ASPIrin in Reducing Events in Dialysis ( ASPIRED )
- Conditions
- CKD (Chronic Kidney Disease) Stage 5D
- Interventions
- Drug: Matching Placebo
- Registration Number
- NCT04381143
- Lead Sponsor
- Guangdong Provincial People's Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 9000
- Incident or prevalent adults (≥18 years old) dialysis patients are included in the Dialysis Registry.
- An expectation of ongoing maintenance dialysis requirement.
- Willing and able to provide informed consent for this study.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aspirin Aspirin 100 mg Oral Tablet Aspirin tablet 100mg daily Matching Placebo Matching Placebo Placebo tablet 1 pill daily
- Primary Outcome Measures
Name Time Method Number of Participants with composite of major cardiovascular events (3-point MACE) From trial initiation to any event first occurrence, up to 5 years. A composite of cardiovascular death, myocardial infarction, or ischemic stroke.
- Secondary Outcome Measures
Name Time Method Number of Participants with coronary revascularization From trial initiation to any event occurrence, up to 5 years. Number of Participants with fistula or graft thrombosis From trial initiation to any event occurrence, up to 5 years. Number of Participants with haemorrhagic stroke From trial initiation to any event occurrence, up to 5 years. Number of Participants with composite of the primary outcome plus all-cause death From trial initiation to any event first occurrence, up to 5 years. A composite of cardiovascular death, myocardial infarction, ischemic stroke or death.
Number of Participants with composite of major cardiovascular events, hospitalised unstable angina (UA) and hospitalised transient ischaemic attack (TIA) From trial initiation to any event first occurrence, up to 5 years. A composite of cardiovascular death, myocardial infarction, ischemic stroke, hospitalised unstable angina (UA) or hospitalised transient ischaemic attack (TIA)
Number of Participants with cardiovascular death From trial initiation to any event first occurrence, up to 5 years. Death due to CV cause.
Myocardial infarction From trial initiation to any event first occurrence, up to 5 years. Number of Participants with stroke From trial initiation to any event first occurrence, up to 5 years. Number of Participants with all-cause death From trial initiation to any event first occurrence, up to 5 years. Death for any reason.
Number of Participants with ischemic events From trial initiation to any event occurrence, up to 5 years. Defined as a composite of myocardial infarction (MI), coronary death, ischemic stroke, or any revascularization procedure (i.e, exclusion of noncoronary cardiac deaths and strokes confirmed to be haemorrhagic).
Trial Locations
- Locations (110)
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Chaozhou Center Hospital
🇨🇳Chaozhou, Guangdong, China
Dongguan Donghua Hospital
🇨🇳Dongguan, Guangdong, China
Dongguan Eighth People's Hospital
🇨🇳Dongguan, Guangdong, China
Dongguan Marina Bay Center Hospital
🇨🇳Dongguan, Guangdong, China
Dongguan People's Hospital
🇨🇳Dongguan, Guangdong, China
Dongguan Songshan Lake Center Hospital
🇨🇳Dongguan, Guangdong, China
The Second People Hospital of Foshan Nanhai
🇨🇳Foshan, Guangdong, China
Foshan Nanhai District People's Hospital
🇨🇳Foshan, Guangdong, China
Foshan No.1 people's hospital
🇨🇳Foshan, Guangdong, China
Foshan Sanshui District People's Hospital
🇨🇳Foshan, Guangdong, China
Foshan Sanshui People's Hospital
🇨🇳Foshan, Guangdong, China
Foshan Second People's Hospital
🇨🇳Foshan, Guangdong, China
Guangdong Provincial Hospital of Integrative Medicine
🇨🇳Foshan, Guangdong, China
Shunde People's Hospital
🇨🇳Foshan, Guangdong, China
The Third Affiliated Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The first Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital
🇨🇳Guangzhou, Guangdong, China
Guangzhou Redcross Hospital
🇨🇳Guangzhou, Guangdong, China
The first Affiliated Hospital of Jinan University
🇨🇳Guangzhou, Guangdong, China
Guangdong Agricultural Reclamation Central Hospital
🇨🇳Guangzhou, Guangdong, China
Guangdong Cliffod Hospital
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital
🇨🇳Guangzhou, Guangdong, China
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
Hua Du District People's Hospital of Guangzhou
🇨🇳Guangzhou, Guangdong, China
Panyu District people's hospital of Guangzhou
🇨🇳Guangzhou, Guangdong, China
The Fifth Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun yat-sen University
🇨🇳Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
🇨🇳Guanzhou, Guangdong, China
Heyuan People's Hospital
🇨🇳Heyuan, Guangdong, China
