Predischarge Bundle for Patients in Dual Antiplatelet Therapy to Minimize the Negative Impact of Nuisance Bleedings on Quality of Life: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 448
- 试验地点
- 2
- 主要终点
- quality of life
研究概览
简要总结
A single-center, randomized trial of admitted patients with ischemic heart disease receiving percutaneous coronary intervention and stent implantation will be conducted at University Hospital of Ferrara. Patients will be randomized to either the control (standard care) or the bundle group in which patients will receive counseling regarding dual antiplatelet therapy management, advantages and side effects, screening for depression or anxiety, standardized education. The primary endpoint will be the difference in the quality of life as assessed by EQ-5D questionnaire.
详细描述
Recent studies suggest that bleeding complications have a strong influence on quality of life. During DAPT regimen bleeding complications occur from 5% to 15% of patients. Nuisance bleedings (BARC 1 bleeding) occur more frequently and show a strong influence on quality of life, depression, anxiety and compliance to the treatment.
The aim of the study is to establish if a specific counseling programme might minimize the negative quality of life impact of nuisance bleedings. A computer-generated list will be used to randomize patients in a 1:1 ratio, stratified by age, sex, renal failure and P2Y12 inhibitor, to either the bundle or the control group.
All patients randomized to the control group (standard of care) will receive education from physician regarding dual antiplatelet therapy (DAPT) as part of the routine discharge process.
All patients randomized to the bundle group will receive:
i) a 15-min visit by a member of the research team 24 h prior to the anticipated discharge day. During this visit, a core set of DAPT risks will be addressed. Advantages and side effects of DAPT will be described. The importance of compliance will be discussed. The correct management of side effects (especially BARC 1 bleedings) will be discussed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •signed written informed consent
- •hospital admission for ischemic heart disease with clinical indication to coronary artery angiography
- •percutaneous coronary intervention and drug eluting stent implantation
- •indication to dual antiplatelet therapy for at least 6 months
排除标准
- •oral anticoagulant therapy
- •bleeding event in the 30 days before the enrolment
- •planned surgery
研究组 & 干预措施
good clinical practice
all patients will receive education from physician regarding management of dual antiplatelet therapy as part of the routine discharge process
干预措施: good clinical practice (Behavioral)
bundle group
patients assigned to the bundle group will receive visits and materials as described by the protocol (counseling)
干预措施: bundle group (Behavioral)
结局指标
主要结局
quality of life
时间窗: 1 month
quality of life assessment in each patient by EQ-5D questionnaire
次要结局
- bleeding academic research consortium (BARC) 2-3(1 month)
- bleeding academic research consortium (BARC) 1(1 month)
- emergency room admission(1 month)
- general practitioner visit(1 month)
- dyspnea occurrence(1 month)
研究者
Gianluca Campo
interventional cardiologist and assistant professor
University Hospital of Ferrara