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Tests treatment safety and results for Statin Adverse Reaction
Official title Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study
ClinicalTrials.gov ID: NCT06874192
What this study is testing
What is Low-dose colchicine at 0.5mg daily?
Low-dose colchicine at 0.5mg daily is an investigational medicine, given as an once-daily, being studied as a potential treatment for statin adverse reaction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- History of statin intolerance (As defined by the NLA 2023 guidelines) Patients who have experienced one or more adverse effects associated with...
- 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.
You likely can't join if
- 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
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.