Ciclosporin to Reduce Reperfusion Injury in Primary PCI

• Status: Completed
• Trial end date: 2017-11-11
• Target enrollment: 0
• Participant gender: All

Summary

Routine primary percutaneous coronary intervention (PPCI) for a heart attack involves opening a blocked artery with a balloon then inserting a 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 to determine whether administration of the drug ciclosporin prior to PPCI reduces the amount of damage to the heart relative to treatment with placebo. The damage to the heart is assessed after 12 weeks by an magnetic resonance imaging (MRI) scan. Patients are followed-up after 12 months participation in the study.

This is a single centre study looking to recruit 68 patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Collaborators: National Institute for Health Research, United Kingdom; Newcastle University
• Treatments: Cyclosporine; Cyclosporins

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