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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
Sponsor:
Collaborator:
ACTION Institut de Cardiologie Pitié-Salpêtrière Hospital Paris, France
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Beta-blockers withdrawal Drug: Continuation of the Betablockers (βB) treatment Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Stroke [ Time Frame: up to 48 months ]
    Stroke

  3. 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)

  4. 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;


Other Outcome Measures:
  1. Cardiovascular death [ Time Frame: up to 48 months ]
    Cardiovascular death

  2. Syncope/dizziness requiring a consultation or a hospitalisation. [ Time Frame: up to 48 months ]
    Syncope/dizziness requiring a consultation or a hospitalisation.

  3. 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

  4. Angina control [ Time Frame: up to 48 months ]
    Angina control measured by the CCS grading scale

  5. Heart Rate Control [ Time Frame: first year only ]
    Heart Rate Control by Cardiac Frequency during visit

  6. Blood Pressure Control [ Time Frame: first year only ]
    Blood Pressure Control by Blood pressure during visit)

  7. An Episode of Heart failure [ Time Frame: up to 48 months ]
    An Episode of Heart failure (consultation or Hospitalisation)

  8. The quality of life (QoL) [ Time Frame: up to 48 months ]
    The questionnaire EQ5D-5L

  9. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects meeting all of the following criteria will be considered for enrolment into the study:

    1. Male or female 18 years of age
    2. Current treatment with βB whatever the drug or the dose used
    3. Prior documented acute myocardial infarction 6 months or more before randomisation defined either by:
  • a documented ST elevation MI with ST segment elevation and/or the presence of Q wave (Type I MI)
  • a documented episode of Non ST Elevation MI with at least one of the followings:

    • a documented hypokinetic or akinetic segment on echo or any other imaging technique
    • segmental hypoperfusion Thallium or any other imaging technique
    • segmental aspect of necrosis on MRI 4. Patient affiliated to French Social Security 5. Informed consent obtained in writing at enrolment into the study

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).

Information from the National Library of Medicine

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


Contacts
Contact: Johanne SILVAIN, MD-PhD 01 42 16 29 61 johanne.silvain@aphp.fr
Contact: Gilles MONTALESCOT, MD-PhD 01 42 16 30 07 gilles.montalescot@aphp.fr

Locations
France
Institut de Cardiologie - USIC - Hôpital Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: Johanne SILVAIN, MD    33 1 42 16 30 01    johanne.silvain@aphp.fr   
Contact: Gilles MONTALESCOT, MD, PhD    33 1 42 16 30 07    gilles.montalescot@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
ACTION Institut de Cardiologie Pitié-Salpêtrière Hospital Paris, France
Investigators
Study Chair: Johanne SILVAIN, MD-PhD APHP / Institut de Cardiologie, Pitié-Salpêtrière Hospital, Paris (APHP) / ACTION Study Group / Sorbonne Université Paris-France

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03498066     History of Changes
Other Study ID Numbers: P150946J
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Myocardial Infarction
Beta-Blockers
Stable Coronary Artery Disease

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs