The Effect Of Aspirin On Survival in in Patients Undergoi... | NCT02261025

Studies
The Effect Of Aspirin On Survival in in Patients Undergoing Chronic Hemodialysis

NCT02261025

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Completed

Last Update Posted

Oct 23, 2014Estimated

Enrollment

410Actual

Phase

Not Applicable

Conditions

Hemodialysis

Interventions

acetylsalicylic acid

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Oct 6, 2014

First Submission Date that Met QC Criteria

Oct 6, 2014

First Posted Date

Oct 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2014

Last Update Posted Date

Oct 23, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hui Min Jin, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

410Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aspirin group	Experimental	Aspirin 75-100mg,per day，oral	Drug: acetylsalicylic acid
non-aspirin group	No Intervention	No interventions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
acetylsalicylic acid	Drug	75-100mg,per day	Aspirin group	Aspirin

Measure	Description	Time Frame
survival rate		5 years

Measure	Description	Time Frame
cardio-cerebral event		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients aged 18 to 85, undergoing chronic hemodialysis, who have none of the following exclusion criteria.

Exclusion Criteria:

History of gastric or duodenal ulcers Known allergy to aspirin or other NSAIDs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26932276	Derived	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.

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives