NCT01805960

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 atrial-fibrillation

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_2 atrial-fibrillation

Geographic Reach
2 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

3.5 years

First QC Date

March 5, 2013

Last Update Submit

February 13, 2017

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Recurrence of atrial fibrillation

    180 days

Secondary Outcomes (3)

  • Recurrence of atrial fibrillation

    90 days

  • Change in plasma levels of C-reactive protein

    180 days

  • Time to first redo cardioversion

    180 days

Study Arms (2)

Canakinumab

EXPERIMENTAL

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

Biological: Canakinumab

Placebo

PLACEBO COMPARATOR

1 s.c. injection directly after cardioversion

Biological: Placebo

Interventions

CanakinumabBIOLOGICAL
Canakinumab
PlaceboBIOLOGICAL
Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • EKG-documented AF
  • Undergoing electrical cardioversion
  • C-reactive protein ≥1.25mg/L
  • Age ≥ 50 years, women need to be postmenopausal

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Heart Center Hamburg

Hamburg, Germany

Location

Department of Medicine, University Hospital

Basel, Basel, 4031, Switzerland

Location

HUG Geneve

Geneva, Switzerland

Location

CHUV Lausanne

Lausanne, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Conen, Prof.

    Cardiology, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 6, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

DE(1)CH(4)