Status:
COMPLETED
Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Transcatheter Aortic Valve Replacement
Atrial Fibrillation New Onset
Eligibility:
All Genders
65+ years
Phase:
PHASE3
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-...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
September 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04870424
Start Date
September 21 2021
End Date
June 3 2025
Last Update
June 22 2025
Active Locations (1)
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1
Inselspital, Bern University Hospital, Department of Cardiology
Bern, Switzerland, 3010