ASPIrin in Reducing Events in Dialysis ( ASPIRED )

ASPIrin in Reducing Events in Dialysis

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.

Study Overview

• Status: Recruiting
• Conditions: CKD (Chronic Kidney Disease) Stage 5D
• Intervention / Treatment: Drug: Aspirin 100 mg Oral Tablet; Drug: Matching Placebo

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 Type: Interventional
• Enrollment (Estimated): 9000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xueqing Yu; Phone Number: +86-20-83827812; Email: yuxueqing@gdph.org.cn
• Study Contact Backup: Name: Li Fan; Phone Number: +86-20-87755766-8174; Email: fanli@gdph.org.cn

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • The First Affiliated Hospital Of Fujian Medical University
      • Contact: Jianxin Wan
  • Gansu
    • Lanzhou, Gansu, China
      • Recruiting
      • The First Hospital of Lanzhou University
      • Contact: Tianxi Liu
  • Guang
    • Yingde, Guang, China
      • Recruiting
      • People Hospital of Yingde City Guangdong Province
      • Contact: Chifeng Wang
  • Guangdong
    • Chaozhou, Guangdong, China
      • Withdrawn
      • Chaozhou Center Hospital
    • Dongguan, Guangdong, China
      • Recruiting
      • Dongguan People's Hospital
      • Contact: Guohui Liu
      • Sub-Investigator: Yi Li
    • Dongguan, Guangdong, China, 523413
      • Recruiting
      • Dongguan Donghua Hospital
      • Contact: Xiaoyan Su
      • Principal Investigator: Xiaoyan Su
    • Dongguan, Guangdong, China
      • Recruiting
      • Dongguan Eighth People's Hospital
      • Contact: Zhixiong Lin
    • Dongguan, Guangdong, China
      • Recruiting
      • Dongguan Marina Bay Center Hospital
      • Contact: Houqin Xiao
    • Dongguan, Guangdong, China
      • Not yet recruiting
      • Dongguan Songshan Lake Center Hospital
      • Contact: Huaqin Zhuo
    • Foshan, Guangdong, China, 528251
      • Not yet recruiting
      • The Second People Hospital of Foshan Nanhai
      • Contact: Xia Jiang
      • Principal Investigator: Xia Jiang
    • Foshan, Guangdong, China
      • Recruiting
      • Foshan Nanhai District People's Hospital
      • Contact: Fuzhang Luo
    • Foshan, Guangdong, China
      • Recruiting
      • Foshan No.1 people's hospital
      • Contact: Yaozhong Kong
    • Foshan, Guangdong, China
      • Withdrawn
      • Foshan Sanshui District People's Hospital
    • Foshan, Guangdong, China
      • Recruiting
      • Foshan Second People's Hospital
      • Contact: Bo Zhang
    • Foshan, Guangdong, China
      • Withdrawn
      • Shunde People's Hospital
    • Foshan, Guangdong, China
      • Recruiting
      • Foshan Sanshui People's Hospital
      • Contact: Sinian Chen
    • Foshan, Guangdong, China
      • Not yet recruiting
      • Guangdong Provincial Hospital of Integrative Medicine
      • Contact: Min Zhang
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Huafeng Liu
      • Principal Investigator: Huafeng Liu
    • Guangzhou, Guangdong, China, 510630
      • Recruiting
      • The First Affiliated Hospital of Jinan University
      • Contact: Panna Liu
      • Principal Investigator: Panna Liu
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Third Affiliated Hospital of Sun Yat-sen University
      • Contact: Hui Peng
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
      • Contact: Gangyi Chen
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Fifth Affiliated Hospital of Guangzhou Medical University
      • Contact: Yuehong Yan
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Sixth Affiliated Hospital of Sun Yat-sen University
      • Contact: Zongpei Jiang
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangzhou First People's Hospital
      • Contact: Shuguang Qin
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong Agricultural Reclamation Central Hospital
      • Contact: Jiping Wang
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong Provincial Peoples Hospital
      • Contact: Xueqing Yu
      • Principal Investigator: Xueqing Yu
    • Guangzhou, Guangdong, China
      • Recruiting
      • Hua Du District People's Hospital of Guangzhou
      • Contact: Yunfang Zhang
    • Guangzhou, Guangdong, China
      • Recruiting
      • Panyu District people's hospital of Guangzhou
      • Contact: Minyan Xie
