Clinical trial NCT04381143: ASPIrin in Reducing Events in Dialysis ( ASPIRED )
Official title: ASPIrin in Reducing Events in Dialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: CKD (Chronic Kidney Disease) Stage 5D
Keywords: Aspirin
Dialysis
End Stage Kidney Disease
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: The George Institute
First posted: 2020-05-08
Enrollment: 9000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic designs
Primary purpose: TREATMENT

Brief summary: People with kidney failure requiring dialysis have a much higher risk of developing cardiovascular (CV) disease compared with the general population. A cardiac cause accounts for 58% of all deaths in patients with end stage kidney disease (ESKD). At the same time, this population has increased risks of clotting as well as bleeding episodes. While aspirin is known to reduce cardiovascular complications in the general population, evidence to support the use of aspirin in people with ESKD receiving dialysis therapy is currently lacking. The ASPIrin to Reduce Event in Dialysis (ASPIRED) trial will test whether aspirin use in dialysis patients safely improves outcomes compared with no aspirin use.

Detailed description: ASPIRED is an investigator-initiated, multi-center, double-blind, parallel group, event-driven, pragmatic, registry-based randomized controlled trial that will define the value of low dose aspirin (100 mg daily) on cardiovascular events in people with ESKD receiving dialysis.

The study will be conducted using the existing platform of the Chinese peritoneal dialysis (PD) and hemodialysis (HD) Dialysis Registry to screen, recruit and to collect study data as part of patient's routine clinical care during dialysis to improve efficiency and to minimize cost of a clinical trial.

ASPIRED is an event driven trial with an anticipated duration of approximately 5 years.

Randomization will be performed using a web-based system via a pass word protected encrypted website interface.

The study procedure utilizes routine six-monthly clinic visits for study follow-up to increase efficiency and minimize the burden on participants.

The analysis will be based on intention-to-treat principles. An independent Data Safety and Monitoring Board (DSMB) will established to monitor the study for safety and efficacy.

Eligibility criteria: Inclusion Criteria:

* Incident or prevalent adults (≥18 years old) dialysis patients are included in the Dialysis Registry.
* Commenced on dialysis with the expectation of ongoing maintenance dialysis requirement.
* Willing and able to provide informed consent for this study.

Exclusion Criteria:

* Requirement for any form of antiplatelet agent (aspirin, glycoprotein IIb/IIIa inhibitors etc), or oral anticoagulation (warfarin, NOACs), in the view of the treating physician.
* Contraindication to aspirin, in the view of the treating physician.
* Dialysis requirement due to acute kidney injure with expectation of kidney function recovery.
* History of haemorrhagic stroke or intracranial bleed within 12 months of screening.
* Coagulopathy from any cause.
* Unable to provide informed consent.

