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Atrial FibrillationPhase 2CONVERT-AFNCT01805960

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

A Phase 2 study testing Canakinumab in people with Atrial Fibrillation, run by University Hospital, Basel, Switzerland at 5 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Canakinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
5 sitesin 2 countries
Study dates
Jun 2013to Dec 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 26Show fewer
  • 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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Switzerland4 sites

  • Department of Medicine, University Hospital

    Basel, Basel, 4031

  • HUG Geneve

    Geneva

  • CHUV Lausanne

    Lausanne

  • Kantonsspital St. Gallen

    Sankt Gallen

Other trials in Switzerland

Germany1 site

  • University Heart Center Hamburg

    Hamburg

Other trials in Germany

About this study

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

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.

Being tested
Canakinumab, Placebo
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CanakinumabBiological

  • PlaceboBiological

Study groups in NCT01805960
Study groupRoleWhat they receive
CanakinumabExperimental1 s.c. injection of canakinumab 150mg directly after cardioversion
Receives: Biological: Canakinumab
PlaceboPlacebo comparator1 s.c. injection directly after cardioversion
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence of atrial fibrillation

    Measured: 180 days

Secondary outcomes (3)

  1. Recurrence of atrial fibrillation

    Measured: 90 days

  2. Change in plasma levels of C-reactive protein

    Measured: 180 days

  3. Time to first redo cardioversion

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01805960
Sponsor's protocol ID
CONVERT-AF Version5 22.01.2013
Acronym
CONVERT-AF
Status last verified
Feb 2017
First submitted
5 Mar 2013
Last updated
14 Feb 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Canakinumab in people with Atrial Fibrillation, run by University Hospital, Basel, Switzerland at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Switzerland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence of atrial fibrillation (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01805960.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.

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