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New treatment option for Colchicine
Official title Colchicine's Effect on Inflammatory Markers
ClinicalTrials.gov ID: NCT07287345
What this study is testing
What is Colchicine (Colcrys®)?
Colchicine (Colcrys®) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for colchicine.
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
- This study wants to see if the medicine colchicine can help lower inflammation and reduce the chance of developing an irregular heartbeat (atrial fibrillation) after heart bypass surgery. Adults having coronary artery bypass surgery (CABG) can join.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 99
You may be able to join if
- Age 18 years and older
- Coronary artery bypass graft (CABG) planned procedure
You likely can't join if
- History of atrial fibrillation
- Off-pump CABG procedure
- Current treatment with colchicine for any cause
- Hypersensitivity to colchicine (as indicated by rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever)
- Emergency cardiac surgery
- Extracorporeal Membrane Oxygenation (ECMO) pre- or post-cardiac surgery
See the full eligibility criteria
- Age 18 years and older
- Coronary artery bypass graft (CABG) planned procedure
- History of atrial fibrillation
- Off-pump CABG procedure
- Current treatment with colchicine for any cause
- Hypersensitivity to colchicine (as indicated by rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever)
- Emergency cardiac surgery
- Extracorporeal Membrane Oxygenation (ECMO) pre- or post-cardiac surgery
- Heart transplant patients
- Left ventricular assist device (LVAD) patients
- Serum creatinine \>2.0 mg/dL
- Preoperative elevated CK or known myopathy
- Severe liver disease or elevation of serum transaminases (\>1.5 times the upper limit of 40 units/liter)
- Chronic intestinal disease or blood dyscrasia
- Unable to speak English
- Pregnancy or lactation in women
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, 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 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, 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.