    • Guangzhou, Guangdong, China, 510235
      • Recruiting
      • Sun Yat-sen Memorial Hospital
      • Contact: Qiongqiong Yang
      • Principal Investigator: Qiongqiong Yang
    • Guangzhou, Guangdong, China, 225200
      • Recruiting
      • The Third Affiliated Hospital of Southern Medical University
      • Contact: Ying Tang
      • Principal Investigator: Ying Tang
    • Guangzhou, Guangdong, China, 510240
      • Recruiting
      • Guangzhou Redcross Hospital
      • Contact: Yan Liu
      • Principal Investigator: Yan Liu
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Guangdong Cliffod Hospital
      • Contact: Yanchun Wang
    • Guanzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-sen University
      • Principal Investigator: Wei Chen
    • Heyuan, Guangdong, China
      • Recruiting
      • Heyuan People's Hospital
      • Contact: Jianteng Xie
    • Huizhou, Guangdong, China, 516001
      • Recruiting
      • Huizhou First People Hospital
      • Contact: Yanbo Teng
      • Principal Investigator: Yanbo Teng
    • Huizhou, Guangdong, China
      • Recruiting
      • Huizhou Central People's Hospital
      • Contact: Yongjun Shi
    • Jiangmen, Guangdong, China
      • Recruiting
      • Jiangmen Center Hospital
      • Contact: Qingdong Xu
    • Jieyang, Guangdong, China
      • Recruiting
      • Jieyang People's Hospital
      • Contact: Qinhua Liu
    • Kaiping, Guangdong, China
      • Recruiting
      • Kaiping Center Hospital
      • Principal Investigator: Xiaojun Tan
    • Lianjiang, Guangdong, China
      • Recruiting
      • Lianjiang People's Hospital
      • Contact: Wei Chen
    • Lufeng, Guangdong, China
      • Not yet recruiting
      • Lufeng People's Hospital
      • Contact: Jinglie Xie
    • Maoming, Guangdong, China
      • Recruiting
      • Maoming Hospital of Traditional Chinese Medicine
      • Contact: Chaohui Wen
    • Maoming, Guangdong, China
      • Recruiting
      • Maoming People's Hospital
      • Contact: Yeming Lu
    • Meizhou, Guangdong, China, 514011
      • Recruiting
      • Meizhou People's Hospital
      • Contact: Xinghua Zhu
      • Principal Investigator: Xinghua Zhu
    • Meizhou, Guangdong, China, 514799
      • Recruiting
      • The Third Affiliated Hospital of Sun Yat-sen University Yuedong Hospital
      • Contact: Zhibo Liao
      • Principal Investigator: Zhibo Liao
    • Nanxiong, Guangdong, China, 512499
      • Recruiting
      • Nanxiong People Hospital
      • Contact: Lingjun Zeng
      • Principal Investigator: Lingjun Zeng
    • Puning, Guangdong, China
      • Not yet recruiting
      • Puning People's Hospital
      • Contact: Yifeng Ma
    • Qingyuan, Guangdong, China, 511518
      • Recruiting
      • Qingyuan People's Hospital
      • Contact: Zhiqiang Xue
      • Principal Investigator: Zhiqiang Xue
    • Qingyuan, Guangdong, China, 511600
      • Recruiting
      • Fogang People Hospital
      • Contact: Youhe Li
      • Principal Investigator: Youhe Li
    • Qingyuan, Guangdong, China
      • Not yet recruiting
      • Qingyuan Hospital of Traditional Chinese Medicine
      • Contact: Huaiyuan Mao
    • Shantou, Guangdong, China, 515041
      • Recruiting
      • The first Affiliated Hospital of Shantou Medical University
      • Contact: Yanqiang Peng
      • Principal Investigator: Yanqiang Peng
    • Shantou, Guangdong, China, 515144
      • Recruiting
      • Shantou Chaonan Minsheng Hospital
      • Contact: Yubin Xia
      • Principal Investigator: Yubin Xia
    • Shanwei, Guangdong, China
      • Recruiting
      • Shanwei People's Hospital
      • Contact: Jinxiong Xu
    • Shanwei, Guangdong, China
      • Recruiting
      • Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University
      • Contact: Hongbo Ye
    • Shaoguan, Guangdong, China
      • Recruiting
      • The First People's Hospital of Shaoguan
      • Contact: Bing Zhou
    • Shaoguan, Guangdong, China
      • Recruiting
      • Yuebei People's Hospital
      • Contact: Min He
    • Shaoguan, Guangdong, China, 512600
      • Recruiting
      • Wengyuan People Hospital
      • Contact: Yaoli Huang
      • Principal Investigator: Yaoli Huang
    • Shaoguan, Guangdong, China
      • Recruiting
      • Shaoguan First People's Hospital
      • Contact: Bin Zhou
