Study on the prevention of atrial fibrillation and pacemaker implantation by colchicine after minimally invasive aortic valve implantation in patients with severe aortic stenosis (Co-STAR Study)

Switzerland (ICTRP)

ICTRP Trial ID
NCT04870424 (ICTRP)

Official title (approved by ethics committee)
Colchicine for patients with aortic stenosis undergoing transcatheter aortic valve replacement (Co-STAR): a randomized-controlled trial (BASEC)

Academic title
Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement (Co-STAR): a Randomized-controlled Trial (ICTRP)

Public title
Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement (ICTRP)

Disease under investigation
Transcatheter Aortic Valve Replacement;Atrial Fibrillation New Onset;Pacemaker;Colchicine (ICTRP)

Intervention under investigation
Drug: Colchicine;Drug: Placebo (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)

Inclusion/Exclusion criteria
Gender: All
Maximum age: N/A
Minimum age: 65 Years
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. (ICTRP)

not available

Primary and secondary end points
Incidence rate of the composite of new onset atrial fibrillation or occurrence of conduction disturbances requiring the implantation of a permanent pacemaker (ICTRP)

Single components of primary composite endpoint;The incidence of conductance disturbances;The predictors of conductance disturbances;The incidence of new arrhythmias resulting in hemodynamic instability or requiring therapy;Inflammatory marker levels;The proportion of patients with at least one prosthetic leaflet with > 50% motion reduction or with at least one prosthetic leaflet with thickening;The proportion of prosthetic leaflets with > 50% motion reduction or leaflet thickening;The incidences of major clinical adverse events (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
Thomas Pilgrim, Prof., University of Bern, Switzerland (ICTRP)

Secondary trial IDs
Co-STAR (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT04870424 (ICTRP)