Primary outcomes:
measure: Number of Participants with composite of major cardiovascular events (3-point MACE)
timeFrame: From trial initiation to any event first occurrence, up to 5 years.
Secondary outcomes:
measure: Number of Participants with composite of major cardiovascular events plus all-cause death
timeFrame: From trial initiation to any event first occurrence, up to 5 years.
measure: Number of Participants with composite of major cardiovascular events, hospitalised unstable angina (UA) and hospitalised transient ischaemic attack (TIA)
timeFrame: From trial initiation to any event first occurrence, up to 5 years.
measure: Number of Participants with cardiovascular death
timeFrame: From trial initiation to any event first occurrence, up to 5 years.
measure: Number of Participants with Myocardial infarction
timeFrame: From trial initiation to any event first occurrence, up to 5 years.
measure: Number of Participants with ischemic stroke
timeFrame: From trial initiation to any event first occurrence, up to 5 years.
measure: Number of Participants with all-cause death
timeFrame: From trial initiation to any event first occurrence, up to 5 years.
measure: Number of Participants with coronary revascularization
timeFrame: From trial initiation to any event occurrence, up to 5 years.
measure: Number of Participants with fistula or graft thrombosis
timeFrame: From trial initiation to any event occurrence, up to 5 years.
measure: Number of Participants with intracranial haemorrhage
timeFrame: From trial initiation to any event occurrence, up to 5 years.
measure: Number of Participants with peripheral vascular events
timeFrame: From trial initiation to any event occurrence, up to 5 years.
measure: Number of Participants with ischemic events
timeFrame: From trial initiation to any event occurrence, up to 5 years.
Other outcomes:
measure: Major bleeding
timeFrame: From trial initiation to any event first occurrence, up to 5 years.
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Longyan
country: China
facility: Shanghang County Hospital
state: Fujian
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Dongguan
country: China
facility: Dongguan Donghua Hospital
state: Guangdong
city: Dongguan
country: China
facility: Dongguan Hospital of Integrative Traditional Chinese and Western Medicine
state: Guangdong
city: Dongguan
country: China
facility: Dongguan Eighth People's Hospital
state: Guangdong
city: Dongguan
country: China
facility: Dongguan Marina Bay Center Hospital
state: Guangdong
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Dongguan
country: China
facility: Dongguan Songshan Lake Center Hospital
state: Guangdong
city: Foshan
country: China
facility: Foshan Gaoming District People's Hospital
state: Guangdong
city: Foshan
country: China
facility: The Second People Hospital of Foshan Nanhai
state: Guangdong
city: Foshan
country: China
facility: Foshan Nanhai District People's Hospital
state: Guangdong
city: Foshan
country: China
facility: Foshan No.1 people's hospital
state: Guangdong
city: Foshan
country: China
facility: Foshan Sanshui People's Hospital
state: Guangdong
city: Foshan
country: China
facility: Foshan Second People's Hospital
state: Guangdong
city: Foshan
country: China
facility: Guangdong Provincial Hospital of Integrative Medicine
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Redcross Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine Fangcun Branch (Guangzhou Charity Hospital)
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Agricultural Reclamation Central Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Cliffod Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Peoples Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Hua Du District People's Hospital of Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: Panyu District people's hospital of Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guanzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Heyuan
country: China
facility: Heyuan People's Hospital
state: Guangdong
city: Huizhou
country: China
facility: Huizhou First People Hospital
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Central People's Hospital
state: Guangdong
city: Jiangmen
country: China
facility: The People's Hospital of Jiangmen
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Center hospital
state: Guangdong
city: Jieyang
country: China
facility: Jieyang People's Hospital
state: Guangdong
city: Kaiping
country: China
facility: Kaiping Center Hospital
state: Guangdong
city: Lianjiang
country: China
facility: Lianjiang People's Hospital
state: Guangdong
city: Lufeng
country: China
facility: Lufeng People's Hospital
state: Guangdong
city: Maoming
country: China
facility: Maoming Hospital of Traditional Chinese Medicine
state: Guangdong
city: Maoming
country: China
facility: Maoming People's Hospital
state: Guangdong
city: Meizhou
country: China
facility: Meizhou People's Hospital
state: Guangdong
city: Meizhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University Yuedong Hospital
state: Guangdong
city: Nanxiong
country: China
facility: Nanxiong People Hospital
state: Guangdong
city: Puning
country: China
facility: Puning People's Hospital
state: Guangdong
city: Qingyuan
country: China
facility: Qingyuan People's Hospital
state: Guangdong
city: Qingyuan
country: China
facility: Fogang People Hospital
state: Guangdong
city: Qingyuan
country: China
facility: Qingyuan Hospital of Traditional Chinese Medicine
state: Guangdong
city: Shantou
country: China
facility: The Second Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Shantou
country: China
facility: The first Affiliated Hospital of Shantou Medical University
state: Guangdong
city: Shantou
country: China
facility: Shantou Chaonan Minsheng Hospital
state: Guangdong
city: Shanwei
country: China
facility: Shanwei People's Hospital
state: Guangdong
city: Shanwei
country: China
facility: Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University
state: Guangdong
city: Shaoguan
country: China
