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ASPIrin in Reducing Events in Dialysis ( ASPIRED )

Sponsor
Guangdong Provincial People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04381143
Collaborator
George Clinical Pty Ltd (Industry)
9,000
Enrollment
67
Locations
2
Arms
71
Anticipated Duration (Months)
134.3
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Aspirin 100 mg Oral Tablet
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
9000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Pragmatic designsPragmatic designs
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
ASPIrin in Reducing Events in Dialysis
Actual Study Start Date :
Jul 30, 2020
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Aspirin

Aspirin tablet 100mg daily

Drug: Aspirin 100 mg Oral Tablet
Aspirin 100 mg tablets daily
Placebo Comparator: Matching Placebo

Placebo tablet 1 pill daily

Drug: Aspirin 100 mg Oral Tablet
Aspirin 100 mg tablets daily

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.]

  3. Number of Participants with cardiovascular death [From trial initiation to any event first occurrence, up to 5 years.]

  4. Myocardial infarction [From trial initiation to any event first occurrence, up to 5 years.]

  5. Number of Participants with stroke [From trial initiation to any event first occurrence, up to 5 years.]

  6. Number of Participants with all-cause death [From trial initiation to any event first occurrence, up to 5 years.]

    Death for any reason.

  7. Number of Participants with coronary revascularization [From trial initiation to any event occurrence, up to 5 years.]

  8. Number of Participants with fistula or graft thrombosis [From trial initiation to any event occurrence, up to 5 years.]

  9. Number of Participants with haemorrhagic stroke [From trial initiation to any event occurrence, up to 5 years.]

  10. 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).

Other Outcome Measures

  1. Major bleeding [From trial initiation to any event first occurrence, up to 5 years.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Adult patients who are entered into the Chinese PD and HD dialysis registry

  • Expected requirement for ongoing maintenance dialysis

  • Willing and able to provide informed consent

Exclusion Criteria:

  • Requirement of antiplatelet agent or oral anticoagulation, in the view of the treating physician

  • Contraindication to aspirin

  • Dialysis requirement due to acute kidney injure I with the expectation of kidney function recovery

