Transcatheter Aortic Valve ReplacementPhase 3Co-STARNCT04870424
Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement
A Phase 3 study testing Colchicine in people with Transcatheter Aortic Valve Replacement and Atrial Fibrillation New Onset, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Transcatheter aortic valve implantation (TAVI) is a well-established alternative to surgical aortic valve replacement for the treatment of patients with symptomatic severe aortic stenosis. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transcatheter Aortic Valve Replacement, Atrial Fibrillation New Onset, Pacemaker
- What is being tested?
- Colchicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Sep 2021to 3 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥ 65 years
- Symptomatic severe aortic stenosis defined by an aortic valve area (AVA) ≤1.0 cm2 or an AVA indexed to body surface area <0.6cm2/m2
- Selected to undergo transfemoral TAVI based on heart team decision
Who cannot join
- Life expectancy <1 year irrespective of valvular heart disease
- Kidney disease with a creatinine clearance ≤30 ml/min
- Known severe liver disease
- Known neuromuscular disease
- Clinically significant anaemia with haemoglobin <80g/L
- Known inflammatory bowel disease or chronic diarrhea
Show all 20Show fewer
- Known ongoing bacterial infection
- Known galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- Current treatment with colchicine, steroids or biologicals for any indication
- Concomitant intake of Cyclosporine, Amiodarone, Clarithromycin, Erythromycin, Omeprazole, Verapamil or other strong inhibitors of CYP3A4 or P-Glycoprotein
- Concomitant intake of Carbamazepin, Phenobarbital, Phenytoin, Rifampicin or other strong inductors of CYP3A4 and P-Glycoprotein
- Permanent pacemaker or implantable cardioverter defibrillator
- History of atrial fibrillation
- Absence of sinus rhythm on hospital admission
- Planned non-cardiac surgery within 30 days
- Known intolerance to colchicine
- Inability to provide written informed consent
- Known or suspected non-compliance, drug or alcohol abuse
- Participation in another clinical trial with an active intervention
- Any other planned cardiac intervention performed in the 7 days before TAVI, concomitantly with TAVI or in the 30 days after TAVI except for percutaneous coronary interventions.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Inselspital, Bern University Hospital, Department of Cardiology
Bern, 3010
About this study
Official title: Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement (Co-STAR): a Randomized-controlled Trial
Transcatheter aortic valve implantation (TAVI) is a well-established alternative to surgical aortic valve replacement for the treatment of patients with symptomatic severe aortic stenosis. While peri-procedural complications such as stroke, vascular complications and bleeding have substantially declined with the refinement of transcatheter valves and increasing experience, new-onset atrial fibrillation (NOAF) or atrioventricular conduction disturbances continue to occur in almost half of all patients.
Colchicine is a well-known substance that has been approved for the treatment of acute gout flares and familial Mediterranean fever in many countries. Colchicine has proven safe and effective in the prevention of atrial fibrillation after cardiac surgery. The anti-inflammatory effects of colchicine may mitigate the occurrence of atrioventricular conduction disturbances and thus the need for the implantation of a permanent pacemaker post transcatheter aortic valve implantation.
Read more
The objective of the Co-STAR-Trial is to investigate the efficacy of colchicine for the prevention of new-onset atrial fibrillation and conduction disturbances requiring the implantation of a permanent pacemaker in patients undergoing transcatheter aortic valve implantation.
Co-STAR is an investigator-initiated, randomized, double blind, placebo-controlled trial. A total of 200 patients referred for treatment of symptomatic severe aortic stenosis and selected to undergo TAVI will be randomized in a 1:1 ratio to the treatment with Colchicine or placebo for 30 days post transcatheter aortic valve implantation.
- Conditions
- Transcatheter Aortic Valve Replacement, Atrial Fibrillation New Onset, Pacemaker, Colchicine
- Being tested
- Colchicine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Colchicine in a loading dosage of 1mg single dose per os the day before TAVI and 1mg single dose at the day of procedure. Thereafter, colchicine 0.5mg once daily per os up to post-procedural day 12.
