ColchicinePhase 4NCT07287345
Colchicine's Effect on Inflammatory Markers
A Phase 4 study testing Colchicine (Colcrys®) in people with Colchicine and Inflammation in Cardiac Surgery, run by Ayesha Ather at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colchicine, Inflammation in Cardiac Surgery, Post Operative Atrial Fibrillation
- What is being tested?
- Colchicine (Colcrys®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2026to 30 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Coronary artery bypass graft (CABG) planned procedure
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucy
Lexington, Kentucky, 40536
Ayesha Ather, 4067214036, ayesha.ather@uky.edu
About this study
Official title: Adjunctive Colchicine's Effect on Inflammatory Markers and Corresponding New-Onset Atrial Fibrillation Rates Post Coronary Artery Bypass Graft Procedure: A Pilot Study
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. Participants will be randomly placed into one of two groups: one group will receive colchicine along with usual care, and the other will receive a placebo (a look-alike capsule with no medicine) along with usual care. Everyone will take a study capsule, and neither the patients nor the study team will know which capsule is being given. Everyone in the study will take study capsule, and neither the patients nor the study team will know who is receiving colchicine or placebo. Blood samples and health information will be collected before surgery; at 24, 48, 72, and 96 hours after surgery; and again at 10 days after surgery or at hospital discharge, whichever comes first. The investigators will look at inflammation marker levels, whether atrial fibrillation happens, and any side effects. This small study will help to generate effect size estimates and safety data that will help plan a larger study in the future.
- Conditions
- Colchicine, Inflammation in Cardiac Surgery, Post Operative Atrial Fibrillation, Inflammatory Markers, Colchicine Adverse Reaction
- Being tested
- Colchicine (Colcrys®), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine (Colcrys®)Drug
Colchicine dosing is based on actual body weight and renal function (creatinine clearance). Subjects will initiate study medication (placebo or active drug) 5 days prior to surgery and continue therapy for 10 days postoperatively or until hospital discharge, whichever occurs first.
For patients weighing ≥70 kg:
If CrCl >30 mL/min: Colchicine 0.6 mg twice daily
If CrCl <30 mL/min: Colchicine 0.3 mg once daily
For patients weighing <70 kg:
If CrCl >30 mL/min: Colchicine 0.6 mg once daily
If CrCl <30 mL/min: Colchicine 0.3 mg every other day
PlaceboDrug
Placebo dosing is based on actual body weight and renal function (creatinine clearance). Subjects will initiate study medication (placebo or active drug) 5 days prior to surgery and continue therapy for 10 days postoperatively or until hospital discharge, whichever occurs first.
For patients weighing ≥70 kg:
If CrCl >30 mL/min: Placebo 0.6 mg twice daily
If CrCl <30 mL/min: Placebo 0.3 mg once daily
For patients weighing <70 kg:
If CrCl >30 mL/min: Placebo 0.6 mg once daily
If CrCl <30 mL/min: Placebo 0.3 mg every other day
| Study group | Role | What they receive |
|---|---|---|
| Standard of care and placebo | Placebo comparator | placebo capsule Receives: Drug: Placebo |
| Standard of care and colchicine | Experimental | colchicine capsule Receives: Drug: Colchicine (Colcrys®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inflammatory markers
markers of inflammation (IL-6, CRP, IL-18, IL-1β, IL-8, and TNF-α) will be measured at predefined time points. Blood samples will be obtained as part of routine clinical care and analyzed using commercially available ELISA assays.
Measured: Baseline (pre-surgery), 24, 48, 72, 96 hours post-surgery and 10 days postoperatively or at discharge, whichever occurs first.
Rate of post-operative atrial fibrillation (POAF)
Postoperative atrial fibrillation (POAF) incidence will be assessed through daily chart review.
Measured: Through discharge (up to 15 days)
Secondary outcomes (5)
Number of participants discontinuing treatment
treatment discontinuation rates due to adverse events will be measured
Measured: Through discharge (up to 15 days)
Change in Liver Function
Assessed as the impact on clinical biomarkers, i.e., ALT, AST in units per liter.
Measured: Baseline and Post operatively (approximately 24 hours)
Change in creatinine level
Assessed as the impact on clinical biomarkers, i.e., creatinine level in mg/dl
Measured: Baseline through discharge (up to 15 days)
Creatine kinase level
Assessed as the impact on clinical biomarkers, creatine kinase (i.e., CK level) in units per liter
Measured: Through discharge (up to 15 days)
Complete blood count (CBC).
