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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-12

Study Completion Date

2026-04-01

Brief Summary

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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.

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Detailed Description

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This study will test the effects of LODOCO in those who have previously been identified as statin intolerant, meaning they are unable to continue taking statins because of side effects. The primary objective of this study is to evaluate the safety and efficacy of low-dose colchicine (LODOCO) in subjects with statin intolerance. Safety will be assessed by monitoring the incidence of adverse events from baseline to four weeks. Efficacy will be determined by measuring the change in high-sensitivity C-reactive protein (hs-CRP) levels from baseline to four weeks..

Conditions

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Statin Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Single-center, double-blind, placebo-controlled, randomized cross-over pilot study

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Participants will be randomized in a 1:1 ratio to receive either low-dose colchicine (0.5 mg once daily) or matching placebo for 4 weeks.

Study Groups

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Low dose colchicine and then matching placebo

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

Group Type EXPERIMENTAL

Low-dose colchicine at 0.5mg daily

Intervention Type DRUG

LODOCO is low-dose colchicine at 0.5mg daily, ii is an FDA approved anti-inflammatory drug, to prevent cardiovascular events in patients with coronary artery disease. LODOCO works by inhibiting microtubule formation and reducing the activity of neutrophils, which play a key role in inflammation.

Placebo

Intervention Type OTHER

Matching placebo

Matching placebo and then low dose colchicine

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

Group Type EXPERIMENTAL

Low-dose colchicine at 0.5mg daily

Intervention Type DRUG

LODOCO is low-dose colchicine at 0.5mg daily, ii is an FDA approved anti-inflammatory drug, to prevent cardiovascular events in patients with coronary artery disease. LODOCO works by inhibiting microtubule formation and reducing the activity of neutrophils, which play a key role in inflammation.

Placebo

Intervention Type OTHER

Matching placebo

Interventions

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Low-dose colchicine at 0.5mg daily

LODOCO is low-dose colchicine at 0.5mg daily, ii is an FDA approved anti-inflammatory drug, to prevent cardiovascular events in patients with coronary artery disease. LODOCO works by inhibiting microtubule formation and reducing the activity of neutrophils, which play a key role in inflammation.

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No