PlaceboDrug
Placebo once daily per os the day before TAVI and once at the day of procedure. Thereafter, once daily per os up to post-procedural day 12.
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | Not described Receives: Drug: Colchicine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of the composite of new onset atrial fibrillation or occurrence of conduction disturbances requiring the implantation of a permanent pacemaker
Assessed based on extended rhythm monitoring performed until 7 days post-discharge as well as clinically or incidentally captured episodes of NOAF captured during routine care thereafter. NOAF is defined as at least one episode of atrial fibrillation with a duration >30s.
Measured: 30 days
Secondary outcomes (8)
Single components of primary composite endpoint
Including predefine sensitivity analysis using the alternative definition of NOAF: At least one episode of atrial fibrillation with a duration >6 min.
Measured: 30 days and 1 year
The incidence of conductance disturbances
New or worsened first-degree atrioventricular (AV) block, second-degree AV block (Mobitz I or Mobitz II), high-grade atrioventricular block, third-degree AV block, right bundle branch block, left bundle branch block, left anterior fascicular block, left posterior fascicular block, intraventricular conduction delay
Measured: 30 days, 1 year
The predictors of conductance disturbances
New or worsened first-degree atrioventricular (AV) block, second-degree AV block (Mobitz I or Mobitz II), high-grade atrioventricular block, third-degree AV block, right bundle branch block, left bundle branch block, left anterior fascicular block, left posterior fascicular block, intraventricular conduction delay
Measured: 30 days, 1 year
The incidence of new arrhythmias resulting in hemodynamic instability or requiring therapy
Defined as electrical/medical cardioversion or initiation of a new medication e.g. oral anticoagulation, rhythm, or rate controlling therapy
Measured: 30 days, 1 year
Inflammatory marker levels
IL-6, IL-8, TNF-alpha, IL-1β, CRP, high-sensitivity CRP
Measured: at day 1
The proportion of patients with at least one prosthetic leaflet with > 50% motion reduction or with at least one prosthetic leaflet with thickening
Based on a study-specific cardiac computed tomography angiography
Measured: 30 days
The proportion of prosthetic leaflets with > 50% motion reduction or leaflet thickening
Based on a study-specific cardiac computed tomography angiography
Measured: 30 days
The incidences of major clinical adverse events
All-cause mortality, stroke, systemic embolism, myocardial infarction, infections, clinical valve thrombosis
Measured: 30 days, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start21 Sep 2021
- Primary completion26 May 2024
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transcatheter Aortic Valve ReplacementStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Pilgrim, Prof., Principal investigator, University of Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870424
- Sponsor's protocol ID
- Co-STAR
- Acronym
- Co-STAR
- Status last verified
- Jun 2025
- First submitted
- 22 Apr 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ryffel C, Lanz J, Guntli N, Samim D, Furholz M, Stortecky S, Tomii D, Heg D, Boscolo Berto M, Peters AA, Reineke D, Reichlin T, Grani C, Windecker S, Pilgrim T. Colchicine in patients with aortic stenosis undergoing transcatheter aortic valve replacement: a double-blind randomized trial. Nat Commun. 2025 Jul 15;16(1):6501. doi: 10.1038/s41467-025-61916-6.
PubMed 40659682
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement (Co-STAR): a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT04870424
- Acronym / sponsor ID
- Co-STAR / Co-STAR
- Conditions
- Transcatheter Aortic Valve Replacement, Atrial Fibrillation New Onset, Pacemaker, Colchicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 26 May 2024 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 3 May 2021 (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.
Transcatheter aortic valve implantation (TAVI) is a well-established alternative to surgical aortic valve replacement for the treatment of patients with symptomatic severe aortic stenosis. While peri-procedural complications such as stroke, vascular complications and bleeding have substantially declined with the refinement of transcatheter valves and increasing experience, new-onset atrial fibrillation (NOAF) or atrioventricular conduction disturbances continue to occur in almost half of all patients.
