RECRUITING

The LODOCO STINT Pilot Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Statins are a class of cholesterol lowering medications that contribute to reducing a person's risk of experiencing a cardiovascular event like heart attack. Along with the ability to lower cholesterol, statins also possess anti-inflammatory properties which contribute to their cardioprotective effects. Some people experience side effects while taking statins and are unable to continue treatment with them,which can then increase a person's risk of having cardiovascular issues due to untreated high cholesterol levels. Prior studies have shown that inflammation in the body may lead to an increased risk of a future cardiovascular events. Low dose colchicine (LODOCO), an anti-inflammatory agent, has been shown to reduce cardiovascular events by inhibiting inflammation, a major cause of cardiovascular disease. The United States Food and Drug Administration (FDA) has approved LODOCO to reduce the risk of a future cardiac events for those who have existing heart disease or possess multiple risk factors for heart disease.

Official Title

Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study

Quick Facts

Study Start:2025-04
Study Completion:2026-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06874192

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Stable dose of lipid-lowering regimen (statin or non-statin) for at least one month
  3. * Patients able to provide informed consent.
  4. * Aged 18 to 80 will be enrolled in the study.
  1. * Known hypersensitivity to colchicine, current use of colchicine or other anti-inflammatory medications.
  2. * Renal impairment (eGFR \<45 mL/min/1.73 m2)
  3. * Transaminitis (ALT or AST \>3 times upper limit of normal)
  4. * Cirrhosis
  5. * Severe Heart Failure
  6. * Active cancer or currently on chemotherapy
  7. * Irritable Bowel Syndrome, Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis) or other diarrheal related GI pathologies
  8. * Active infection
  9. * Autoimmune or inflammatory condition
  10. * Pregnancy or breastfeeding.

Contacts and Locations

Study Contact

Emily Federmann
CONTACT
804-828-3299
Emily.Federmann@vcuhealth.org
Joshua West
CONTACT
804.628.3981
Joshua.West@vcuhealth.org

Principal Investigator

Anurag Mehta
PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University

Study Locations (Sites)

Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Anurag Mehta, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04
Study Completion Date2026-04-01

Study Record Updates

Study Start Date2025-04
Study Completion Date2026-04-01

Terms related to this study

Keywords Provided by Researchers

  • statin intolerance

Additional Relevant MeSH Terms

  • Statin Adverse Reaction