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen Baoan People's Hospital
      • Contact: Jihong Chen
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen No.2 people's hospital
      • Principal Investigator: Qijun Wan
    • Shenzhen, Guangdong, China
      • Not yet recruiting
      • Shenzhen Hospital of Southern Medical University
      • Contact: Lifen Wang
    • Shenzhen, Guangdong, China, 510275
      • Recruiting
      • The Seventh Affiliated Hospital of Sun Yat-sen
      • Contact: Zhihua Zheng
      • Principal Investigator: Zhihua Zheng
    • Shenzhen, Guangdong, China
      • Not yet recruiting
      • Shenzhen Longhua District People's Hospital
      • Contact: Mingliang Hu
    • Shenzhen, Guangdong, China
      • Recruiting
      • The Eighth Affiliated Hospital of Sun Yat-sen University (Futian, Shenzhen)
      • Contact: Tiecheng Yang
    • Shunde, Guangdong, China
      • Not yet recruiting
      • ShunDe Hospital Guangzhou University of Chinese Medicine
      • Contact: Mou Liang
    • Shunde, Guangdong, China
      • Not yet recruiting
      • Shunde Hospital of Southern Medical University
      • Contact: Xianrui Dou
    • Yangjiang, Guangdong, China
      • Not yet recruiting
      • Yangjiang Hospital of Traditional Chinese Medicine
      • Contact: Yingchao Zhong
    • Yangjiang, Guangdong, China
      • Recruiting
      • Yangjiang People's Hospital
      • Contact: Yong Su
    • Yunfu, Guangdong, China
      • Recruiting
      • Yunfu People's Hospital
      • Contact: Xinyuan Liao
    • Zengcheng, Guangdong, China
      • Not yet recruiting
      • The Fourth Affiliated Hospital of Guangzhou Medical University
      • Contact: Jumei Xia
    • Zhanjiang, Guangdong, China, 524000
      • Not yet recruiting
      • The Affiliated Hospital of Guangdong Medical University
      • Contact: Huafeng Liu
      • Principal Investigator: Jie Xiao
    • Zhanjiang, Guangdong, China
      • Recruiting
      • Central People's Hospital of Zhanjiang
      • Contact: Lei Zeng
    • Zhaoqing, Guangdong, China
      • Recruiting
      • Zhaoqing first people's hospital
      • Contact: Jinquan Wu
      • Principal Investigator: Jinquan Wu
    • Zhongshan, Guangdong, China
      • Recruiting
      • Zhongshan City People's Hospital
      • Contact: Qing Ye
      • Principal Investigator: Qing Ye
    • Zhongshan, Guangdong, China
      • Withdrawn
      • Zhongshan Traditional Chinese Hospital
    • Zhongshan, Guangdong, China
      • Not yet recruiting
      • Zhongshan Xiaolan People's Hospital
      • Contact: Xianggeng Chi
    • Zhuhai, Guangdong, China
      • Recruiting
      • Zhuhai People's Hospital
      • Contact: Rui Zhang
    • Zhuhai, Guangdong, China
      • Recruiting
      • The Fifth Affiliated Hospital of Sun Yat-sen University
      • Contact: Cheng Wang
    • Zhuhai, Guangdong, China
      • Not yet recruiting
      • Jinwan Center Hospital of Zhuhai
      • Contact: Juan Pang
  • Guangxi
    • Baise, Guangxi, China
      • Recruiting
      • The Affiliated Hospital of Youjiang Ethnic Medicine College
      • Contact: Jie Wang
    • Nanning, Guangxi, China
      • Recruiting
      • The First Affiliated Hospital of Guangxi Medical University
      • Contact: Zhenhua Yang
  • Guizhou
    • Anshun, Guizhou, China, 561099
      • Recruiting
      • Anshun People Hospital
      • Contact: Xianfeng Cheng
      • Principal Investigator: Xianfeng Cheng
    • Guiyang, Guizhou, China
      • Withdrawn
      • Guizhou Province Peple's Hospital
  • Hainan
    • Haikou, Hainan, China
      • Recruiting
      • Hainan Provincial People's Hospital
      • Contact: Jiali Wei
  • Henan
    • Xinyang, Henan, China
      • Recruiting
      • Xinyang Central Hospital
      • Contact: Bo Zhang
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • The Central Hospital of Wuhan
      • Contact: Wenli Chen
    • Wuhan, Hubei, China
      • Recruiting
      • The Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
      • Contact: Chun Zhang
    • Wuhan, Hubei, China
      • Recruiting
      • Tongji Hospital, Tongji Medical College of Huazhong Science and Technology University
      • Contact: Gang Xu
    • Wuhan, Hubei, China
      • Recruiting
      • Wuhan No.1 People's Hospital
      • Contact: Yanmin Zhang
    • Wuhan, Hubei, China
