co-enrolment with other studies is not allowed.
    16. Lack of capacity to give initial verbal consent
    17. Life expectancy <1year due to non-cardiac illness
    E.5 End points
    E.5.1Primary end point(s)
    Infarct size at 12 weeks post-PPCI as measured by cardiac resonance imaging (MRI). Infarct size will be calculated as the percent of infarcted myocardium per left ventricular (LV) mass.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12-weeks post-PPCI
    E.5.2Secondary end point(s)
    1. Microvascular obstruction after 2-7 days as measured by a single cardiac MRI scan
    2. Salvage index after 2-7 days as measured by a single cardiac MRI scan
    3. Change in T lymphocyte counts relative to baseline at 5, 15, 30 and 90 minutes post-reperfusion
    4. Number of clinical events (all cause deaths, stroke or myocardial infarction) after 12 months
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Timepoint of single cardiac MRI scan taken between 2 and 7 days post-PPCI
    2. Timepoint of single cardiac MRI scan taken between 2 and 7 days post-PPCI
    3. 5, 15, 30 and 90 minutes post-reperfusion
    4. 12 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    The end of randomised controlled trial (RCT) will be the last assessment of the last participant at 12 weeks. The end of the study will be the last participant's final study contact (telephone interview) scheduled for 9 months after the 12 week RCT.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days17
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 41
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    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 state68
    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)
    Not appropriate as the ciclosporin is only administered once during the PPCI.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-11
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