NCT04870424CompletedPhase 3
Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement
Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement (Co-STAR): a Randomized-controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 22 Apr 2021
- Start date
- 21 Sept 2021
- Primary completion date
- 26 May 2024
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- Atrial fibrillation
- NCT number
- NCT04870424
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 120
- From 21 Sept 2021 to the primary completion date, 26 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Known or suspected non-compliance, drug or alcohol abuse
- 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.
Other illness
- Life expectancy \<1 year irrespective of valvular heart disease
- Known severe liver disease
- Known neuromuscular disease
- Known inflammatory bowel disease or chronic diarrhea
- Known ongoing bacterial infection
- History of atrial fibrillation
- Planned non-cardiac surgery within 30 days
Lab values
- Kidney disease with a creatinine clearance ≤30 ml/min
- Clinically significant anaemia with haemoglobin \<80g/L
- Known galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Other
- Permanent pacemaker or implantable cardioverter defibrillator
- Absence of sinus rhythm on hospital admission
- Known intolerance to colchicine
- Inability to provide written informed consent
- Participation in another clinical trial with an active intervention
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inselspital, Bern University Hospital, Department of Cardiology Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.