HemodialysisNCT02261025
The Effect Of Aspirin On Survival in in Patients Undergoing Chronic Hemodialysis
A study testing acetylsalicylic acid in people with Hemodialysis, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
The aim of present study is to examine the effect of low-dose aspirin on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- acetylsalicylic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients aged 18 to 85, undergoing chronic hemodialysis, who have none of the following exclusion criteria.
Who cannot join
- History of gastric or duodenal ulcers Known allergy to aspirin or other NSAIDs
- -
About this study
The aim of present study is to examine the effect of low-dose aspirin on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis.
Read the detailed description
This study prospectively evaluate the impacts of low dose aspirin on survival and cardio-cerebral vascular events in a large cohort of Chinese patients undergoing chronic hemodialysis. Between January 2008, consecutive patients with hemodialysis with aspirin were enrolled.We examine the association of aspirin with all-cause mortality in patients matched by propensity scores using the Kaplan-Meier method and Cox models in "intention-to-treat" analyses.The secondary endpoint was rate of cardio-cerebral events.
- Conditions
- Hemodialysis
- Being tested
- acetylsalicylic acid
- Keywords
- aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylsalicylic acidDrug
Also called Aspirin
75-100mg,per day
| Study group | Role | What they receive |
|---|---|---|
| Aspirin group | Experimental | Aspirin 75-100mg,per day，oral Receives: Drug: acetylsalicylic acid |
| non-aspirin group | No intervention | No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
Measured: 5 years
Secondary outcomes (1)
cardio-cerebral event
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startJan 2008
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Min Jin, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261025
- Sponsor's protocol ID
- 20120308
- Status last verified
- Oct 2014
- First submitted
- 6 Oct 2014
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu J, Pan Y, Chen L, Qiao QY, Wang J, Pan LH, Gu YH, Gu HF, Fu SK, Jin HM. Low-dose aspirin for prevention of cardiovascular disease in patients on hemodialysis: A 5-y prospective cohort study. Hemodial Int. 2016 Oct;20(4):548-557. doi: 10.1111/hdi.12409. Epub 2016 Mar 1.
PubMed 26932276
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Aspirin On Survival in in Patients Undergoing Chronic Hemodialysis
- ClinicalTrials.gov ID
- NCT02261025
- Acronym / sponsor ID
- 20120308
- Conditions
- Hemodialysis
- Keywords
- aspirin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of present study is to examine the effect of low-dose aspirin on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis.
Detailed description
This study prospectively evaluate the impacts of low dose aspirin on survival and cardio-cerebral vascular events in a large cohort of Chinese patients undergoing chronic hemodialysis. Between January 2008, consecutive patients with hemodialysis with aspirin were enrolled.We examine the association of aspirin with all-cause mortality in patients matched by propensity scores using the Kaplan-Meier method and Cox models in "intention-to-treat" analyses.The secondary endpoint was rate of cardio-cerebral events.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin group | Experimental | Drug: acetylsalicylic acidAspirin 75-100mg,per day，oral |
| non-aspirin group | No intervention | –No interventions |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients aged 18 to 85, undergoing chronic hemodialysis, who have none of the following exclusion criteria.
Key exclusion criteria (2 listed)
- History of gastric or duodenal ulcers Known allergy to aspirin or other NSAIDs
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetylsalicylic acidAlso: Aspirin75-100mg,per day | Drug | Aspirin group |
Primary outcome
survival rate
Time frame: 5 years
1 secondary outcome
cardio-cerebral event
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2014.
- Derived from this study: PubMed 26932276Liu J, Pan Y, Chen L, Qiao QY, Wang J, Pan LH, Gu YH, Gu HF, Fu SK, Jin HM. Low-dose aspirin for prevention of cardiovascular disease in patients on hemodialysis: A 5-y prospective cohort study. Hemodial Int. 2016 Oct;20(4):548-557. doi: 10.1111/hdi.12409. Epub 2016 Mar 1.
Related trials for Hemodialysis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing acetylsalicylic acid in people with Hemodialysis, run by Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02261025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2014.