Huizhou First People Hospital
🇨🇳Huizhou, Guangdong, China
Huizhou Central People's Hospital
🇨🇳Huizhou, Guangdong, China
Jiangmen Center hospital
🇨🇳Jiangmen, Guangdong, China
Jieyang People's Hospital
🇨🇳Jieyang, Guangdong, China
Kaiping Center Hospital
🇨🇳Kaiping, Guangdong, China
Lianjiang People's Hospital
🇨🇳Lianjiang, Guangdong, China
Lufeng People's Hospital
🇨🇳Lufeng, Guangdong, China
Maoming Hospital of Traditional Chinese Medicine
🇨🇳Maoming, Guangdong, China
Maoming People's Hospital
🇨🇳Maoming, Guangdong, China
Meizhou People's Hospital
🇨🇳Meizhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University Yuedong Hospital
🇨🇳Meizhou, Guangdong, China
Nanxiong People Hospital
🇨🇳Nanxiong, Guangdong, China
Puning People's Hospital
🇨🇳Puning, Guangdong, China
Qingyuan People's Hospital
🇨🇳Qingyuan, Guangdong, China
Fogang People Hospital
🇨🇳Qingyuan, Guangdong, China
Qingyuan Hospital of Traditional Chinese Medicine
🇨🇳Qingyuan, Guangdong, China
The first Affiliated Hospital of Shantou Medical University
🇨🇳Shantou, Guangdong, China
Shantou Chaonan Minsheng Hospital
🇨🇳Shantou, Guangdong, China
Shanwei People's Hospital
🇨🇳Shanwei, Guangdong, China
Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University
🇨🇳Shanwei, Guangdong, China
Wengyuan People Hospital
🇨🇳Shaoguan, Guangdong, China
Shaoguan First People's Hospital
🇨🇳Shaoguan, Guangdong, China
The First People's Hospital of Shaoguan
🇨🇳Shaoguan, Guangdong, China
Yuebei People's Hospital
🇨🇳Shaoguan, Guangdong, China
The Seventh Affiliated Hospital of Sun Yat-sen
🇨🇳Shenzhen, Guangdong, China
Shenzhen Baoan People's Hospital
🇨🇳Shenzhen, Guangdong, China
Shenzhen Hospital of Southern Medical University
🇨🇳Shenzhen, Guangdong, China
Shenzhen Longhua District People's Hospital
🇨🇳Shenzhen, Guangdong, China
Shenzhen No.2 people's hospital
🇨🇳Shenzhen, Guangdong, China
The Eighth Affiliated Hospital of Sun Yat-sen University (Futian, Shenzhen)
🇨🇳Shenzhen, Guangdong, China
ShunDe Hospital Guangzhou University of Chinese Medicine
🇨🇳Shunde, Guangdong, China
Shunde Hospital of Southern Medical University
🇨🇳Shunde, Guangdong, China
Yangjiang Hospital of Traditional Chinese Medicine
🇨🇳Yangjiang, Guangdong, China
Yangjiang People's Hospital
🇨🇳Yangjiang, Guangdong, China
Yunfu People's Hospital
🇨🇳Yunfu, Guangdong, China
The Fourth Affiliated Hospital of Guangzhou Medical University
🇨🇳Zengcheng, Guangdong, China
The Affiliated Hospital of Guangdong Medical University
🇨🇳Zhanjiang, Guangdong, China
Central People's Hospital of Zhanjiang
🇨🇳Zhanjiang, Guangdong, China
Zhaoqing first people's hospital
🇨🇳Zhaoqing, Guangdong, China
Zhongshan City People's Hospital
🇨🇳Zhongshan, Guangdong, China
Zhongshan Traditional Chinese Hospital
🇨🇳Zhongshan, Guangdong, China
Zhongshan Xiaolan People's Hospital
🇨🇳Zhongshan, Guangdong, China
Jinwan Center Hospital of Zhuhai
🇨🇳Zhuhai, Guangdong, China
The fifth affiliated hospital of sun yat-sen university
🇨🇳Zhuhai, Guangdong, China
Zhuhai People's Hospital
🇨🇳Zhuhai, Guangdong, China
The Affiliated Hospital of Youjiang Ethnic Medicine College
🇨🇳Baise, Guangxi, China
The first affiliated hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
People Hospital of Yingde City Guangdong Province
🇨🇳Yingde, Guang, China
Anshun People Hospital
🇨🇳Anshun, Guizhou, China
Guizhou Province Peple's Hospital
🇨🇳Guiyang, Guizhou, China
Hainan Provincial People's Hospital
🇨🇳Haikou, Hainan, China
Xinyang Central Hospital
🇨🇳Xinyang, Henan, China
The Central Hospital of Wuhan
🇨🇳Wuhan, Hubei, China
The Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College of Huazhong Science and Technology University
🇨🇳Wuhan, Hubei, China
Wuhan No.1 People's Hospital
🇨🇳Wuhan, Hubei, China
Yichang central people's hospital
🇨🇳Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
The third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
Ganzhou Municiple Hospital
🇨🇳Ganzhou, Jiangxi, China
Ganzhou People's Hospital
🇨🇳Ganzhou, Jiangxi, China
Jiujiang No.1people's Hospital
🇨🇳Jiujiang, Jiangxi, China
Jiangxi Province Peple's Hospital
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
The First Affiliated Hospital of Air Force Military Medical University
🇨🇳Xi'an, Shanxi, China
Sichuan Province People's Hospital
🇨🇳Chengdu, Sichuan, China
The First People's Hospital of Kashi Prefecture
🇨🇳Kashi, Xinjiang, China
The First Affiliated Hospital of Shihezi University Medical College
🇨🇳Shihezi, Xinjiang, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang, China
The People's hospital of Xinjiang Uygur Autonomous Region
🇨🇳Ürümqi, Xinjiang, China
Fengqing People's Hospital of Yunnan Province
🇨🇳Lincang, Yunnan, China
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China