Heart attack survivors with gene variant may benefit from colchicine
NCT ID NCT07362966
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This pilot study tests whether the drug colchicine can reduce artery plaque in 120 heart attack survivors who have a specific genetic change (TET2-CHIP). Participants take colchicine or standard care for 12 months. The goal is to see if this genetic marker can guide personalized treatment for heart disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- colchicine
- What this could lead to
- If successful, this could show that colchicine works better for people with a specific genetic marker, leading to more personalized heart disease treatment.
- What could go wrong
- This is a small pilot study, so results may not be conclusive. Colchicine can cause side effects like stomach upset, and it's not yet proven to reduce heart attacks in this group.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2026
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 40-85 years; 2. Patients with recent hospitalization for documented ACS (the index event occurring 30-90 days before randomization) and meeting all of the following: 1. During the index hospitalization, patients underwent either PCI or diagnostic coronary angiography alone, 2. At least one non-culprit coronary lesion with 30%-70% diameter stenosis by visual estimation on coronary angiography, 3. Clinically stable throughout the screening period, 4. Receiving standard of care therapy for ACS in accordance with national guidelines, 5. Peripheral blood DNA available for targeted sequencing, with results demonstrating either TET2-CHIP or no CHIP-associated variants; 3. Written informed consent. Exclusion Criteria: 1. Prior coronary artery bypass grafting (CABG) before documented ACS; 2. Other clinically significant cardiovascular diseases, including moderate-to-severe valvular heart disease (moderate or severe), heart failure (NYHA class III-IV), or atrial fibrillation; 3. Non-culprit coronary anatomy (e.g., marked tortuosity, bifurcation lesions, or small vessels \<1.5 mm in diameter) deemed to preclude plaque assessment by CCTA; 4. Planned PCI or CABG; 5. Abnormal liver function (ALT \>3 times the upper limit of normal range) at randomization; 6. Abnormal renal function (serum creatinine \>1.5 times the upper limit of normal range or estimated eGFR \<45 mL/min/1.73 m²) at randomization; 7. Hematologic abnormalities: anemia (hemoglobin \<100g/L), thrombocytopenia (platelet count \<100×109/L) or leukopenia (white blood cell \<3×109/L) at randomization; 8. Inflammatory bowel disease (Crohn's or ulcerative colitis) or active diarrhea; 9. Symptomatic peripheral neuropathy, pre-existing progressive neuromuscular disease or creatine kinase (CK) level \> 3 times the upper limit of normal range as measured within the past 30 days and determined to be non-transient through repeat testing; 10. Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception; 11. Any contraindication, known allergy or intolerance to colchicine; 12. Colchicine use within 30 days prior to randomization, or planned colchicine therapy for other indications; 13. Current or planned use of any of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics; 14. Existing or planned treatment with other anti-inflammatory or immunosuppressive drugs; 15. History of malignancy (hematologic or solid-tumor); 16. History of transplantation (hematopoietic stem cell or solid-organ); 17. Significant radiation exposure (≥40 mSv) within the past 12 months; 18. Known hypersensitivity to iodinated contrast media or uncontrolled active hyperthyroidism; 19. Current enrollment in another clinical trial; 20. A predicted life expectancy \< 1 year; 21. Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute coronary syndrome are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
General Hospital of Northern Theater Command
RECRUITINGShenyang, Liaoning, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Tailoring cardiac rehab to each heart: can personalized training speed recovery?
- Can a 20-Minute playlist calm a heart attack Patient's nerves?
- Can a common gout pill shield hearts after stents?
- A simple ultrasound test may sharpen heart attack risk predictions
- Could a personal playlist calm nerves during heart surgery?
- Can hidden blood mutations ignite heart disease?