Clinical trial NCT02390674 (phase 2, status: completed)
Conditions: myocardial reperfusion injury
ICD codes: I51.5, I25.2, I25.6, I21.9, I21.A1, I21.A9, P29.4
Drugs: ciclosporin, saline
SMILES: CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C, COCCC1=CC=C(OCC(O)CNC(C)C)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting with acute myocardial infarction (STEMI) and undergoing primary
             percutaneous coronary intervention (PPCI)

          -  Age above 18 years

          -  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

        Exclusion Criteria:

          -  Patients with any disorder associated with immunological dysfunction (acute or chronic
             inflammatory or neoplastic co-existing disease, known positive serology for HIV, or
             hepatitis)

          -  Clinically unstable patients (haemodynamically unstable, cardiogenic shock,
             unconscious patients)

          -  Patients with evidence of coronary collaterals to the infarct area

          -  Patients with an open (TIMI > 1) culprit coronary artery at the time of angiography.

          -  Previous myocardial infarction

          -  Previous thrombolytic therapy

          -  Patients with known hypersensitivity to ciclosporin or to egg, peanut or soya-bean
             proteins.

          -  Patients with known renal insufficiency (either known glomerular filtration rate (GFR)
             <30 ml/min/1.73m2) or current medical care for severe renal insufficiency.

          -  Known liver insufficiency

          -  Uncontrolled hypertension (>180/110 mmHg)

          -  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.

          -  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 investigational
             medicinal product (IMP) administration).

          -  Contraindication to cardiac MRI:

               -  Pacemaker

               -  Implantable defibrillator

          -  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).

          -  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.

          -  Lack of capacity to give initial verbal consent

          -  Life expectancy <1year due to non-cardiac illness