Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-24 @ 7:37 PM
NCT ID:
NCT04252703
Eligibility Criteria:
Inclusion Criteria:
* Age ≥80 years
* Non-ST-elevation acute coronary syndromes, defined as per guidelines:
* Ischaemic chest pain or equivalent AND either
* Electrocardiography with persistent or transient ST-depression and/or T-wave inversion OR
* Biomarker positive for myocardial necrosis
* Multi-vessel coronary artery disease, defined as the presence of an angiographic \>90% diameter or FFR-(\<0.81) or iFR-(\<0.90) positive stenoses(29) in a non-culprit vessel of reference diameter ≥2.5mm.
Exclusion Criteria:
* Inability to give written informed consent
* Resuscitation from cardiac arrest
* Life expectancy \<12 months
* Cardiogenic shock
* Ventricular arrhythmias refractory to treatment at the time of randomization
* Coronary artery disease not amenable to PCI
* Heart Team decision for coronary bypass surgery
* Type 2 myocardial infarction(30) or alternative diagnoses such as tako-tsubo cardiomyopathy, as defined by the operator in light of the clinical picture at presentation
* Estimated glomerular filtration rate (eGFR) \<20mL/min/m2 (by Cockcroft-Gault formula)
* Documented anaphylaxis induced by iodinated contrast media
* Documented allergies to either aspirin, clopidogrel, ticagrelor or oral anticoagulants
* Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, the following:
* Active internal bleeding
* Bleeding diastheses precluding treatment with dual antiplatelet therapy and/or oral anticoagulation
* Platelet count \<90,000/μL at screening
* Previous intracranial haemorrhage
* Clinically significant gastrointestinal bleeding within 12 months before randomization
* Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis), or liver function test (LFT) abnormalities at screening (confirmed with repeat testing): alanine transaminase (ALT) \>5 times the upper limit of normal or ALT \>3 times the upper limit of normal plus total bilirubin \>2 times the upper limit of normal
* Major surgery, biopsy of a parenchymal organ, or serious trauma (including head trauma) within the past 30 days
* Any active non-cutaneous malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
80 Years
Study:
NCT04252703
Study Brief:
Protocol Section:
NCT04252703