Beta Blocker Interruption After Uncomplicated Myocardial Infarction (AβYSS)
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|ClinicalTrials.gov Identifier: NCT03498066|
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : September 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Drug: Beta-blockers withdrawal Drug: Continuation of the Betablockers (βB) treatment||Phase 4|
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
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of βeta Blocker Interruption After Uncomplicated mYocardial Infarction on Safety and Symptomatic Cardiac Events Requiring Hospitalization: The AβYSS Study|
|Actual Study Start Date :||August 29, 2018|
|Estimated Primary Completion Date :||August 29, 2023|
|Estimated Study Completion Date :||August 29, 2023|
Experimental: Discontinuation of the Betablockers (βB)
1850 post-MI patients treated with chronic βB treatment will undergo withdrawal of their βB treatment..
Drug: Beta-blockers withdrawal
withdrawal of all type of betablockers
Active Comparator: Continuation of the Betablockers (βB)
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
Use Betablockers treatment
- The composite of Major Adverse Cardiovascular Events (MACE) [ Time Frame: up to 48 months ]including: All-cause death Stroke Myocardial infarction Hospitalisation for other cardiovascular (CV) reason
- All individual parameters of MACE [ Time Frame: up to 48 months ]
All cause death
- Heart Failure
- Arrythmia = Ventricular or Supra-Ventricular Tachycardia
- Syncope, Conduction disorders or PaceMaker Implantation
- High Blood Pressure
- Stroke [ Time Frame: up to 48 months ]Stroke
- Myocardial Infarction (MI) (Classified by type of MI, including Stent Thrombosis) [ Time Frame: up to 48 months ]Myocardial Infarction (MI) (Classified by type of MI, including Stent Thrombosis)
- Hospitalisation for other CV reason [ Time Frame: up to 48 months ]Angina, Recurrent ischemia, Coronary Angiography or Coronary; Revascularisation outside of the scope of an MI; Heart Failure; Arrythmia = Ventricular or Supra-Ventricular Tachycardia; Syncope, Conduction disorders or PaceMaker Implantation; High Blood Pressure;
- Cardiovascular death [ Time Frame: up to 48 months ]Cardiovascular death
- Syncope/dizziness requiring a consultation or a hospitalisation. [ Time Frame: up to 48 months ]Syncope/dizziness requiring a consultation or a hospitalisation.
- Invasive procedures (catheterisation, percutaneous coronary intervention (PCI), pace-maker or automatic defibrillator implantation, endoscopy…) [ Time Frame: up to 48 months ]Invasive procedures (catheterisation, percutaneous coronary intervention
- Angina control [ Time Frame: up to 48 months ]Angina control measured by the CCS grading scale
- Heart Rate Control [ Time Frame: first year only ]Heart Rate Control by Cardiac Frequency during visit
- Blood Pressure Control [ Time Frame: first year only ]Blood Pressure Control by Blood pressure during visit)
- An Episode of Heart failure [ Time Frame: up to 48 months ]An Episode of Heart failure (consultation or Hospitalisation)
- The quality of life (QoL) [ Time Frame: up to 48 months ]The questionnaire EQ5D-5L
- The composite of: [ Time Frame: up to 48 months ]
- Any Death and MI
- CV death, MI, and stroke.
- CV death, MI, and urgent coronary revascularisation.
- CV death, MI, and recurrent ischemia requiring hospitalisation (with or without revascularisation).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498066
|Contact: Johanne SILVAIN, MD-PhD||01 42 16 29 firstname.lastname@example.org|
|Contact: Gilles MONTALESCOT, MD-PhD||01 42 16 30 email@example.com|
|Institut de Cardiologie - USIC - Hôpital Pitié-Salpêtrière||Recruiting|
|Paris, France, 75013|
|Contact: Johanne SILVAIN, MD 33 1 42 16 30 01 firstname.lastname@example.org|
|Contact: Gilles MONTALESCOT, MD, PhD 33 1 42 16 30 07 email@example.com|
|Study Chair:||Johanne SILVAIN, MD-PhD||APHP / Institut de Cardiologie, Pitié-Salpêtrière Hospital, Paris (APHP) / ACTION Study Group / Sorbonne Université Paris-France|