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 @ 3:21 PM
Ignite Modification Date:
2025-12-24 @ 3:21 PM
NCT ID:
NCT06941792
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent must be obtained prior to participation in the study
2. Documented diagnosis of CHD prior to screening, including acute coronary syndrome (ACS) and chronic coronary syndrome (CCS)
3. Aged ≥18 years at randomization
4. Despite maximally tolerated statin therapy for ≥4weeks stable using prior to screening, LDL-C result at screening not at goal (≥1.8 mmol/L).
The maximum tolerated dose of statins also includes patients with statin intolerance or contraindication.
Exclusion Criteria:
1. Received inclisiran during the 2 years prior to the screening.
2. Received proprotein convertase subtilisin-kexin type 9 (PCSK9) mabs during the 3 months prior to screening.
3. Participating in an interventional trial at enrollment
4. Having severe liver disorder (Child-Pugh class C)
5. Any other condition that may put the participant at significant risk if the participant participate in the current study, according to investigator's (or delegate's) judgment.
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT06941792
Study Brief:
Protocol Section:
NCT06941792