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Persistent Atrial FibrillationPhase 2RAFFAELLONCT01534962

Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion

A Phase 2 study testing Ranolazine in people with Persistent Atrial Fibrillation, run by Menarini Group at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Dose-ranging Phase II study testing the efficacy and safety of 3 doses of Ranolazine (low, intermediate and high, given BID) versus placebo in maintaining sinus rhythm after successful electrical cardioversion in patients with persistent atrial fibrillation (AFib). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Persistent Atrial Fibrillation
What is being tested?
Ranolazine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
241 participants
Where
4 sitesin 4 countries
Study dates
Jan 2012to Mar 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Male or female patients 18 years and older
  • Patients with persistent AF suitable for electrical direct current cardioversion (DCC)
  • A female of childbearing potential may be enrolled providing she has a negative pregnancy test at baseline and is routinely using an effective method of birth control resulting in a low failure rate until end of study
  • Able to give written informed consent before any study related procedure
  • Able to attend all the visits scheduled in the study

Who cannot join

  • Patients with first diagnosed AF or patients with paroxysmal AF
  • Patients with long-standing persistent AF or permanent AF
  • Patients having known concurrent temporary secondary causes of AF such as alcohol intoxication, pulmonary embolism, hyperthyroidism, pneumonia, hypoxemia, acute pericarditis or myocarditis
  • Patients having undergone atrial catheter ablation for AF
  • Patients carrying a pacemaker
  • Patients with electrolytes imbalances that may cause cardiac arrhythmias, e.g. potassium < 3.5 mmol/L or > 5.5 mmol/L
Show all 15Show fewer
  • Patients with any contra-indications to Ranexa according to the drug-specific product characteristics
  • Patients taking class I or Class III antiarrhythmic agents within 3 days of planned randomisation
  • Patients taking beta-blockers unless used on stable doses for at least 2 weeks prior to the planned randomisation. Single doses of Intravenous beta-blockers are allowed up to 10 hours from the planned randomisation
  • Patients taking Dronedarone or oral Amiodarone within 2 weeks and 3 months of planned randomisation, respectively
  • Patients with a history of ECG abnormalities that in the opinion of the Investigator render the subject unsuitable for the trial, including history of congenital or a family history of long QT syndrome and a QTc interval ≥500 msec at Screening
  • Patients with congestive heart failure NYHA grade III and IV;
  • Patients with any serious intercurrent illness (including psychiatric and neurological disorders) which, in the opinion of the Investigator, is incompatible with the protocol.
  • Patients taking Metformin at a total daily dose greater than 1000 mg.
  • Patients taking Simvastatin at a total daily dose greater than 20 mg.

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Germany1 site

  • Universitätsmedizin Göttingen (UMG), Kardiologie und Pneumologie

    Göttingen, Lower Saxony, 37075

Other trials in Germany

Italy1 site

  • FONDAZIONE IRCCS, Dip. Cardiotoracovascolare (U.C.C.)

    Pavia, Lombardy, 27100

Other trials in Italy

Spain1 site

  • Hospital Clínic i Provincial de Barcelona, Servicio de Cardiología-Sección de Arritmias

    Barcelona, Catalonia, 08036

Other trials in Spain

United Kingdom1 site

  • St. George's University of London

    London, Greater London, SW17 0RE

Other trials in United Kingdom

About this study

Official title: A Randomised, Double-blind, Double-dummy, Placebo-controlled, Dose-ranging Phase II Study Assessing Ranolazine in the Maintenance of Sinus Rhythm After Electrical Cardioversion in Patients With Non-permanent Atrial Fibrillation.

Dose-ranging Phase II study testing the efficacy and safety of 3 doses of Ranolazine (low, intermediate and high, given BID) versus placebo in maintaining sinus rhythm after successful electrical cardioversion in patients with persistent atrial fibrillation (AFib).

After successful cardioversion and subsequent randomisation, patients report trans-telephonic EGCs on a daily basis to a central core ECG facility.

Maximum treatment duration is 112 days (16 weeks).

Read the detailed description

Patients with persistent AFib are screened for eligibility and undergo direct current cardioversion (DCC). If DCC is successful (defined as persistence of sinus rhythm 2 h post-DCC) patients meeting all the inclusion criteria and none of the exclusion criteria are randomly assigned to the treatment arms (Ranolazine low, intermediate, high dose or placebo, given BID).

Transtelephonic ECG devices (TT-ECG) are used for recording of AFib recurrence to be read by a Central ECG Core Laboratory. Any symptoms indicative of AFib have to be recorded by the patient in a diary.

