Clinical trial NCT01805960: Canakinumab for the Prevention of Recurrences After Electrical Cardioversion: CONVERT-AF
Official title: Canakinumab for the Prevention of Recurrences After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation (CONVERT-AF) Trial - A Randomized Double Blind Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of atrial fibrillation
timeFrame: 180 days
Secondary outcomes:
measure: Recurrence of atrial fibrillation
timeFrame: 90 days
measure: Change in plasma levels of C-reactive protein
timeFrame: 180 days
measure: Time to first redo cardioversion
timeFrame: 180 days
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Heart Center Hamburg
city: Basel
country: Switzerland
facility: Department of Medicine, University Hospital
city: Geneve
country: Switzerland
facility: HUG Geneve
city: Lausanne
country: Switzerland
facility: CHUV Lausanne
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
Study officials:
affiliation: Cardiology, University Hospital Basel
name: David Conen, Prof.
role: PRINCIPAL_INVESTIGATOR
References: