Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement

NCT ID: NCT04870424

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-21
• Study Completion Date: 2025-06-03

Brief 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. 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.

Conditions

Transcatheter Aortic Valve Replacement; Atrial Fibrillation New Onset; Pacemaker; Colchicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Colchicine

Group Type: EXPERIMENTAL

Colchicine

Intervention Type: DRUG

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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

Colchicine

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 65 years

2. 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

3. Selected to undergo transfemoral TAVI based on heart team decision

Exclusion Criteria

1. Life expectancy <1 year irrespective of valvular heart disease

2. Kidney disease with a creatinine clearance ≤30 ml/min

3. Known severe liver disease

4. Known neuromuscular disease

5. Clinically significant anaemia with haemoglobin <80g/L

6. Known inflammatory bowel disease or chronic diarrhea

7. Known ongoing bacterial infection

8. Known galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

9. Current treatment with colchicine, steroids or biologicals for any indication

10. Concomitant intake of Cyclosporine, Amiodarone, Clarithromycin, Erythromycin, Omeprazole, Verapamil or other strong inhibitors of CYP3A4 or P-Glycoprotein

11. Concomitant intake of Carbamazepin, Phenobarbital, Phenytoin, Rifampicin or other strong inductors of CYP3A4 and P-Glycoprotein

12. Permanent pacemaker or implantable cardioverter defibrillator

13. History of atrial fibrillation

14. Absence of sinus rhythm on hospital admission

15. Planned non-cardiac surgery within 30 days

16. Known intolerance to colchicine

17. Inability to provide written informed consent

18. Known or suspected non-compliance, drug or alcohol abuse

19. Participation in another clinical trial with an active intervention

20. 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Pilgrim, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Bern, Switzerland

Locations

Inselspital, Bern University Hospital, Department of Cardiology

Bern, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 40659682 (View on PubMed)

Other Identifiers

Co-STAR

Identifier Type: -

Identifier Source: org_study_id