Influenza Vaccine to reduce cardiovascular events in patients with recent myocardial infarction: a multicentric randomized, double-blind palcebo-controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3,600
- 试验地点
- 9
- 主要终点
- The primary outcome will be a composite of all cause death, non-fatal myocardial infarction, non-fatal stroke and all-cause hospitalizations using standardized criteria from time of randomization during the peak influenza season.
研究概览
简要总结
Rationale: Influenza is known to trigger acute myocardial infarction and recent trials in patients with myocardial infarction (MI) have revealed reduction in deaths in those receiving influenza vaccine. However, all these trials are from temperate countries with definite seasonality of influenza vaccine. The only trial of influenza vaccine outside of temperate regions in heart failure patients was negative. Thus, a trial of influenza vaccine in India, with large number of coronary artery disease patients, is needed to make an informed decision on whether similar benefit would accrue in our patients.
Novelty: No randomised trial on benefits of influenza vaccine in patients of MI available from tropical and developing countries.
Objectives: To assess the impact of influenza vaccine in reducing major adverse cardiovascular events (MACE) in patients with recent MI.
Methods: A total of 3600 patients with recent acute MI (ST elevation and Non-ST elevation MI in previous 12 weeks) will be randomised to receive seasonal inactivated quadrivalent influenza vaccine or placebo saline injection. The primary end point will be reduction in major adverse cardiovascular events (MACE) of all-cause death, non-fatal MI, non-fatal stroke and all-cause hospitalization. The patients will be followed up for a minimum of 12 months.
*Expected outcomes:*The primary outcome will be a composite of all cause death, non-fatal myocardial infarction, non-fatal stroke and all-cause hospitalizations using standardized criteria from time of randomization during the peak influenza season. Secondary outcome will be the composite outcome of all cause death, non-fatal myocardial infarction, non-fatal stroke and all cause hospitalizations during the entire period of the study; Individual components of the composite outcome- all-cause death; cardiovascular death; non-fatal myocardial infarction; non-fatal stroke; all-cause hospitalisation; hospitalisation for heart failure; and pneumonia will be the other secondary outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients > 45 year old with physician diagnosed MI (ST elevation and non ST elevation) in the previous 12 weeks consenting to participate will be randomized to intervention or control arm.
排除标准
- •Anaphylactic reaction to a previous dose of influenza vaccine, 2) IgE-mediated hypersensitivity to egg protein manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock; 3) Guillain-Barré syndrome within eight weeks of a previous influenza vaccine; 4) Anaphylactic reaction to neomycin 5) Influenza vaccine in the previous one year; 6) Plan to be vaccinated with flu vaccine in coming year.
结局指标
主要结局
The primary outcome will be a composite of all cause death, non-fatal myocardial infarction, non-fatal stroke and all-cause hospitalizations using standardized criteria from time of randomization during the peak influenza season.
时间窗: Study Duration will be of four year which include | 6 months for ethical approvals, sites initiation, training. | 6 months of sites close out and data analysis. | Patient will be administered study vaccine or placebo annually with minimum follow up of one year and maximum follow up of 2.5 years.
次要结局
- Secondary outcome will be the composite outcome of all cause death, non-fatal myocardial infarction, non-fatal stroke and all cause hospitalizations during the entire period of the study; Individual components of the composite outcome- all-cause death; cardiovascular death; non-fatal myocardial infarction; non-fatal stroke; all-cause hospitalisation; hospitalisation for heart failure; and pneumonia will be the other secondary outcomes(Study Duration will be of four year which include)
研究者
Dr Ambuj Roy
All India Institute of Medical Sciences, New Delhi