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)
Zusammenfassung der Studie
In this study, the effect of the anti-inflammatory drug colchicine for the prevention of atrial fibrillation and pacemaker implantation after minimally invasive aortic valve implantation in patients with severe aortic stenosis is investigated. Atrial fibrillation is a life-threatening and unfortunately common complication after aortic valve implantation and may lead to the need for additional anticoagulation to avoid strokes. Various studies on surgical aortic valve replacement in patients with severe aortic stenosis have shown that colchicine can reduce the occurrence of new atrial fibrillation. In this study, we now want to investigate the efficacy of colchicine also in minimally invasive (transcatheter) aortic valve implantations. Colchicine is an anti-inflammatory agent and is not marketed in Switzerland, but has been used in many other countries (such as Germany) for many years for acute gout attacks and other inflammatory diseases. Colchicine is derived from the seeds of the autumn crocus and was first isolated in 1833. Colchicine inhibits the cell division of certain immune cells, which in turn leads to a strong anti-inflammatory effect.
(BASEC)
Untersuchte Intervention
The study is randomized. This means that participants are randomly assigned to one of the treatment groups. They will be assigned either to colchicine or to a placebo with a probability of 50% (coin toss). The study medication/placebo will be taken for 14 days, namely on the day before the aortic valve implantation, on the day of the procedure, and for 12 days after the procedure. The study participant and the study staff will not know which treatment group the study participants are assigned to.
(BASEC)
Untersuchte Krankheit(en)
Severe aortic stenosis, for which a minimally invasive (transcatheter) aortic valve implantation is indicated.
(BASEC)
- 65 years or older - Severe aortic stenosis, for which a minimally invasive (transcatheter) aortic valve implantation is indicated. (BASEC)
Ausschlusskriterien
- Inflammatory bowel disease - Severe kidney disease - Life expectancy of less than one year (BASEC)
Studienstandort
Bern
(BASEC)
Sponsor
Insel Gruppe AG, Inselspital Bern, Universitätsklinik für Kardiologie
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Thomas Pilgrim
00416325000
kardio.studien@clutterinsel.chInsel Gruppe AG, Inselspital Bern, Universitätsklinik für Kardiologie
(BASEC)
Allgemeine Auskünfte
University of Bern, Switzerland
(ICTRP)
Wissenschaftliche Auskünfte
University of Bern, Switzerland
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
17.09.2021
(BASEC)
ICTRP Studien-ID
NCT04870424 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Colchicine for patients with aortic stenosis undergoing transcatheter aortic valve replacement (Co-STAR): a randomized-controlled trial (BASEC)
Wissenschaftlicher Titel
Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement (Co-STAR): a Randomized-controlled Trial (ICTRP)
Öffentlicher Titel
Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement (ICTRP)
Untersuchte Krankheit(en)
Transcatheter Aortic Valve Replacement;Atrial Fibrillation New Onset;Pacemaker;Colchicine (ICTRP)
Untersuchte Intervention
Drug: Colchicine;Drug: Placebo (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Thomas Pilgrim, Prof., University of Bern, Switzerland (ICTRP)
Sekundäre IDs
Co-STAR (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04870424 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar