Beta Blocker Interruption After Uncomplicated Myocardial Infarction

Phase 4

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: Continuation of the Betablockers (βB) treatment; Drug: Beta-blockers withdrawal

• Registration Number: NCT03498066
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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.

Study Timeline

• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-13
• Study Start: 2018-08-29
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3700

Inclusion Criteria

Not provided

Exclusion Criteria

• Subjects presenting with any of the following will not be included in the study:

  1. Uncontrolled arterial hypertension according to investigator decision
  2. 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;
  3. New ACS (in the past 6 months) including UA/NSTEMI and STEMI;
  4. Persistent angina or ischemia (>10% viable myocardium) requiring the use of βB;
  5. Prior episode of ventricular or supraventricular arrhythmia in the past year of follow-up requiring the use of ΒB;
  6. Treatment with other investigational agents or devices within the previous 30 days, or previous enrolment in this trial.
  7. Pregnant Women or breast feeding women
  8. Patient under legal protection (protection of the court, or in curatorship or guardianship).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuation of the Betablockers (βB)	Continuation of the Betablockers (βB) treatment	1850 post-MI patients treated with chronic βB treatment will be continued under their usual βB treatment without modification.
Discontinuation of the Betablockers (βB)	Beta-blockers withdrawal	1850 post-MI patients treated with chronic βB treatment will undergo withdrawal of their βB treatment..

Primary Outcome Measures

Name	Time	Method
The composite of Major Adverse Cardiovascular Events (MACE)	Through study completion, with a minimum of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life	Through study completion, with a minimum of 1 year	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.

Trial Locations

Locations (1)

Institut de Cardiologie - USIC - Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France