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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT03317002
Eligibility Criteria:
Inclusion Criteria:
* Males and females of non-childbearing potential
* Age ≥18 to ≤75
* Body Mass Index (BMI) ≥18 to ≤35 kg/m2
* CAD patients, here defined as:
ACS 7-28 days prior to study randomization (ACS defined as STEMI, non STEMI event documented by Electrocardiogram (ECG), cardiac enzymes \[troponin\] and angiogram) Provision of signed and dated, written informed consent prior to any study specific procedures
Exclusion Criteria:
* Uncontrolled Type 1 or Type 2 diabetes defined as haemoglobin A1c (HbA1c) Diabetes
* Control and Complications Trial (DCCT)\> 9% or International Federation of Clinical Chemistry (IFCC) \>74.9 mmol/mol
* Patients with atrial fibrillation (chronic or current) or history of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia or sick sinus syndrome or Atrioventricular blockage degree 2-3
* Prior coronary artery by-pass graft (Coronary artery bypass grafting) to Left Anterior Descending artery (LAD)
* Left ventricle ejection fraction \< 30%
* Unacceptable level of angina despite maximal medical therapy or unstable angina at entry
* Canadian Cardiovascular Society (CCS) ≥ 3 (Visit 1 or Visit 2)
* Stroke within the previous 6 months from ACS or ongoing treatment with Persantin or Asasantin
* Chronic use of anticoagulants on therapeutic dose (not including thrombosis prophylaxis) during the study
* Planned additional cardiac intervention (e.g., Percutaneous coronary intervention (PCI), Coronary artery bypass grafting (CABG) within next 6 months
* New York Heart Association (NYHA) class III-IV heart failure or decompensated heart failure at discharge or hospitalization for exacerbation of chronic heart failure within the previous 3 months from ACS
* Previously known severe renal disease (Chronic Kidney Disease (CKD) stage 4 or 5) or previously known creatinine clearance calculated by Cockcroft Gault equation \<30 ml/min\*m2
* Known allergy to adenosine and mannitol, or experience of previous adverse effects of adenosine stress testing.
* Participation in another interventional clinical study with an investigational pharmaceutical product during the last 3 months also including drug eluting stents.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03317002
Study Brief:
Protocol Section:
NCT03317002