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

NCT ID: NCT01805960

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-12-31

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Canakinumab

1 s.c. injection of canakinumab 150mg directly after cardioversion

Group Type: EXPERIMENTAL

Canakinumab

Intervention Type: BIOLOGICAL

Placebo

1 s.c. injection directly after cardioversion

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Interventions

Canakinumab

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Conen, Prof.

Role: PRINCIPAL_INVESTIGATOR

Cardiology, University Hospital Basel

Locations

University Heart Center Hamburg

Hamburg, , Germany

Department of Medicine, University Hospital

Basel, Basel, Switzerland

HUG Geneve

Geneva, , Switzerland

CHUV Lausanne

Lausanne, , Switzerland

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Countries

Germany; Switzerland

Other Identifiers

CONVERT-AF Version5 22.01.2013

Identifier Type: -

Identifier Source: org_study_id