RecruitingPhase 3ACTRN12615000709549

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


Sponsor

Prince of Wales Hospital

Enrollment

52 participants

Start Date

Feb 16, 2015

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called ambrisentan, which blocks a protein called endothelin-1, can protect the small blood vessels of the heart during a coronary stenting procedure (PCI) in patients with a type of heart attack called non-ST elevation acute coronary syndrome (NSTEACS). Researchers want to reduce the small vessel injury that can occur even when the stent procedure goes well. You may be eligible if: - You are 18 years of age or older - You have had typical heart attack chest pain lasting more than 20 minutes - You have new changes on your ECG or elevated troponin levels showing heart muscle stress - You are scheduled to undergo a coronary stenting procedure (PCI) You may NOT be eligible if: - Your coronary artery is completely blocked - You are having an ST-elevation heart attack - You have a history of blood clotting disorders - You are pregnant or a woman of childbearing age planning pregnancy within 3 months - You have haemodynamic instability (very low blood pressure) or acute heart failure - You have significant liver or kidney impairment - You have pulmonary fibrosis - You have had a hypersensitivity reaction to ambrisentan Talk to your doctor about whether this trial might be right for you.

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.

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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 aft

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)

Prince of Wales Hospital - Randwick

NSW, Australia

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ACTRN12615000709549