Assessed as the impact on clinical biomarker complete blood count (CBC).
Measured: Through discharge (up to 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start16 Jan 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColchicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayesha Ather
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayesha Ather, University of Kentucky
- Investigators
- Sibu Saha, MD, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287345
- Sponsor's protocol ID
- 102331
- Status last verified
- Jun 2026
- First submitted
- 1 Dec 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Colchicine's Effect on Inflammatory Markers and Corresponding New-Onset Atrial Fibrillation Rates Post Coronary Artery Bypass Graft Procedure: A Pilot Study
- ClinicalTrials.gov ID
- NCT07287345
- Acronym / sponsor ID
- 102331
- Conditions
- Colchicine, Inflammation in Cardiac Surgery, Post Operative Atrial Fibrillation, Inflammatory Markers, Colchicine Adverse Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ayesha AtherUniversity, hospital or other
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Participants will be randomly placed into one of two groups: one group will receive colchicine along with usual care, and the other will receive a placebo (a look-alike capsule with no medicine) along with usual care. Everyone will take a study capsule, and neither the patients nor the study team will know which capsule is being given. Everyone in the study will take study capsule, and neither the patients nor the study team will know who is receiving colchicine or placebo. Blood samples and health information will be collected before surgery; at 24, 48, 72, and 96 hours after surgery; and again at 10 days after surgery or at hospital discharge, whichever comes first. The investigators will look at inflammation marker levels, whether atrial fibrillation happens, and any side effects. This small study will help to generate effect size estimates and safety data that will help plan a larger study in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care and placebo | Placebo comparator | Drug: Placeboplacebo capsule |
| Standard of care and colchicine | Experimental | Drug: Colchicine (Colcrys®)colchicine capsule |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years and older
- Coronary artery bypass graft (CABG) planned procedure
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine (Colcrys®)Colchicine dosing is based on actual body weight and renal function (creatinine clearance). Subjects will initiate study medication (placebo or active drug) 5 days prior to surgery and continue therapy for 10 days postoperatively or until hospital discharge, whichever occurs first. For patients weighing ≥70 kg: If CrCl >30 mL/min: Colchicine 0.6 mg twice daily If CrCl <30 mL/min: Colchicine 0.3 mg once daily For patients weighing <70 kg: If CrCl >30 mL/min: Colchicine 0.6 mg once daily If CrCl <30 mL/min: Colchicine 0.3 mg every other day | Drug | Standard of care and colchicine |
| PlaceboPlacebo dosing is based on actual body weight and renal function (creatinine clearance). Subjects will initiate study medication (placebo or active drug) 5 days prior to surgery and continue therapy for 10 days postoperatively or until hospital discharge, whichever occurs first. For patients weighing ≥70 kg: If CrCl >30 mL/min: Placebo 0.6 mg twice daily If CrCl <30 mL/min: Placebo 0.3 mg once daily For patients weighing <70 kg: If CrCl >30 mL/min: Placebo 0.6 mg once daily If CrCl <30 mL/min: Placebo 0.3 mg every other day | Drug | Standard of care and placebo |
Primary outcome
Change in Inflammatory markers
Time frame: Baseline (pre-surgery), 24, 48, 72, 96 hours post-surgery and 10 days postoperatively or at discharge, whichever occurs first.
markers of inflammation (IL-6, CRP, IL-18, IL-1β, IL-8, and TNF-α) will be measured at predefined time points. Blood samples will be obtained as part of routine clinical care and analyzed using commercially available ELISA assays.
Rate of post-operative atrial fibrillation (POAF)
Time frame: Through discharge (up to 15 days)
Postoperative atrial fibrillation (POAF) incidence will be assessed through daily chart review.
5 secondary outcomes
Number of participants discontinuing treatment
Time frame: Through discharge (up to 15 days)
Change in Liver Function
Time frame: Baseline and Post operatively (approximately 24 hours)
Change in creatinine level
Time frame: Baseline through discharge (up to 15 days)
Creatine kinase level
Time frame: Through discharge (up to 15 days)
Complete blood count (CBC).
Time frame: Through discharge (up to 15 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sibu Saha, MD study director
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine (Colcrys®) in people with Colchicine and Inflammation in Cardiac Surgery, run by Ayesha Ather at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayesha Ather (8592184157, ayesha.ather@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inflammatory markers (time frame: Baseline (pre-surgery), 24, 48, 72, 96 hours post-surgery and 10 days postoperatively or at discharge, whichever occurs first.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.