AzTrials
AzTrials

Myocardial InfarctionPhase 4AβYSSNCT03498066

Beta Blocker Interruption After Uncomplicated Myocardial Infarction

A Phase 4 study testing Beta-blockers withdrawal and Continuation of the Betablockers (βB) treatment in people with Myocardial Infarction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

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

Official record
Search all trials

Trial summary

ABYSS is a national, multicenter, randomised, open label trial using the PROBE study design, that will evaluate the non-inferiority of the interruption of ΒB therapy after an uncomplicated MI after six months or more of follow-up compared to the continuation of βB evaluated by the primary endpoint or death, MI, Stroke… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction
What is being tested?
Beta-blockers withdrawal and Continuation of the Betablockers (βB) treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,700 participants
Where
1 siteFrance
Study dates
29 Aug 2018to 31 Oct 2023
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects meeting all of the following criteria will be considered for enrolment into the study:
  • Male or female +/=18 years of age
  • Current treatment with βB whatever the drug or the dose used
  • Prior acute myocardial infarction 6 months or more before randomisation defined either by:
  • AβYSS protocol, version 3.0 of 25/05/2021 Page 32 / 65
  • An episode of ST elevation MI with ST segment elevation (STEMI) and/or the presence of Q wave (Type I MI)
Show all 13Show fewer
  • an episode of Non ST Elevation MI (NSTEMI) with preferably at least one of the followings:
  • i) a documented hypokinetic or akinetic segment on echo or any other imaging technique
  • ii) segmental hypoperfusion Thallium or any other imaging technique
  • iii) segmental aspect of necrosis on MRI
  • An episode of silent MI discovered on ECG or Cardiac Imaging. Importantly = The mention of an MI on a report is enough to be considered as a prior MI and it is not necessary to retrieve the source document and/or documentation of this prior MI .
  • Patient affiliated to Social Security
  • Informed consent obtained in writing at enrolment into the study

Who cannot join

  • Subjects presenting with any of the following will not be included in the study:
  • Uncontrolled arterial hypertension according to investigator decision
  • Prior episode of heart failure in the past two years of follow-up and/or low left ventricular ejection fraction <40% requiring the use of βB;
  • New ACS (in the past 6 months) including UA/NSTEMI and STEMI;
  • Persistent angina or ischemia (>10% viable myocardium) requiring the use of βB;
  • Prior episode of ventricular or supraventricular arrhythmia in the past year of follow-up requiring the use of ΒB;
Show all 9Show fewer
  • Treatment with other investigational agents or devices within the previous 30 days, or previous enrolment in this trial.
  • Pregnant Women or breast feeding women
  • Patient under legal protection (protection of the court, or in curatorship or guardianship).

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut de Cardiologie - USIC - Hôpital Pitié-Salpêtrière

    Paris, 75013

Other trials in France

About this study

Official title: Assessment of βeta Blocker Interruption After Uncomplicated mYocardial Infarction on Safety and Symptomatic Cardiac Events Requiring Hospitalization: The AβYSS Study

ABYSS is a national, multicenter, randomised, open label trial using the PROBE study design, that will evaluate the non-inferiority of the interruption of ΒB therapy after an uncomplicated MI after six months or more of follow-up compared to the continuation of βB evaluated by the primary endpoint or death, MI, Stroke and rehospitalization for others cardiovascular reasons.

Read the detailed description

Despite the outstanding progress made in cardiac care over the last few years, cardiovascular diseases remain the leading cause of morbidity and mortality in developed countries.

After the initial clinical event, patients are considered to have a chronic disease which combined with the increasing actual life expectancy patients with CAD are a major source of expenses due to their life-long treatment and follow-up.

ΒB are prescribed during the initial hospitalisation for MI and in the post-MI phase. European (European Society of Cardiology, ESC) and American (ACC/AHA) guidelines initially gave βB therapy a class I recommendation for MI or acute coronary syndrome (ACS) for the first year of treatment and extended such recommendation without solid data up to 3 years after MI , . However, there has been no recent clinical trial to evaluate safety and efficacy of long term ΒB therapy in the contemporary therapeutic era. Taking such lack of evidence in account and acknowledging that clinical practice has changed, the latest ESC STEMI (2014) and NSTEMI (2015) Guidelines degraded the recommendation for the use of ΒB in post MI patients (Class IIa B) during the hospitalization period and they question the validity of its use after the initial stabilization phase. This was confirmed in the 2017 STEMI Guidelines.

