ASPIrin in Reducing Events in Dialysis ( ASPIRED )

CKD (Chronic Kidney Disease) Stage 5D Clinical Trial

Official title:

ASPIrin in Reducing Events in Dialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04381143
• Other study ID #: GDPH-CH-2774
• Status: Recruiting
• Phase: Phase 4
• Start date: July 30, 2020
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Guangdong Provincial People's Hospital
• Contact: Xueqing Yu
• Phone: +86-20-83827812
• Email: yuxueqing[@]gdph.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 9000
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

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.

Related Conditions & MeSH terms

• CKD (Chronic Kidney Disease) Stage 5D
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Aspirin 100 mg Oral Tablet
Aspirin 100 mg tablet daily
• Matching Placebo
Matching Placebo 1 pill daily

Locations

Country	Name	City	State
China	Anshun People Hospital	Anshun	Guizhou
China	The Affiliated Hospital of Youjiang Ethnic Medicine College	Baise	Guangxi
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	Chaozhou Center Hospital	Chaozhou	Guangdong
China	Sichuan Province People's Hospital	Chengdu	Sichuan
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	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 Second People Hospital of Foshan Nanhai	Foshan	Guangdong
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Ganzhou Municiple Hospital	Ganzhou	Jiangxi
China	Ganzhou People's Hospital	Ganzhou	Jiangxi
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	Guangzhou Redcross 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	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong
China	The Fifth Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The first Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou University of Chinese Medicine	Guangzhou	Guangdong
China	The first Affiliated Hospital of Jinan University	Guangzhou	Guangdong
China	The Sixth Affiliated Hospital of Sun yat-sen University	Guangzhou	Guangdong
China	The Third Affiliated Hospital of Southern Medical 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	Guizhou Province Peple's Hospital	Guiyang	Guizhou
China	Hainan Provincial People's Hospital	Haikou	Hainan
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Heyuan People's Hospital	Heyuan	Guangdong
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	Huizhou Central People's Hospital	Huizhou	Guangdong
China	Huizhou First People Hospital	Huizhou	Guangdong
China	Jiangmen Center hospital	Jiangmen	Guangdong
China	Jieyang People's Hospital	Jieyang	Guangdong
China	Jiujiang No.1people's Hospital	Jiujiang	Jiangxi
China	Kaiping Center Hospital	Kaiping	Guangdong
China	The First People's Hospital of Kashi Prefecture	Kashi	Xinjiang
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Lianjiang People's Hospital	Lianjiang	Guangdong
China	Fengqing People's Hospital of Yunnan Province	Lincang	Yunnan
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	Jiangxi Province Peple's Hospital	Nanchang	Jiangxi
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The first affiliated hospital of Guangxi Medical University	Nanning	Guangxi
China	Nanxiong People Hospital	Nanxiong	Guangdong
China	Puning People's Hospital	Puning	Guangdong
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Fogang People Hospital	Qingyuan	Guangdong
China	Qingyuan Hospital of Traditional Chinese Medicine	Qingyuan	Guangdong
China	Qingyuan People's Hospital	Qingyuan	Guangdong
China	Shantou Chaonan Minsheng Hospital	Shantou	Guangdong
China	The first Affiliated Hospital of Shantou Medical University	Shantou	Guangdong
China	Shanwei People's Hospital	Shanwei	Guangdong
China	Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University	Shanwei	Guangdong
China	Shaoguan First People's Hospital	Shaoguan	Guangdong
China	The First People's Hospital of Shaoguan	Shaoguan	Guangdong
China	Wengyuan People Hospital	Shaoguan	Guangdong
China	Yuebei People's Hospital	Shaoguan	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	The Seventh Affiliated Hospital of Sun Yat-sen	Shenzhen	Guangdong
China	The First Affiliated Hospital of Shihezi University Medical College	Shihezi	Xinjiang
China	ShunDe Hospital Guangzhou University of Chinese Medicine	Shunde	Guangdong
China	Shunde Hospital of Southern Medical University	Shunde	Guangdong
China	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	The People's hospital of Xinjiang Uygur Autonomous Region	Ürümqi	Xinjiang
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	The First Affiliated Hospital of Air Force Military Medical University	Xi'an	Shanxi
China	Xinyang Central Hospital	Xinyang	Henan
China	Yangjiang Hospital of Traditional Chinese Medicine	Yangjiang	Guangdong
China	Yangjiang People's Hospital	Yangjiang	Guangdong
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	People Hospital of Yingde City Guangdong Province	Yingde	Guang
China	Yunfu People's Hospital	Yunfu	Guangdong
China	The Fourth Affiliated Hospital of Guangzhou Medical University	Zengcheng	Guangdong
China	Central People's Hospital of Zhanjiang	Zhanjiang	Guangdong
China	The Affiliated Hospital of Guangdong Medical University	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

Sponsors (2)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital	The George Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major bleeding	Major bleeding is defined based on modified International Society on Thrombosis and Haemostasis (ISTH) definition, including fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intra-spinal, intra-ocular, retro-peritoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, or bleeding into a surgical site requiring re-operation, and/or bleeding leading to hospitalization.	From trial initiation to any event first occurrence, up to 5 years.
Primary	Number of Participants with composite of major cardiovascular events (3-point MACE)	A composite of cardiovascular death, myocardial infarction, or ischemic stroke.	From trial initiation to any event first occurrence, up to 5 years.
Secondary	Number of Participants with composite of the primary outcome plus all-cause death	A composite of cardiovascular death, myocardial infarction, ischemic stroke or death.	From trial initiation to any event first occurrence, up to 5 years.
Secondary	Number of Participants with composite of major cardiovascular events, hospitalised unstable angina (UA) and hospitalised transient ischaemic attack (TIA)	A composite of cardiovascular death, myocardial infarction, ischemic stroke, hospitalised unstable angina (UA) or hospitalised transient ischaemic attack (TIA)	From trial initiation to any event first occurrence, up to 5 years.
Secondary	Number of Participants with cardiovascular death	Death due to CV cause.	From trial initiation to any event first occurrence, up to 5 years.
Secondary	Myocardial infarction		From trial initiation to any event first occurrence, up to 5 years.
Secondary	Number of Participants with stroke		From trial initiation to any event first occurrence, up to 5 years.
Secondary	Number of Participants with all-cause death	Death for any reason.	From trial initiation to any event first occurrence, up to 5 years.
Secondary	Number of Participants with coronary revascularization		From trial initiation to any event occurrence, up to 5 years.
Secondary	Number of Participants with fistula or graft thrombosis		From trial initiation to any event occurrence, up to 5 years.
Secondary	Number of Participants with haemorrhagic stroke		From trial initiation to any event occurrence, up to 5 years.
Secondary	Number of Participants with ischemic events	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).	From trial initiation to any event occurrence, up to 5 years.