facility: Wengyuan People Hospital
state: Guangdong
city: Shaoguan
country: China
facility: Shaoguan First People's Hospital
state: Guangdong
city: Shaoguan
country: China
facility: The First People's Hospital of Shaoguan
state: Guangdong
city: Shaoguan
country: China
facility: Yuebei People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The Seventh Affiliated Hospital of Sun Yat-sen
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Baoan People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Hospital of Southern Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Longhua District People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen No.2 people's hospital
state: Guangdong
city: Shenzhen
country: China
facility: The Eighth Affiliated Hospital of Sun Yat-sen University (Futian, Shenzhen)
state: Guangdong
city: Shunde
country: China
facility: ShunDe Hospital Guangzhou University of Chinese Medicine
state: Guangdong
city: Shunde
country: China
facility: The Eighth Affiliated Hospital of Southern Medical University, The First People's Hospital of Shunde
state: Guangdong
city: Yangjiang
country: China
facility: People's Hospital of Yangdong District Yangjiang City
state: Guangdong
city: Yangjiang
country: China
facility: Yangjiang Hospital of Traditional Chinese Medicine
state: Guangdong
city: Yangjiang
country: China
facility: Yangjiang People's Hospital
state: Guangdong
city: Yingde
country: China
facility: People Hospital of Yingde City Guangdong Province
state: Guangdong
city: Yunfu
country: China
facility: Yunfu People's Hospital
state: Guangdong
city: Zengcheng
country: China
facility: The Fourth Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Zhanjiang
country: China
facility: The Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Zhanjiang
country: China
facility: Central People's Hospital of Zhanjiang
state: Guangdong
city: Zhaoqing
country: China
facility: Zhaoqing first people's hospital
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan City People's Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan Traditional Chinese Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan Xiaolan People's Hospital
state: Guangdong
city: Zhuhai
country: China
facility: Jinwan Center Hospital of Zhuhai
state: Guangdong
city: Zhuhai
country: China
facility: The fifth affiliated hospital of sun yat-sen university
state: Guangdong
city: Zhuhai
country: China
facility: Zhuhai People's Hospital
state: Guangdong
city: Shantou
country: China
facility: Shantou Central Hospital
state: Guanggong
city: Baise
country: China
facility: The Affiliated Hospital of Youjiang Ethnic Medicine College
state: Guangxi
city: Nanning
country: China
facility: The first affiliated hospital of Guangxi Medical University
state: Guangxi
city: Anshun
country: China
facility: China Guihang 302 Hospital
state: Guizhou
city: Anshun
country: China
facility: Anshun People Hospital
state: Guizhou
city: Guiyang
country: China
facility: Guizhou Province Peple's Hospital
state: Guizhou
city: Haikou
country: China
facility: The First Affiliated Hospital of Hainan Medical University
state: Hainan
city: Haikou
country: China
facility: Hainan Provincial People's Hospital
state: Hainan
city: Xinyang
country: China
facility: Xinyang Central Hospital
state: Henan
city: Huangshi
country: China
facility: Huangshi Central Hospital
state: Hubei
city: Jingmen
country: China
facility: Jingmen Central Hospital
state: Hubei
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: The Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of Huazhong Science and Technology University
state: Hubei
city: Wuhan
country: China
facility: Wuhan No.1 People's Hospital
state: Hubei
city: Wuhan
country: China
facility: Yichang central people's hospital
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Changsha
country: China
facility: The third Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Nantong
country: China
facility: Nantong Haimen People's Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Mining Group General Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Subei People's Hospital
state: Jiangsu
city: Ganzhou
country: China
facility: Ganzhou Municiple Hospital
state: Jiangxi
city: Ganzhou
country: China
facility: Ganzhou People's Hospital
state: Jiangxi
city: Jiujiang
country: China
facility: Jiujiang No.1people's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Province Peple's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Air Force Military Medical University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Province People's Hospital
state: Sichuan
city: Kashi
country: China
facility: Jiashi County People's Hospital
state: Xinjiang
city: Kashi
country: China
facility: Shache County People's Hospital
state: Xinjiang
city: Kashi
country: China
facility: The First People's Hospital of Kashi Prefecture
state: Xinjiang
city: Kashi
country: China
facility: The Second People's Hospital of Kashi Prefecture
state: Xinjiang
city: Shihezi
country: China
facility: The First Affiliated Hospital of Shihezi University Medical College
state: Xinjiang
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Ürümqi
country: China
facility: The People's hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Lincang
country: China
facility: Fengqing People's Hospital of Yunnan Province
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Lishui
country: China
facility: Lishui City Center Hospital
state: Zhejiang
city: Zhoushan
country: China
facility: Zhoushan Hospital
state: Zhejiang
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Xueqing Yu
role: STUDY_CHAIR
affiliation: The University of New South Wales Sydney
name: Vlado Perkovic
role: STUDY_CHAIR
affiliation: The George Institute
name: Muh Geot Wong
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Wei Chen
role: STUDY_DIRECTOR
affiliation: Guangdong Provincial People's Hospital
name: Li Fan
role: STUDY_DIRECTOR
affiliation: Guangdong Provincial People's Hospital
name: Zhiming Ye
role: STUDY_DIRECTOR
References: