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 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT06874192
Eligibility Criteria:
Inclusion Criteria:
* History of statin intolerance (As defined by the NLA 2023 guidelines) Patients who have experienced one or more adverse effects associated with statin therapy, which resolves or improves with dose continuation or reduction
* Stable dose of lipid-lowering regimen (statin or non-statin) for at least one month
* Patients able to provide informed consent.
* Aged 18 to 80 will be enrolled in the study.
Exclusion Criteria:
* Known hypersensitivity to colchicine, current use of colchicine or other anti-inflammatory medications.
* Renal impairment (eGFR \<45 mL/min/1.73 m2)
* Transaminitis (ALT or AST \>3 times upper limit of normal)
* Cirrhosis
* Severe Heart Failure
* Active cancer or currently on chemotherapy
* Irritable Bowel Syndrome, Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis) or other diarrheal related GI pathologies
* Active infection
* Autoimmune or inflammatory condition
* Pregnancy or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06874192
Study Brief:
Protocol Section:
NCT06874192