PDF(Pubmed)
Abstract：
UNASSIGNED: Although aspirin can effectively reduce the occurrence of atherothrombosis, it is significantly associated with increased bleeding, with elderly individuals being at increased risk of cardiovascular diseases(CVDs) and hemorrhage. While the adverse effects of aspirin can be reduced by using the lowest effective dose, its optimal dose remains undetermined in the elderly Chinese population with both higher cardiovascular and bleeding risks. This study aims to assess the current status of aspirin therapy in real-world clinical settings as well as investigate the efficacy and safety of different doses of aspirin intake (≤ 50 mg/d and > 50 mg/d) for CVD prevention and management in elderly Chinese individuals.
UNASSIGNED: The Low-dose Aspirin for Primary and Secondary Prevention of Cardiovascular Disease in the Elderly Study (LAPIS) is a multicenter, prospective, observational cohort study. At least 10,000 people aged ≥ 60 years who require long-term aspirin therapy will be recruited. The effectiveness outcome is a composite of major cardiovascular events(MACEs), including nonfatal myocardial infarction, unstable angina, arteriosclerotic disease requiring surgery or intervention, nonfatal stroke, transient ischemic attack, or cardiovascular death (excluding intracranial hemorrhage). The safety outcome is a composite of the first occurrence of fatal bleeding, major bleeding and minor bleeding. Information on the incidence of aspirin-associated gastrointestinal adverse events will also be collected for safety analyses. Outcome measurements will be performed at intervals of 30 days, 3 months, 6 months and then every 6 months for the next 3 years.
UNASSIGNED: The results of the LAPIS study will ascertain the efficacy and safety of different doses of aspirin for the prevention and management of CVD, thereby providing evidence to determine the optimal evidence-based dose of aspirin therapy in Chinese elderly individuals.
UNASSIGNED: ChiCTR1900021980 (chictr.org.cn). Registered on March 19, 2019.
UNASSIGNED: The Low-dose Aspirin for Primary and Secondary Prevention of Cardiovascular Disease in the Elderly Study (LAPIS) is a multicenter, prospective, observational cohort study. At least 10,000 people aged ≥ 60 years who require long-term aspirin therapy will be recruited. The effectiveness outcome is a composite of major cardiovascular events(MACEs), including nonfatal myocardial infarction, unstable angina, arteriosclerotic disease requiring surgery or intervention, nonfatal stroke, transient ischemic attack, or cardiovascular death (excluding intracranial hemorrhage). The safety outcome is a composite of the first occurrence of fatal bleeding, major bleeding and minor bleeding. Information on the incidence of aspirin-associated gastrointestinal adverse events will also be collected for safety analyses. Outcome measurements will be performed at intervals of 30 days, 3 months, 6 months and then every 6 months for the next 3 years.
UNASSIGNED: The results of the LAPIS study will ascertain the efficacy and safety of different doses of aspirin for the prevention and management of CVD, thereby providing evidence to determine the optimal evidence-based dose of aspirin therapy in Chinese elderly individuals.
UNASSIGNED: ChiCTR1900021980 (chictr.org.cn). Registered on March 19, 2019.
摘要：
UASSIGNED：尽管阿司匹林可以有效减少动脉粥样硬化的发生，它与出血增加显著相关，老年人患心血管疾病（CVD）和出血的风险增加。虽然使用最低有效剂量可以减少阿司匹林的不良反应，在心血管疾病和出血风险均较高的中国老年人群中,其最佳剂量仍未确定.本研究旨在评估真实世界临床环境中阿司匹林治疗的现状，并探讨不同剂量阿司匹林摄入（≤50mg/d和>50mg/d）对中国老年人心血管疾病预防和管理的有效性和安全性。
UNASSIGNED：低剂量阿司匹林用于老年人心血管疾病一级和二级预防的研究（LAPIS）是一个多中心，prospective,观察性队列研究。将招募至少10,000名年龄≥60岁的需要长期阿司匹林治疗的人。有效性结果是主要心血管事件(MACE)的复合，包括非致死性心肌梗死,不稳定型心绞痛,动脉硬化疾病需要手术或干预，非致命性中风,短暂性脑缺血发作,或心血管死亡（不包括颅内出血）。安全性结果是首次发生致命出血的复合结果，大出血和小出血。有关阿司匹林相关胃肠道不良事件发生率的信息也将被收集用于安全性分析。结果测量将以30天的间隔进行，3个月,6个月，然后在接下来的3年内每6个月。
UNASSIGNED：LAPIS研究的结果将确定不同剂量的阿司匹林预防和治疗CVD的疗效和安全性，从而为确定中国老年人阿司匹林治疗的最佳循证剂量提供证据。
未经批准：ChiCTR1900021980(chictr.org.cn)。2019年3月19日注册。
UNASSIGNED：低剂量阿司匹林用于老年人心血管疾病一级和二级预防的研究（LAPIS）是一个多中心，prospective,观察性队列研究。将招募至少10,000名年龄≥60岁的需要长期阿司匹林治疗的人。有效性结果是主要心血管事件(MACE)的复合，包括非致死性心肌梗死,不稳定型心绞痛,动脉硬化疾病需要手术或干预，非致命性中风,短暂性脑缺血发作,或心血管死亡（不包括颅内出血）。安全性结果是首次发生致命出血的复合结果，大出血和小出血。有关阿司匹林相关胃肠道不良事件发生率的信息也将被收集用于安全性分析。结果测量将以30天的间隔进行，3个月,6个月，然后在接下来的3年内每6个月。
UNASSIGNED：LAPIS研究的结果将确定不同剂量的阿司匹林预防和治疗CVD的疗效和安全性，从而为确定中国老年人阿司匹林治疗的最佳循证剂量提供证据。
未经批准：ChiCTR1900021980(chictr.org.cn)。2019年3月19日注册。
