Canakinumab for the Prevention of Recurrences After Electrical Cardioversion: CONVERT-AF

University Hospital Basel

Status and phase

Terminated

Phase 2

Conditions

Atrial Fibrillation

Treatments

Biological: Placebo

Biological: Canakinumab

Study type

Interventional

Funder types

Other

Identifiers

NCT01805960

CONVERT-AF Version5 22.01.2013

Details and patient eligibility

About

The purpose of this study is to test the efficacy of a single injection of Canakinumab on AF recurrences within 6 months after electrical cardioversion in patients with persistent AF.

Enrollment

24 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

EKG-documented AF
Undergoing electrical cardioversion
C-reactive protein ≥1.25mg/L
Age ≥ 50 years, women need to be postmenopausal

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 Alanine transaminase/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 systemic corticosteroids or other anti-inflammatory drugs other than non-steroidal anti-inflammatory drugs
Patients on any biological drug targeting the immune system
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