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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02261025
Other study ID # 20120308
Secondary ID
Status Completed
Phase N/A
First received October 6, 2014
Last updated October 22, 2014
Start date January 2008
Est. completion date September 2014

Study information

Verified date October 2014
Source Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 410
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
acetylsalicylic acid
75-100mg,per day

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary survival rate 5 years Yes
Secondary cardio-cerebral event 5 years Yes
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