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

StatusCompleted
PhasePhase 1
Started
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Record History

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  1. Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of Aug 30, 2026 to May 6, 2026
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
  2. Primary and study completion pushed from May 30, 2026 to Aug 30, 2026v4
  3. Primary completion date: Dec 30, 2025 to May 30, 2026
    • Study completion date: Apr 1, 2026 to May 30, 2026
    v3
  4. Start date changed from estimate of Apr 2025 to Mar 12, 2025
    • Study title expanded, about 12 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06874192
Lead Sponsor Virginia Commonwealth University
Conditions
(from sponsor)		 Statin Adverse Reaction
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov