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临床试验/NCT03498066
NCT03498066已完成4 期

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

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 3,700 人开始时间: 2018年8月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
3,700
试验地点
1
主要终点
The composite of Major Adverse Cardiovascular Events (MACE)

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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).

研究组 & 干预措施

Discontinuation of the Betablockers (βB)

Experimental

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

干预措施: Beta-blockers withdrawal (Drug)

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.

干预措施: Continuation of the Betablockers (βB) treatment (Drug)

结局指标

主要结局

The composite of Major Adverse Cardiovascular Events (MACE)

时间窗: 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.

次要结局

  • Quality of life(Through study completion, with a minimum of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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