The primary objective of the ABYSS trial is to demonstrate the non-inferiority of the interruption of ΒB therapy after an uncomplicated MI after six months or more of follow-up compared to the continuation of βB evaluated by the primary endpoint.

The primary endpoint of the study will be evaluated, with one-year minimum follow-up, and will be the composite of Major Adverse Cardiovascular Events (MACE) measured at the longest follow-up including:

  • All-cause death
  • Stroke
  • Myocardial infarction Hospitalisation for other cardiovascular (CV) reason.

It is expected that the interruption of βB therapy will not alter the prognosis of patients and improve safety and quality of life of patients and considerably reduce healthcare direct or indirect costs.

Being tested
Beta-blockers withdrawal, Continuation of the Betablockers (βB) treatment
Keywords
Myocardial Infarction, Beta-Blockers, Stable Coronary Artery Disease
Medical subject headings
Myocardial Infarction

What participants receive

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

  • Beta-blockers withdrawalDrug

    withdrawal of all type of betablockers

  • Continuation of the Betablockers (βB) treatmentDrug

    Use Betablockers treatment

Study groups in NCT03498066
Study groupRoleWhat they receive
Discontinuation of the Betablockers (βB)Experimental1850 post-MI patients treated with chronic βB treatment will undergo withdrawal of their βB treatment..
Receives: Drug: Beta-blockers withdrawal
Continuation of the Betablockers (βB)Active comparator1850 post-MI patients treated with chronic βB treatment will be continued under their usual βB treatment without modification.
Receives: Drug: Continuation of the Betablockers (βB) treatment

What is being measured

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

  1. The composite of Major Adverse Cardiovascular Events (MACE)

    Will be evaluated with one-year minimum follow-up and will be the composite of Major Adverse Cardiovascular Events (MACE) including:

    • All-cause death
    • Myocardial infarction (MI)
    • Stroke
    • Hospitalisation for any cardiovascular (CV) reason.

    Measured: Through study completion, with a minimum of 1 year

Secondary outcomes (1)

  1. Quality of life

    will be evaluated by the questionnaire EQ5D-5L Score (0 to 1) and EQ5D-5L Scale (0 to 100) with higher scores indicating a better quality of Life.

    Measured: Through study completion, with a minimum of 1 year

Timeline

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

  1. First posted13 Apr 2018
  2. Study start29 Aug 2018
  3. Primary completion31 Oct 2023
  4. Study completion31 Oct 2023

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03498066
Sponsor's protocol ID
P150946J
Acronym
AβYSS
Status last verified
Nov 2023
First submitted
21 Mar 2018
Last updated
6 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available

Publications

  • Silvain J, Cayla G, Ferrari E, Range G, Puymirat E, Delarche N, Collet JP, Dumaine R, Slama M, Payot L, Kasty ME, Aacha K, Vicaut E, Montalescot G; ABYSS investigators of the ACTION Study Group,. betaeta blocker interruption after uncomplicated myocardial infarction: rationale and design of the randomized ABYSS trial. Am Heart J. 2023 Apr;258:168-176. doi: 10.1016/j.ahj.2023.01.014. Epub 2023 Jan 20.

    PubMed 36682596

  • Silvain J, Cayla G, Ferrari E, Range G, Puymirat E, Delarche N, Guedeney P, Cuisset T, Ivanes F, Lhermusier T, Petroni T, Lemesle G, Bresoles F, Labeque JN, Pommier T, Dillinger JG, Leclercq F, Boccara F, Lim P, Besseyre des Horts T, Fourme T, Jourda F, Furber A, Lattuca B, Redjimi N, Thuaire C, Deharo P, Procopi N, Dumaine R, Slama M, Payot L, El Kasty M, Aacha K, Diallo A, Vicaut E, Montalescot G; ABYSS Investigators of the ACTION Study Group. Beta-Blocker Interruption or Continuation after Myocardial Infarction. N Engl J Med. 2024 Oct 10;391(14):1277-1286. doi: 10.1056/NEJMoa2404204. Epub 2024 Aug 30.

    PubMed 39213187

  • Granger CB, Pocock SJ, Gersh BJ. The need for new clinical trials of old cardiovascular drugs. Nat Rev Cardiol. 2023 Feb;20(2):71-72. doi: 10.1038/s41569-022-00819-1. No abstract available.

    PubMed 36526898

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Beta-blockers withdrawal and Continuation of the Betablockers (βB) treatment in people with Myocardial Infarction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 13 inclusion and 9 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 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The composite of Major Adverse Cardiovascular Events (MACE) (time frame: Through study completion, with a minimum of 1 year). 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 NCT03498066, which also lists 3 linked publications.

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 6 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in