NCT03498066

Brief 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 and rehospitalization for others cardiovascular reasons.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,700

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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 21, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

August 29, 2018

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

5.2 years

First QC Date

March 21, 2018

Last Update Submit

November 30, 2023

Conditions

Myocardial Infarction

Keywords

Myocardial InfarctionBeta-BlockersStable Coronary Artery Disease

Outcome Measures

Primary Outcomes (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.

    Through study completion, with a minimum of 1 year

Secondary Outcomes (1)

  • Quality of life

    Through study completion, with a minimum of 1 year

Other Outcomes (5)

  • Anxiety and Depression

    Through study completion, with a minimum of 1 year

  • Erection Dysfunction

    Through study completion, with a minimum of 1 year

  • Libido

    Through study completion, with a minimum of 1 year

  • +2 more other outcomes

Study Arms (2)

Discontinuation of the Betablockers (βB)

EXPERIMENTAL

1850 post-MI patients treated with chronic βB treatment will undergo withdrawal of their βB treatment..

Drug: Beta-blockers withdrawal

Continuation of the Betablockers (βB)

ACTIVE COMPARATOR

1850 post-MI patients treated with chronic βB treatment will be continued under their usual βB treatment without modification.

Drug: Continuation of the Betablockers (βB) treatment

Interventions

Beta-blockers withdrawalDRUG

withdrawal of all type of betablockers

Discontinuation of the Betablockers (βB)
Continuation of the Betablockers (βB) treatmentDRUG

Use Betablockers treatment

Continuation of the Betablockers (βB)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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;
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cardiologie - USIC - Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (3)

  • 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.

    PMID: 36682596RESULT

  • 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.

    PMID: 39213187DERIVED

  • 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.

    PMID: 36526898DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Johanne SILVAIN, MD-PhD

    APHP / Institut de Cardiologie, Pitié-Salpêtrière Hospital, Paris (APHP) / ACTION Study Group / Sorbonne Université Paris-France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2018

First Posted

April 13, 2018

Study Start

August 29, 2018

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

December 6, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available

Locations

FR(1)