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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01805960
First received: March 5, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Biological: Canakinumab
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Recurrence of atrial fibrillation [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence of atrial fibrillation [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Change in plasma levels of C-reactive protein [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Time to first redo cardioversion [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Canakinumab
1 s.c. injection of canakinumab 150mg directly after cardioversion
Biological: Canakinumab
Placebo Comparator: Placebo
1 s.c. injection directly after cardioversion
Biological: Placebo

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • EKG-documented AF
  • Undergoing electrical cardioversion
  • C-reactive protein ≥2mg/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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01805960

Contacts
Contact: David Conen, Prof. MD +41 61 328 66 96 david.conen@usb.ch

Locations
Switzerland
Department of Medicine, University Hospital Recruiting
Basel, Switzerland, 4031
Contact: David Conen, Prof.    +41 61 328 66 96    david.conen@usb.ch   
Principal Investigator: Christian Sticherling, Prof.         
Kantonsspital St. Gallen Recruiting
St. Gallen, Switzerland
Contact: Peter Ammann       peter.ammann@kssg.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: David Conen, Prof. Cardiology, University Hospital Basel
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01805960     History of Changes
Other Study ID Numbers: CONVERT-AF Version5 22.01.2013
Study First Received: March 5, 2013
Last Updated: August 19, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Cardiovascular Diseases
Disease Attributes
Heart Diseases
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014