Double blind, placebo controlled randomised trial assessing the efficacy of endothelin-1 receptor antagonism in the prevention of microvascular injury in patients with non-ST elevation acute coronary syndrome (NSTEACS) undergoing percutaneous coronary intervention: the ENDORA-PCI trial
Double blind, placebo controlled randomised trial assessing the efficacy of endothelin-1 receptor antagonism against placebo in the prevention of microvascular injury in patients with non-ST elevation acute coronary syndrome (NSTEACS) undergoing percutaneous coronary intervention: the ENDORA-PCI trial
Prince of Wales Hospital
52 participants
Feb 16, 2015
Interventional
Conditions
Summary
Coronary artery disease affects around 1.4 million Australians, and represents one of the most significant causes of death and disability in Australia and worldwide. Over the last two decades the focus in the treatment of coronary artery disease has primarily been on blood vessels of large calibre. However, it is becoming increasingly apparent that small vessels within the heart muscles, which are the main determinant of blood supply to the heart, may in fact have an equally important, if not more dominant role to play in patients with heart attacks or angina. It has also been suggested that small vessel problems may also be responsible for injury to the heart muscle during a stenting procedure, a potentially serious problem which remains a common issue despite recent technological advancement. Currently the understanding of these small vessels and treatment options are limited. This project aims to investigate the role of these small vessels in heart muscle injury during a stenting procedure and elucidate the possible mechanisms which predispose to or cause dysfunction within these small vessels. I also hope to find a treatment strategy which may benefit patients with small vessel problems and thus improve their overall outcome. If successful, I believe the results will have a wide reaching effect in patients with heart attacks, as well as in an emerging group of patients with angina secondary to small vessel dysfunction, which is resistant to conventional therapies.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Ambrisentan, endothelin receptor antagonist, oral tablet, 10mg daily Patients randomised to the ambrisentan arm will be given 10mg of ambrisentan along with standard medical therapy immediately after randomisation. Further doses of ambrisentan will be administered if the standard dosing interval (24 hours) is exceeded between the preceding dose and planned PCI. The total dose of medications given to the patients will be dictated by the number of days between patients' initial presentation and their PCI procedure. There is no set maximum of total dose.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12615000709549