Low-dose Colchicine after TAVR to help prevent valve clots

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, open-label trial enrolling patients who have undergone transfemoral TAVR. Participants are assigned to colchicine 0.5 mg daily plus standard care or standard care alone for one year, with 4D-CT at one year to assess valve thrombosis. Randomization uses stratification by valve type and baseline antithrombotic therapy, followed by block randomization within strata to balance key prognostic factors. The study also evaluates clinical outcomes and safety of the colchicine regimen in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with aortic stenosis aged 60-85 years.
* Successful transfemoral TAVR (per VARC-3 criteria).
* Voluntary participation with signed Informed Consent Form.

Exclusion Criteria:

* Known hypersensitivity, allergy, or documented intolerance to colchicine.
* Hematologic abnormalities defined as hemoglobin \<80 g/L or white blood cell count \<4.0 × 10⁹/L at screening.
* Severe renal impairment defined as creatinine clearance \<30 mL/min (calculated by the Cockcroft-Gault formula) or serum creatinine \>2 × upper limit of normal (ULN).
* Significant hepatic disease, including liver cirrhosis, chronic active hepatitis, hepatic injury (alanine aminotransferase \>3 × ULN or total bilirubin \>2 × ULN), or cholestasis.
* Known history of bone marrow suppression.
* Concomitant use of strong CYP3A4 or P-glycoprotein (P-gp) inhibitors, including but not limited to cyclosporine, amiodarone, clarithromycin, erythromycin, omeprazole, or verapamil.
* Concomitant use of strong CYP3A4 or P-glycoprotein (P-gp) inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, or rifampin.
* Known neuromuscular disorders or creatine kinase (CK) \>3 × ULN at screening.
* Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea.
* Active malignancy or history of cancer.
* Current use of systemic corticosteroids (oral or intravenous) or systemic immunosuppressive agents (topical or inhaled corticosteroids permitted).
* Acute inflammatory condition or active viral infection at the time of enrollment.
* Known galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
* Estimated life expectancy \<1 year as determined by the investigator.

Where it's running

• Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, China Recruiting

Study contacts

• Study coordinator: Yunqing Ye, MD, PhD
• Email: judia8510@163.com
• Phone: 8613699282532

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.