Clinical Trial: Ciclosporin to Reduce Reperfusion Injury in Primary PCI

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Evaluating the Effectiveness of Intravenous Ciclosporin on Reducing Reperfusion Injury in Patients Undergoing Primary Percutaneous Intervention: a Double-blind Randomised Controlled Trial

Brief 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.


Detailed Summary:

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
Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

Current Primary Outcome: Change in infarct size [ Time Frame: 12 weeks after primary percutaneous coronary intervention (PPCI) ]

Change in infarct size 12 weeks post-PPCI as measured by cardiac MRI


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in microvascular obstruction [ Time Frame: Measured once between day 2 and day 7 after PPCI ]
    Microvascular obstruction after 2-7 days as measured by a single cardiac MRI scan
  • Change in salvage index [ Time Frame: Measured once between day 2 and day 7 after PPCI ]
    Salvage index after 2-7 days as measured by a single cardiac MRI scan
  • Change in T lymphocyte count [ Time Frame: 5, 15, 30, 60 and 90 minutes ]
    Change in T lymphocyte counts relative to baseline at 5, 15, 30, 60 and 90 minutes post-reperfusion


Original Secondary Outcome: Same as current

Information By: Newcastle-upon-Tyne Hospitals NHS Trust

Dates:
Date Received: March 11, 2015
Date Started: March 2015
Date Completion: January 2018
Last Updated: March 29, 2017
Last Verified: March 2017