Low-Dose Colchicine for Statin Adverse Reaction Syndrome

Overseen By Joshua West

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Virginia Commonwealth University

Must be taking: Lipid-lowering drugs

Must not be taking: Colchicine, Anti-inflammatories

Disqualifiers: Renal impairment, Cirrhosis, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Anurag Mehta

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for individuals who have experienced adverse reactions to statins, which are medications used to lower cholesterol and reduce the risk of heart problems. Participants should be at risk for cardiovascular issues due to untreated high cholesterol.

Inclusion Criteria

Patients able to provide informed consent

I am intolerant to statins as per the 2023 NLA guidelines.

I have been on a stable cholesterol medication for at least one month.

Exclusion Criteria

I have severe heart failure.

I currently have an infection.

Pregnancy or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low-dose colchicine or placebo for 4 weeks

4 weeks

Scheduled study visits with investigator-administered questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Low-dose colchicine

Trial Overview The study is testing low-dose colchicine (0.5mg daily), an anti-inflammatory medication, against a placebo to see if it can reduce the risk of future cardiac events in people who cannot tolerate statins.

Participant Groups

Group I: Matching placebo and then low dose colchicine Experimental Treatment 2 Interventions

Participants in this arm will be randomized to receive placebo for 4 weeks and then low-dose colchicine (0.5 mg once daily)

Group II: Low dose colchicine and then matching placebo Experimental Treatment 2 Interventions

Participants in this arm will be randomized to receive low-dose colchicine (0.5 mg once daily) and then placebo for 4 weeks

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+