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
- Conditions
- Peri-procedural myocardial injury/infarctionNon-ST elevation acute coronary syndrome (NSTEACS)Cardiovascular - Coronary heart disease
- Registration Number
- ACTRN12615000709549
- Lead Sponsor
- Prince of Wales Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 52
1) Age > 18 years
2) Typical ischaemic chest pain lasting > 20 minutes
3) Either
*Electrocardiographic changes: new ST segment depression of > 0.1mV in >2 contiguous leads; or
*New transient T wave inversion of > 0.2mV in > 2 contiguous leads or
*Troponin T > 100 ng/L; or a 30% rise in a 6-hour troponin when the initial troponin T is 14 – 100 ng/L.
1) complete occlusion of the culprit artery
2) ST-elevation myocardial infarction
3) prior history of a thrombotic disorder
4) pregnant women or women of child bearing potential who are planning to become pregnant within the next 3 months
5) haemodynamic instability
6) acute heart failure during the index admission
7) significant hepatic impairment (history or cirrhosis or abnormal serum ALT or AST 3-fold greater than the upper limit of normal)
8) Patients with idiopathic pulmonary fibrosis (IPF) with or without secondary pulmonary hypertension.
9) Patients who exhibit or may exhibit hypersensitivity to ambrisentan or to any of the excipients
10) significant renal impairment
11) failure to advance either the guide-wire or the angioplasty balloon beyond the stenosis
12) proximal type” procedural complication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method