The LODOCO STINT Pilot Study

Launched by VIRGINIA COMMONWEALTH UNIVERSITY · Mar 7, 2025

Keywords

ClinConnect Summary

The LODOCO STINT Pilot Study is a clinical trial that is looking into how a medication called low dose colchicine can help people who have had bad reactions to statins, which are common cholesterol-lowering drugs. Statins are known for helping reduce the risk of heart problems, but some people can't tolerate them due to side effects. This study aims to see if colchicine, which is an anti-inflammatory medication, can help those individuals stay healthier by reducing inflammation in the body, which is linked to heart issues.

To participate in this study, you need to be between 18 and 80 years old and have a history of experiencing side effects from statins that improve when you lower the dose or stop taking them. You should also be on a stable cholesterol-lowering treatment for at least a month. However, there are certain health conditions that would exclude you from joining, such as severe kidney problems or certain gastrointestinal issues. If you decide to participate, you will receive more information about the study's procedures and what to expect. This trial is currently recruiting participants, so it’s a good time to consider if you might be eligible.

Gender

ALL

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.