Canakinumab for the Prevention of Recurrences After Electrical Cardioversion: CONVERT-AF (CONVERT-AF)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Canakinumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
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
Sites / Locations
- University Heart Center Hamburg
- Department of Medicine, University Hospital
- HUG Geneve
- CHUV Lausanne
- Kantonsspital St. Gallen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Canakinumab
Placebo
Arm Description
1 s.c. injection of canakinumab 150mg directly after cardioversion
1 s.c. injection directly after cardioversion
Outcomes
Primary Outcome Measures
Recurrence of atrial fibrillation
Secondary Outcome Measures
Recurrence of atrial fibrillation
Change in plasma levels of C-reactive protein
Time to first redo cardioversion
Full Information
NCT ID
NCT01805960
First Posted
March 5, 2013
Last Updated
February 13, 2017
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT01805960
Brief Title
Canakinumab for the Prevention of Recurrences After Electrical Cardioversion: CONVERT-AF
Acronym
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Canakinumab
Arm Type
Experimental
Arm Description
1 s.c. injection of canakinumab 150mg directly after cardioversion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 s.c. injection directly after cardioversion
Intervention Type
Biological
Intervention Name(s)
Canakinumab
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Recurrence of atrial fibrillation
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Recurrence of atrial fibrillation
Time Frame
90 days
Title
Change in plasma levels of C-reactive protein
Time Frame
180 days
Title
Time to first redo cardioversion
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Conen, Prof.
Organizational Affiliation
Cardiology, University Hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Heart Center Hamburg
City
Hamburg
Country
Germany
Facility Name
Department of Medicine, University Hospital
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
HUG Geneve
City
Geneve
Country
Switzerland
Facility Name
CHUV Lausanne
City
Lausanne
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Canakinumab for the Prevention of Recurrences After Electrical Cardioversion: CONVERT-AF
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