  • History of haemorrhagic stroke or intracranial bleed within the past 12 months

  • Coagulopathy from any cause

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian China
2 The First Hospital of Lanzhou University Lanzhou Gansu China
3 Chaozhou Center Hospital Chaozhou Guangdong China
4 Dongguan People's Hospital Dongguan Guangdong China
5 Foshan Nanhai District People's Hospital Foshan Guangdong China
6 Foshan No.1 people's hospital Foshan Guangdong China
7 Foshan Sanshui District People's Hospital Foshan Guangdong China
8 Foshan Second People's Hospital Foshan Guangdong China
9 Shunde People's Hospital Foshan Guangdong China
10 Guangdong Agricultural Reclamation Central Hospital Guangzhou Guangdong China
11 Guangdong Provincial Peoples Hospital Guangzhou Guangdong China
12 Guangzhou First People's Hospital Guangzhou Guangdong China
13 Hua Du District People's Hospital of Guangzhou Guangzhou Guangdong China
14 Panyu District people's hospital of Guangzhou Guangzhou Guangdong China
15 The Sixth Affiliated Hospital of Sun yat-sen University Guangzhou Guangdong China
16 The Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong China
17 The First Affiliated Hospital of Sun Yat-sen University Guanzhou Guangdong China
18 Heyuan People's Hospital Heyuan Guangdong China
19 Jiangmen Center hospital Jiangmen Guangdong China
20 Kaiping Center Hospital Kaiping Guangdong China
21 Lianjiang People's Hospital Lianjiang Guangdong China
22 Maoming People's Hospital Maoming Guangdong China
23 Shanwei People's Hospita Shanwei Guangdong China
24 The First People's Hospital of Shaoguan Shaoguan Guangdong China
25 Shenzhen Baoan People's Hospital Shenzhen Guangdong China
26 Shenzhen No.2 people's hospital Shenzhen Guangdong China
27 Yangjiang People's Hospital Yangjiang Guangdong China
28 Yunfu People's Hospital Yunfu Guangdong China
29 Central People's Hospital of Zhanjiang Zhanjiang Guangdong China
30 Zhaoqing first people's hospital Zhaoqing Guangdong China
31 Zhongshan City People's Hospital Zhongshan Guangdong China
32 Zhongshan People's Hospital Zhongshan Guangdong China
33 Zhongshan Traditional Chinese Hospital Zhongshan Guangdong China
34 The fifth affiliated hospital of sun yat-sen university Zhuhai Guangdong China
35 The Affiliated Hospital of Youjiang Ethnic Medicine College Baise Guangxi China
36 The first affiliated hospital of Guangxi Medical University Nanning Guangxi China
37 Guizhou Province Peple's Hospital Guiyang Guizhou China
38 Guizhou Provincial People's Hospital Guiyang Guizhou China
39 Hainan Provincial People's Hospital Haikou Hainan China
40 Xinyang Central Hospital Xinyang Henan China
41 The Central Hospital of Wuhan Wuhan Hubei China
42 The Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei China
43 Tongji Hospital, Tongji Medical College of Huazhong Science and Technology University Wuhan Hubei China
44 Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China
45 Union Hospital of Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei China
46 Wuhan First People's Hospital Wuhan Hubei China
47 Wuhan No.1 People's Hospital Wuhan Hubei China
48 Yichang central people's hospital Wuhan Hubei China
49 Zhongnan Hospital of Wuhan University Wuhan Hubei China
50 The third Xiangya Hospital of Central South University Changsha Hunan China
51 Xiangya Hospital Central South University Changsha Hunan China
52 Hunan Provincial People's Hospital Shangsha Hunan China
53 The Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia China
54 Ganzhou People's Hospital Ganzhou Jiangxi China
55 Jiujiang No.1people's Hospital Jiujiang Jiangxi China
56 Jiangxi Province Peple's Hospital Nanchang Jiangxi China
57 The First Affiliated Hospital of Nanchang University Nanchang Jiangxi China
58 General Hospital of Ningxia Medical University Yinchuan Ningxia China
59 The Affiliated Hospital of Qingdao University Qingdao Shandong China
60 The First Affiliated Hospital of Air Force Military Medical University Xi'an Shanxi China
61 Sichuan Province People's Hospital Chengdu Sichuan China
62 The First People's Hospital of Kashi Prefecture Kashi Xinjiang China
63 The First Affiliated Hospital of Shihezi University Medical College Shihezi Xinjiang China
64 The First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang China
65 The People's hospital of Xinjiang Uygur Autonomous Region Ürümqi Xinjiang China
66 Fengqing People's Hospital of Yunnan Province Lincang Yunnan China
67 The First Affiliated Hospital, Zhejiang University Hangzhou Zhejiang China

Sponsors and Collaborators

  • Guangdong Provincial People's Hospital
  • George Clinical Pty Ltd

Investigators

  • Study Chair: Xueqing Yu, Guangdong Provincial People's Hospital
  • Study Chair: Vlado Perkovic, The George Institute
  • Study Director: Muh Geot Wong, The George Institute
  • Study Director: Wei Chen, First Affiliated Hospital, Sun Yat-Sen University
  • Study Director: Li Fan, First Affiliated Hospital, Sun Yat-Sen University
  • Study Director: Zhiming Ye, Guangdong Provincial People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier:
NCT04381143
Other Study ID Numbers:
  • GDPH-CH-2774
First Posted:
May 8, 2020
Last Update Posted:
Jan 24, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Guangdong Provincial People's Hospital
Aspirin
Dialysis
End Stage Kidney Disease
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Aspirin

Study Results

No Results Posted as of Jan 24, 2022