Study Visits are held for screening (Visit 1), at DCC and randomisation (Visit 2), one week post DCC (Visit 3), after 8 weeks of treatment (Visit 4), and at end of treatment (Visit 5). A safety follow-up telephone call is held 2 weeks after end of treatment.

12-Lead ECGs are performed at every visit.

Safety evaluations include regular safety laboratory blood and urine tests, 12-lead ECGs and the continuous recording of adverse events.

A double-dummy technique is used to ensure double-blind conditions.

Being tested
Ranolazine, Placebo
Keywords
Atrial Fibrillation, Ranolazine, Arrhythmias, Cardiac, Antiarrhythmic Agents, Cardiac Electroversion, Ranexa
Medical subject headings
Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

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

  • RanolazineDrug

    Also called Ranexa (R)

    Oral administration, BID; for a maximum of 112 days.

  • RanolazineDrug

    Also called Ranexa (R)

    Oral administration, BID; for a maximum of 112 days.

  • RanolazineDrug

    Also called Ranexa (R)

    Oral administration, BID; for a maximum of 112 days.

  • PlaceboDrug

    Also called Sugar pill

    Oral administration, BID; for a maximum of 112 days.

Study groups in NCT01534962
Study groupRoleWhat they receive
Ranolazine low doseExperimentalRanolazine, low dose, oral, BID
Receives: Drug: Ranolazine
Ranolazine intermediate doseExperimentalRanolazine, intermediate dose, oral, BID
Receives: Drug: Ranolazine
Ranolazin high doseExperimentalRanolazine, high dose, oral, BID
Receives: Drug: Ranolazine
PlaceboPlacebo comparatorPlacebo (sugar pill), oral, BID.
Receives: Drug: Placebo

What is being measured

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

  1. Time From Randomization to First Documented AF Recurrence.

    Time to first AF recurrence reported by patient-reported TT-ECG or 12-Lead ECG at the study site, whichever occurred first.

    Patients discontinuing the study without AF were censored at the time of the last available ECG.

    Measured: 16 weeks (112 days)

Secondary outcomes (5)

  1. Number of Patients With Documented AF Recurrences

    Measured: 16 weeks (112 days)

  2. Time From Randomization to First Documented and Confirmed AF Recurrence

    A confirmed AF recurrence was defined as a documented AF recurrence which was confirmed by a consecutive ECG performed at least 1 hour after first AF documentation.

    Measured: 16 weeks (112 days)

  3. Number of Patients With Documented and Confirmed AF Recurrences

    Measured: 16 weeks (112 days)

  4. Time From Randomization to First Documented AF Recurrence in Patients With Sinus Rhythm 48 Hours After Cardioversion

    Excluding patients with early relapses (within 48 hours) while the study drug, started after cardioversion, had not yet reached steady-state.

    Measured: 16 weeks (112 days)

  5. Number of Patients in Sinus Rhythm 48 Hours After Cardioversion With Documented AF Recurrence

    Documented AF recurrences in those patients who did not experience early relapses (within 48 hours after cardioversion)

    Measured: 16 weeks (112 days)

Timeline

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

  1. First posted17 Feb 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionOct 2013
  4. Study completionMar 2014

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
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01534962
Sponsor's protocol ID
RAF-01
Other IDs
2011-002789-18
Acronym
RAFFAELLO
Status last verified
Jul 2014
First submitted
10 Feb 2012
Last updated
19 Aug 2014
Data monitoring committee
No

Publications

  • De Ferrari GM, Maier LS, Mont L, Schwartz PJ, Simonis G, Leschke M, Gronda E, Boriani G, Darius H, Guillamon Toran L, Savelieva I, Dusi V, Marchionni N, Quintana Rendon M, Schumacher K, Tonini G, Melani L, Giannelli S, Alberto Maggi C, Camm AJ; RAFFAELLO Investigators (see Online Supplementary Appendix for List of Participating Centers and Investigators). Ranolazine in the treatment of atrial fibrillation: Results of the dose-ranging RAFFAELLO (Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion) study. Heart Rhythm. 2015 May;12(5):872-8. doi: 10.1016/j.hrthm.2015.01.021. Epub 2015 Jan 17.

    PubMed 25602175

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ranolazine in people with Persistent Atrial Fibrillation, run by Menarini Group at 4 sites in 4 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 5 inclusion and 15 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: finished, as of the sponsor's last update on 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany, Italy, Spain, United Kingdom. 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?

Yes. Results are posted in the registry (first posted 19 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time From Randomization to First Documented AF Recurrence. (time frame: 16 weeks (112 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 NCT01534962, which also lists 1 linked publication.

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 19 Aug 2014.

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