      • Withdrawn
      • Yichang Central People's Hospital
    • Wuhan, Hubei, China
      • Withdrawn
      • Zhongnan Hospital of Wuhan University
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Provincial People's Hospital
      • Contact: Yumei Liang
    • Changsha, Hunan, China
      • Recruiting
      • The Third Xiangya Hospital of Central South University
      • Contact: Hao Zhang
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital Central South University
      • Contact: Xiangcheng Xiao
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China
      • Withdrawn
      • The Affiliated Hospital of Inner Mongolia Medical University
  • Jiangxi
    • Ganzhou, Jiangxi, China
      • Recruiting
      • Ganzhou People's Hospital
      • Contact: Hongxia Peng
    • Ganzhou, Jiangxi, China, 341000
      • Recruiting
      • Ganzhou Municiple Hospital
      • Contact: Zhuo Li
      • Principal Investigator: Zhuo Li
    • Jiujiang, Jiangxi, China
      • Withdrawn
      • Jiujiang No.1people's Hospital
    • Nanchang, Jiangxi, China
      • Recruiting
      • The First Affiliated Hospital of NanChang University
      • Contact: Qinkai Chen
    • Nanchang, Jiangxi, China
      • Recruiting
      • Jiangxi Province Peple's Hospital
      • Contact: Aimin Zhong
  • Ningxia
    • Yinchuan, Ningxia, China
      • Recruiting
      • General Hospital of Ningxia Medical University
      • Contact: Menghua Chen
  • Shandong
    • Qingdao, Shandong, China
      • Withdrawn
      • The Affiliated Hospital of Qingdao University
  • Shanxi
    • Xi'an, Shanxi, China
      • Withdrawn
      • The First Affiliated Hospital of Air Force Military Medical University
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Sichuan Province People's Hospital
      • Contact: Li Wang
  • Xinjiang
    • Kashi, Xinjiang, China
      • Recruiting
      • The First People's Hospital of Kashi Prefecture
      • Contact: Jie Guo
    • Shihezi, Xinjiang, China
      • Recruiting
      • The First Affiliated Hospital of Shihezi University Medical College
      • Contact: Xiaoping Yang
    • Ürümqi, Xinjiang, China
      • Withdrawn
      • The first affiliated hospital of Xinjiang medical university
    • Ürümqi, Xinjiang, China
      • Withdrawn
      • The People's hospital of Xinjiang Uygur Autonomous Region
  • Yunnan
    • Lincang, Yunnan, China
      • Recruiting
      • Fengqing People's Hospital of Yunnan Province
      • Contact: Jinfeng Guo
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Active, not recruiting
      • The First Affiliated Hospital, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aspirin; Aspirin tablet 100mg daily	Drug: Aspirin 100 mg Oral Tablet; Aspirin 100 mg tablet daily
Placebo Comparator: Matching Placebo; Placebo tablet 1 pill daily	Drug: Matching Placebo; Matching Placebo 1 pill daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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	Death for any reason.	From trial initiation to any event first occurrence, up to 5 years.
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 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.
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.
Number of Participants with cardiovascular death	Death due to CV cause.	From trial initiation to any event first occurrence, up to 5 years.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Collaborators: The George Institute
• Investigators: Study Chair: Xueqing Yu, Guangdong Provincial People's Hospital; Study Director: Muh Geot Wong, The George Institute; Study Director: Wei Chen, First Affiliated Hospital, Sun Yat-Sen University; Study Director: Zhiming Ye, Guangdong Provincial People's Hospital; Study Chair: Vlado Perkovic, The University of New South Wales Sydney; Study Director: Li Fan, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Aspirin; Dialysis; End Stage Kidney Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: GDPH-CH-2774

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified study data that supports the results will be shared following publication. Any sub-study analysis and publication will have to be reviewed and approved by the Trial Steering Committee, local Ethics and Regulatory requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No