A Phase 2 interventional study of Ciclosporin and Saline in Myocardial Reperfusion Injury, sponsored by Newcastle-upon-Tyne Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by Newcastle-upon-Tyne Hospitals NHS Trust · Phase 2, Interventional, and Treatment
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.
Coronary heart disease is a condition in which the supply of blood and oxygen to the heart is reduced due to the narrowing of the arteries supplying the heart. A heart attack is caused when one of these arteries becomes blocked. Modern treatment for a heart attack is called primary percutaneous coronary intervention (PPCI). PPCI involves opening the blocked artery with a balloon and placing a stent (a small metal tube) in the artery to hold it open.
Research has shown that after opening the blocked artery, inflammation develops within the heart. This inflammation is generated by the immune system. Initial studies have suggested that certain immune system cells (T-cells) may be involved in causing much of the damage that occurs in the heart following a heart attack. The drug ciclosporin temporarily inhibits the immune system and it has been shown in a small number of patients that it reduces the size of the heart attack. The aim of this clinical trial is to investigate in a larger number of patients whether the size of the heart attack is reduced in patients treated with the drug ciclosporin prior to PPCI relative to patients treated with a placebo (saline).
To participate in the trial you must be having a large heart attack (STEMI - ST segment elevation myocardial infarction) and be undergoing a PPCI to unblock your artery. You must also be aged over 18 years. You will be randomised to receive either a single dose of the drug ciclosporin or placebo before your blocked artery is opened. Half the people will get the drug ciclosporin. This randomisation will enable us to compare the results to see whether treatment with ciclosporin reduces the size of the heart attack compared with placebo.
There may be no immediate benefit from taking part in the trial but the information we get from this trial will help improve the treatment of people having a heart attack in the future. As far as we know there are no disadvantages of taking part in the trial. If you are randomised to the 'drug' group, there is a very small risk of side effects from ciclosporin, such as high blood pressure and slight worsening of kidney function. We do not expect any side effects as the ciclosporin is only given once in the trial. On rare occasions allergic reactions have been observed. If any ciclosporin-related side effects were to occur, they would be expected soon after the drug was administered.
This is a single centre, randomised, double-blind, parallel group, placebo-controlled phase II/III trial comparing the efficacy of ciclosporin versus placebo in 68 patients with acute myocardial infarction undergoing PPCI. The trial is set in a tertiary care centre (Freeman Hospital, Newcastle upon Tyne, UK) and patients will be recruited over a period of 18 months. The trial is designed to show superiority regarding its primary endpoint. During initial hospitalisation following myocardial infarction, treatment is given once prior to performing the PPCI in the catheter laboratory. The duration of study for each patient is 12 months until final follow-up (12 weeks randomised controlled trial (RCT) followed by 9 months study follow-up). Should treatment with ciclosporin look promising, a larger trial will be designed to evaluate ciclosporin treatment fully. In contrast to the previous study, this trial is not restricted to anterior STEMI patients. It will also analyse changes in inflammatory response following reperfusion and will use MRI (current gold standard) in every patient to quantify infarct size, ejection fraction and microvascular obstruction.
271 studies on the registry are indexed under Reperfusion Injury; 42 are open to participants now.
This study's enrollment of 54 is below the median of 61 across 215 interventional studies indexed under Reperfusion Injury.
Browse Reperfusion Injury studies →Newcastle-upon-Tyne Hospitals NHS Trust is the lead sponsor of 65 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Contraindication to cardiac MRI:
Patients unable to undergo cardiac MRI for any of the following reasons:
Single intravenous administration of ciclosporin (2.5mg per kilogram body weight) immediately prior to reperfusion during primary percutaneous coronary intervention. Ciclosporin is dissolved in saline (maximum concentration 2.5mg per millilitre)
Drug: Ciclosporin
Single intravenous administration of placebo (saline) immediately prior to reperfusion during primary percutaneous coronary intervention
Drug: Saline
Comparison between ciclosporin and placebo
Also known as: Sandimmun
Change in infarct size
Change in infarct size 12 weeks post-PPCI as measured by cardiac MRI
Time frame: 12 weeks after primary percutaneous coronary intervention (PPCI)
Change in microvascular obstruction
Microvascular obstruction after 2-7 days as measured by a single cardiac MRI scan
Time frame: Measured once between day 2 and day 7 after PPCI
Change in salvage index
Salvage index after 2-7 days as measured by a single cardiac MRI scan
Time frame: Measured once between day 2 and day 7 after PPCI
Change in T lymphocyte count
Change in T lymphocyte counts relative to baseline at 5, 15, 30, 60 and 90 minutes post-reperfusion
Time frame: 5, 15, 30, 60 and 90 minutes
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Newcastle-upon-Tyne Hospitals NHS Trust