Transcatheter Aortic Valve ReplacementLoDoCo-TAVRNCT07411768
Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement
A study testing Colchicine in people with Transcatheter Aortic Valve Replacement and Transcatheter Heart Valve Thrombosis, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This prospective, randomized, open-label study aims to evaluate the efficacy and safety of low-dose colchicine (0.5 mg daily) in reducing transcatheter heart valve (THV) thrombosis in patients after TAVR. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Transcatheter Aortic Valve Replacement, Transcatheter Heart Valve Thrombosis, Anti-inflammatory Therapy
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2026to Jun 2028
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with aortic stenosis aged 60-85 years.
- Successful transfemoral TAVR (per VARC-3 criteria).
- Voluntary participation with signed Informed Consent Form.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100037
About this study
Official title: A Randomized Controlled Trial of Anti-Inflammatory Therapy to Reduce Transcatheter Heart Valve Thrombosis After Transfemoral Transcatheter Aortic Valve Replacement
This prospective, randomized, open-label study aims to evaluate the efficacy and safety of low-dose colchicine (0.5 mg daily) in reducing transcatheter heart valve (THV) thrombosis in patients after TAVR. Participants will be randomly assigned to either receive colchicine plus standard care or standard care alone for 12 months. The primary goal is to compare the rate of valve thrombosis between the two groups using 4D-CT imaging at one year. Additionally, the study will evaluate the treatment's impact on clinical outcomes and its overall safety profile.
Read the detailed description
To ensure balance between the two groups of patients in key prognostic factors, stratified randomization will be used. Stratification factors include: (1) type of implanted prosthetic valve (bulbar valve/self-expanding valve); (2) postoperative baseline antithrombotic regimen (antiplatelet therapy/anticoagulation therapy). Within each stratum, block randomization will be performed using a computer-generated random sequence.
- Conditions
- Transcatheter Aortic Valve Replacement, Transcatheter Heart Valve Thrombosis, Anti-inflammatory Therapy
- Being tested
- Colchicine, Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Colchicine 0.5 mg orally once daily for 12 months
Standard CareOther
Standard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients
| Study group | Role | What they receive |
|---|---|---|
| Colchicine Group | Experimental | 0.5 mg once daily (QD) orally for 12 months, starting after successful TAVR and stabilization before discharge, on top of standard care. Receives: Drug: Colchicine; Other: Standard Care |
| Conventional Treatment | Active comparator | Standard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients, without the use of colchicine. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Transcatheter Heart Valve (THV) Thrombosis
Assessed via 4D-CT imaging to identify leaflet thickening or reduced leaflet motion
Measured: 1 year
Secondary outcomes (3)
Clinical Composite Endpoint: Including stroke, rehospitalization for heart failure, valve dysfunction, and all-cause mortality
Clinical Composite Endpoint: Including stroke, rehospitalization for heart failure, valve dysfunction, and all-cause mortality within 1 year
Measured: 1 month, 1 year
Dynamic Changes in Inflammatory/Coagulation Biomarkers
Dynamic Changes in Inflammatory/Coagulation Biomarkers: Changes in blood markers from baseline to 1 month and 1 year post-TAVR
Measured: 1 month, 1 year
Safety Evaluation: Incidence of adverse drug reactions and laboratory abnormalities
Adverse drug reactions: gastrointestinal symptoms (e.g., nausea, diarrhea, vomiting), myalgia, neuritis, skin rash, gout, hospitalization due to infection, new-onset malignancy, etc.
Laboratory abnormalities: white blood cell count, absolute neutrophil count, liver and renal function, creatine kinase, etc.
Measured: 1 month, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start12 Mar 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ReplacementStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411768
- Sponsor's protocol ID
- 2025-I2M-C&T-B-026
- Acronym
- LoDoCo-TAVR
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Anti-Inflammatory Therapy to Reduce Transcatheter Heart Valve Thrombosis After Transfemoral Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT07411768
- Acronym / sponsor ID
- LoDoCo-TAVR / 2025-I2M-C&T-B-026
- Conditions
- Transcatheter Aortic Valve Replacement, Transcatheter Heart Valve Thrombosis, Anti-inflammatory Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Feb 2026 (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 prospective, randomized, open-label study aims to evaluate the efficacy and safety of low-dose colchicine (0.5 mg daily) in reducing transcatheter heart valve (THV) thrombosis in patients after TAVR. Participants will be randomly assigned to either receive colchicine plus standard care or standard care alone for 12 months. The primary goal is to compare the rate of valve thrombosis between the two groups using 4D-CT imaging at one year. Additionally, the study will evaluate the treatment's impact on clinical outcomes and its overall safety profile.
Detailed description
To ensure balance between the two groups of patients in key prognostic factors, stratified randomization will be used. Stratification factors include: (1) type of implanted prosthetic valve (bulbar valve/self-expanding valve); (2) postoperative baseline antithrombotic regimen (antiplatelet therapy/anticoagulation therapy). Within each stratum, block randomization will be performed using a computer-generated random sequence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine Group | Experimental | Drug: Colchicine, Other: Standard Care0.5 mg once daily (QD) orally for 12 months, starting after successful TAVR and stabilization before discharge, on top of standard care. |
| Conventional Treatment | Active comparator | Other: Standard CareStandard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients, without the use of colchicine. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with aortic stenosis aged 60-85 years.
- Successful transfemoral TAVR (per VARC-3 criteria).
- Voluntary participation with signed Informed Consent Form.
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| ColchicineColchicine 0.5 mg orally once daily for 12 months | Drug | Colchicine Group |
| Standard CareStandard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients | Other | Colchicine Group, Conventional Treatment |
Primary outcome
Incidence of Transcatheter Heart Valve (THV) Thrombosis
Time frame: 1 year
Assessed via 4D-CT imaging to identify leaflet thickening or reduced leaflet motion
3 secondary outcomes
Clinical Composite Endpoint: Including stroke, rehospitalization for heart failure, valve dysfunction, and all-cause mortality
Time frame: 1 month, 1 year
Dynamic Changes in Inflammatory/Coagulation Biomarkers
Time frame: 1 month, 1 year
Safety Evaluation: Incidence of adverse drug reactions and laboratory abnormalities
Time frame: 1 month, 1 year
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 27 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colchicine in people with Transcatheter Aortic Valve Replacement and Transcatheter Heart Valve Thrombosis, run by China National Center for Cardiovascular Diseases at 1 site in China.
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 3 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 27 Oct 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Yunqing Ye, MD, PhD (8613699282532, judia8510@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Transcatheter Heart Valve (THV) Thrombosis (time frame: 1 year). 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 27 Oct 2026.