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:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT04601467
Eligibility Criteria:
Inclusion Criteria:
* hospitalised for STEMI or non-STEMI, as defined by the 4th universal definition of MI
* underwent coronary angiography during the index hospitalisation showing at least one epicardial coronary artery with ≥50% stenosis and a 2nd epicardial coronary artery with ≥20% stenosis on the coronary angiogram
* Body Mass Index (BMI) ≥18 to ≤40 kg/m2
* White Blood Cell count ≥ 7.0 X 103/uL during admission
Exclusion Criteria:
* Prior coronary artery bypass grafting (CABG)
* CABG planned within 12 months of admission
* Known history of drug or alcohol abuse within 5 years of screening
* History of QT prolongation associated with other medications that required discontinuation of that medication
* Congenital long QT syndrome
* Systolic blood pressure persistently \<90 mm Hg or HR\<40 beats per minute at time of enrolment
* ALT \>2 x ULN, cirrhosis, recent hepatitis, or positive screening test for hepatitis B (hepatitis B surface antigen) or other viral hepatitis
* Uncontrolled Type 1 or Type 2 DM defined as HbA1c \>10% or 74.9 mmol/mol (by IFCC)
* Any planned coronary revascularisation, valve surgery, or cardiac resynchronisation within 7 months after randomisation
* Any concomitant medications known to be associated with Torsades de Pointes or potent inducers of cytochrome P450 3A4 (CYP3A4)
* Planned treatment with zileuton, leukotriene receptor antagonists (e.g., montelukast) during trial
* Participated in another interventional clinical study with an investigational pharmaceutical product during the last 3 months
* Known hypersensitivity to drugs with a similar chemical structure or class of study drugs or any of the excipients of the product
* Known conditions that either increase the risk of performing the CT or make the procedure technically impractical
* No severe asthma attack that require emergency treatment or hospitalisation in the past 6 months
* Had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated), and/or had a confirmed case of COVID-19 within 4 weeks of Screening Visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT04601467
Study Brief:
Protocol Section:
NCT04601467