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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canakinumab | Experimental | 1 s.c. injection of canakinumab 150mg directly after cardioversion |
|
| Placebo | Placebo Comparator | 1 s.c. injection directly after cardioversion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canakinumab | Biological |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of atrial fibrillation | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of atrial fibrillation | 90 days | |
| Change in plasma levels of C-reactive protein | 180 days | |
| Time to first redo cardioversion |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| David Conen, Prof. | Cardiology, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Heart Center Hamburg | Hamburg | Germany | ||||
| Department of Medicine, University Hospital |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C541220 | canakinumab |
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|
| 180 days |
| Basel |
| Basel |
| 4031 |
| Switzerland |
| HUG Geneve | Geneva | Switzerland |
| CHUV Lausanne | Lausanne | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | Switzerland |
| D013568 |
| Pathological Conditions, Signs and Symptoms |