Canakinumab for the Prevention of Recurrences of Atrial Fibrillation After Electrical Restoration of normal Heart rhythm in Patients With Atrial Fibrillation (CONVERT-AF)

Phase 1

• Conditions: Atrial Fibrillation; MedDRA version: 16.1Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-000530-29-DE
• Lead Sponsor: niversity Hospital Basel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-10
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

EKG-documented AF
Undergoing electrical cardioversion
C-reactive protein =2mg/L
Age = 50 years, women need to be postmenopausal
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

Undergoing urgent cardioversion because of medical instability
AF persistence after cardioversion or AF recurrence before randomization
Atrial flutter
Severe renal failure (creatinine clearance <30 ml/min)
Known active or recurrent hepatic disorder (including cirrhosis, hepatitis A, B or C, or ALT (Alanine transaminase)/AST (aspartate aminotransferase) levels >3x ULN or total bilirubin >2x ULN)
History of malignancy other than basal cell skin carcinoma
Known intolerance or allergic reactions to canakinumab
Use of amiodarone within the last 6 months
Known HIV or any other immune compromised state including neutropenia or immunodeficiency
History of ongoing, chronic or recurrent infectious disease
History or evidence of active tuberculosis (TB) infection at Visit 1 or one of the risk factors for tuberculosis such as but not limited or exclusive to:
-History of any of the following: residence in a congregate setting (e.g. jail or prison, homeless shelter, or chronic care facility), substance abuse (e.g. injection or noninjection), health-care workers with unprotected exposure to patients who are at high risk of TB or patients with TB disease before the identification and correct airborne precautions of the patient.
-Close contact (i.e. share the same air space in a household or other enclosed environment for a prolonged period (days or weeks, not minutes or hours)) with a person with active pulmonary TB disease within the last 12 months.
-Evidence of tuberculosis infection, at Visit 1, determined as defined by local guidelines/ local medical practice (see also below for determination of tuberculosis status). If presence of tuberculosis is established then treatment (according to local guidelines) must have been completed prior to randomization. Completion of treatment is determined by local TB guidelines or in the absence of such guidelines the following has to be demonstrated: TB has been treated adequately with antibiotics, cure can be demonstrated, and risk factors resulting in TB exposure and contracting TB have been removed (e.g. the patient does not live anymore in high TB exposure setting).
Patients on corticosteroids or other anti-inflammatory drugs other than non-steroidal anti-inflammatory drugs
Patients on any biological drug targeting the immune system
Known left ventricular ejection fraction <35%
Severe valvular heart disease
Acute coronary syndrome or acute stroke within 3 months
History of heart failure hospitalization within 3 months
Planned major surgery including planned coronary artery bypass grafting
Women of childbearing potential
Live vaccinations within 3 months prior to the randomization visit (visit 2) or live vaccinations planned during the trial.
Life expectancy <1 year
Inability to comply with the study protocol
Previously enrolled in CONVERT-AF
Patients who have received an investigational drug or device within 30 days of first visit.
History of alcohol and/or substance abuse that could interfere with the conduct of the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 6 Months;Main Objective: The main objective of the of the Study is to examine the efficacy and tolerance of the drug Ilaris® (Canakinumab) on patients with persistent atrial fibrillation. We want to examine if inhibiting the inflammatory response leads to a lower relapse rate of atrial fibrilation after successful electical cardioversion.;Secondary Objective: Not applicable;Primary end point(s): Time to Recurrences of Atrial Fibrillation within 6 Months After Electrical Cardioversion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time to first recurrence of atrial fibrillation within 1 month after cardioversion<br>Time to first recurrence of atrial fibrillation within 3 months after cardioversion<br>Time to first cardioversion within 6 months after index cardioversion<br>Use of antiarrhythmic drugs at 6 months follow-up<br>Survival free of unplanned hospitalisation<br>Change in C-reactive protein between inclusion and 6 month follow-up;Timepoint(s) of evaluation of this end point: 1 Month<br>3 Months<br>6 Months