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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT03038360
Eligibility Criteria:
Inclusion Criteria:
1. Male and Female patients with non childbearing potential (post-menopausal, ovariectomised or hysterectomised) patients. Menopause is defined as \> 60 years, or between 45 and 60 years being amenorrheic for at least 2 years
2. Age more than 18 years old
3. Acute myocardial infarction with clinical decision to treat with percutaneous coronary intervention
Primary PCI for myocardial infarction:
* ST-elevation myocardial infarction (STEMI) or
* Large non-ST-elevation myocardial infarction (NSTEMI) with hs-Troponin T ≥ 0,1 ng/mL
4. Having signed an Informed Consent to participate in the trial before any study related procedure has been taken.
5. Having signed an Informed Consent for Biobank sampling.
Exclusion Criteria:
1\. Cardiac arrest, ventricular fibrillation, cardiogenic shock, stent thrombosis, previous AMI, angina within 48h before infarction, previous CABG 3. Severe concomitant non-cardiac illnesses 4. Relevant non-coronary cardiac illnesses 5. Planned major surgery 6. Participated in any investigational drug or therapy study with a non-approved medication, within the previous 3 months 7. Being - dependent on the Investigator or the Sponsor (e.g., including but not limited to affiliated employee)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03038360
Study Brief:
Protocol Section:
NCT03038360