Colchicine is a well-known substance that has been approved for the treatment of acute gout flares and familial Mediterranean fever in many countries. Colchicine has proven safe and effective in the prevention of atrial fibrillation after cardiac surgery. The anti-inflammatory effects of colchicine may mitigate the occurrence of atrioventricular conduction disturbances and thus the need for the implantation of a permanent pacemaker post transcatheter aortic valve implantation.
The objective of the Co-STAR-Trial is to investigate the efficacy of colchicine for the prevention of new-onset atrial fibrillation and conduction disturbances requiring the implantation of a permanent pacemaker in patients undergoing transcatheter aortic valve implantation.
Co-STAR is an investigator-initiated, randomized, double blind, placebo-controlled trial. A total of 200 patients referred for treatment of symptomatic severe aortic stenosis and selected to undergo TAVI will be randomized in a 1:1 ratio to the treatment with Colchicine or placebo for 30 days post transcatheter aortic valve implantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: Colchicine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥ 65 years
- Symptomatic severe aortic stenosis defined by an aortic valve area (AVA) ≤1.0 cm2 or an AVA indexed to body surface area <0.6cm2/m2
- Selected to undergo transfemoral TAVI based on heart team decision
Key exclusion criteria (20 listed)
- Life expectancy <1 year irrespective of valvular heart disease
- Kidney disease with a creatinine clearance ≤30 ml/min
- Known severe liver disease
- Known neuromuscular disease
- Clinically significant anaemia with haemoglobin <80g/L
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 in a loading dosage of 1mg single dose per os the day before TAVI and 1mg single dose at the day of procedure. Thereafter, colchicine 0.5mg once daily per os up to post-procedural day 12. | Drug | Colchicine |
| PlaceboPlacebo once daily per os the day before TAVI and once at the day of procedure. Thereafter, once daily per os up to post-procedural day 12. | Drug | Placebo |
Primary outcome
Incidence rate of the composite of new onset atrial fibrillation or occurrence of conduction disturbances requiring the implantation of a permanent pacemaker
Time frame: 30 days
Assessed based on extended rhythm monitoring performed until 7 days post-discharge as well as clinically or incidentally captured episodes of NOAF captured during routine care thereafter. NOAF is defined as at least one episode of atrial fibrillation with a duration >30s.
8 secondary outcomes
Single components of primary composite endpoint
Time frame: 30 days and 1 year
The incidence of conductance disturbances
Time frame: 30 days, 1 year
The predictors of conductance disturbances
Time frame: 30 days, 1 year
The incidence of new arrhythmias resulting in hemodynamic instability or requiring therapy
Time frame: 30 days, 1 year
Inflammatory marker levels
Time frame: at day 1
The proportion of patients with at least one prosthetic leaflet with > 50% motion reduction or with at least one prosthetic leaflet with thickening
Time frame: 30 days
The proportion of prosthetic leaflets with > 50% motion reduction or leaflet thickening
Time frame: 30 days
The incidences of major clinical adverse events
Time frame: 30 days, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Derived from this study: PubMed 40659682Ryffel C, Lanz J, Guntli N, Samim D, Furholz M, Stortecky S, Tomii D, Heg D, Boscolo Berto M, Peters AA, Reineke D, Reichlin T, Grani C, Windecker S, Pilgrim T. Colchicine in patients with aortic stenosis undergoing transcatheter aortic valve replacement: a double-blind randomized trial. Nat Commun. 2025 Jul 15;16(1):6501. doi: 10.1038/s41467-025-61916-6.
- 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. This study is not recruiting at the moment.
Thomas Pilgrim, Prof. principal investigator
University of Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine in people with Transcatheter Aortic Valve Replacement and Atrial Fibrillation New Onset, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 20 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: finished, as of the sponsor's last update on 3 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 Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of the composite of new onset atrial fibrillation or occurrence of conduction disturbances requiring the implantation of a permanent pacemaker (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04870424, which also lists 1 linked publication.
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 3 Jun 2026.