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Can a cheap arthritis pill prevent deadly clots after heart valve replacement?

NCT ID NCT07411768

Disease control Sponsor: China National Center for Cardiovascular Diseases Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a daily low-dose anti-inflammatory drug (colchicine) can prevent blood clots from forming on replacement heart valves after a minimally invasive valve procedure (TAVR). About 116 people who have had TAVR will either receive colchicine plus standard care or standard care alone for one year. The main goal is to see if colchicine reduces valve clots detected by special CT scans.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 116 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anti-inflammatory therapy Transcatheter aortic valve replacement Transcatheter heart valve thrombosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

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

    Beijing, 100037, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.