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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if low-dose colchicine, a drug known for reducing inflammation, can assist individuals who cannot tolerate statins due to side effects. Statins lower cholesterol and reduce heart attack risk, but some experience side effects that lead them to discontinue use, increasing their heart risk. The trial will compare colchicine to a placebo (a harmless pill with no active ingredients) to assess its effectiveness in managing cholesterol-related inflammation without statin side effects. It seeks participants who have experienced statin side effects but have maintained stable cholesterol levels with other treatments for at least a month. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial requires that you have been on a stable dose of your current cholesterol-lowering medication for at least one month, so you won't need to stop taking it. However, you cannot participate if you are currently using colchicine or other anti-inflammatory medications.

Is there any evidence suggesting that low-dose colchicine is likely to be safe for humans?

Research has shown that low-dose colchicine is generally safe. Studies have found it can reduce the risk of major heart problems by about 31% in individuals with stable heart disease, indicating good tolerance in these cases. Some trials examined serious side effects, such as hospital stays due to stomach issues or infections, but these were rare. Additionally, the FDA has approved low-dose colchicine for those with heart disease or risk factors, supporting its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Colchicine is unique because it offers a potential new approach for managing Statin Adverse Reaction Syndrome, which usually involves stopping or reducing statin dosage, or switching to another lipid-lowering treatment. Unlike standard treatments that mainly focus on altering statin therapy, colchicine aims to alleviate symptoms by reducing inflammation, thanks to its anti-inflammatory properties. Researchers are excited about colchicine because it targets the inflammatory response that might contribute to the adverse reactions, potentially allowing patients to continue benefiting from their statin medications without discomfort.

What evidence suggests that low-dose colchicine might be an effective treatment for statin adverse reaction syndrome?

Studies have shown that a low dose of colchicine can significantly lower the risk of major heart problems. For individuals with stable coronary artery disease, colchicine reduced these risks by 23% to 31%. It also decreases the chances of heart attacks and strokes. Colchicine reduces inflammation, which plays a significant role in heart disease. The FDA has approved low-dose colchicine for reducing heart risks in people with heart disease or those at high risk. This trial will evaluate low-dose colchicine as a promising option for those who cannot take statins due to side effects. Participants will receive either low-dose colchicine followed by placebo or placebo followed by low-dose colchicine. ^{1 2 3 4 5}

Who Is on the Research Team?

Anurag Mehta

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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

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

Patients able to provide informed consent

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

Exclusion Criteria

I have severe heart failure.

Pregnancy or breastfeeding

I am currently undergoing chemotherapy or have active cancer.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. trialx.com trialx.com/clinical-trials/listings/298315/safety-and-efficacy-of-low-dose-colchicine-in-patients-with-statin-intolerance-the-lodoco-stint-pilot-study/

Safety and Efficacy of LOw DOse COlchicine in Patients ... The primary objective of this study is to evaluate the safety and efficacy of low-dose colchicine (LODOCO) in subjects with statin intolerance.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11872516/

Potential Impact of Colchicine on Atherosclerotic ... Central Illustration. ... Colchicine lowers the risk of major adverse cardiovascular events in stable coronary artery disease by 23% to 31% beyond ...

3. jacc.org jacc.org/doi/10.1016/j.jacc.2023.05.055

Low-Dose Colchicine for Secondary Prevention of ... Low-dose colchicine (0.5 mg/d orally) has been shown to safely lower major adverse cardiovascular events by 31% among those with stable atherosclerosis and by ...

4. ahajournals.org ahajournals.org/doi/10.1161/ATVBAHA.124.319851

Colchicine's Role in Cardiovascular Disease Management Colchicine—an anti-inflammatory alkaloid—has assumed an important role in the management of cardiovascular inflammation ≈3500 years after ...

5. academic.oup.com academic.oup.com/eurheartj/article/46/26/2552/8123897

Long-term trials of colchicine for secondary prevention of ... This updated meta-analysis of RCTs demonstrated a substantial reduction in MACE, MI, ischaemic stroke, and recurrent coronary revascularization with colchicine ...