Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients

Study Overview
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Brief Summary
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The objective of the study is to examine whether the use of low-dose aspirin (75-100 mg / day) reduces the risk of cardiovascular disease in patients with chronic kidney disease (stage 3 or 4).

Detailed Description
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Hypothesis: The low-dose aspirin reduces cardiovascular risk in patients with chronic kidney disease without increasing the risk of bleeding

Official Title
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Effect of Aspirin in Primary Prevention of Cardiovascular Risk in Patients With Chronic Kidney Disease (AASER Study)

Conditions
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Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 3

Intervention / Treatment
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* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sign informed consent males 45-79 years or females 55-79 years. -Stage 3 or 4 CKD (estimated GFR by MDRD abbreviated, between 15 and 60 ml / min/1.73 m2) - Exclusion Criteria: a previous cardiovascular event: cardiac arrhythmias, cardiac arrest, angina or acute myocardial infarction, stroke, carotid stenosis of more than 50%, peripheral vascular arteriopathy documented hospitalization for any cause in the last three months prior to inclusion in the study allergy of acetyl-salicylic acid coagulopathy from any cause thrombocytopenia <150,000 platelets liver disease from any cause Infection by hepatitis B virus, hepatitis C or HIV immunosuppressive treatment within 12 weeks before inclusion in the study Major bleeding events including gastrointestinal bleeding and brain hemorrhage. hemoglobinopathies (eg sickle cell disease or thalassemia of any kind) active malignancy (except non-melanoma skin cancer). May be included in the study patients with malignant neoplasia who have remained disease-free for at least the previous 5 years. uncontrolled inflammatory disease or symptomatic (eg rheumatoid arthritis, lupus, Chrom disease or bowel inflammatory disease) hemolysis treatment with oral anticoagulation and / or antiplatelet therapy prior. poorly controlled hypertension (> 160/90 mm Hg) -pregnancy or breast- women of childbearing potential not using effective contraception.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: aspirin<br>Aspirin dosage 100 mg/day | Drug: Aspirin<br>* 100 mg/day of aspirin<br>* Other names: ACETILSALYCILIC ACID;|
| No Intervention: standard medication<br>the patients will continue with standard medication | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular events | To assess the benefit of treatment with low-dose aspirin in the primary prevention of cardiovascular events (incidence of the composite endpoint: death, acute coronary syndrome, stroke or nonfatal acute peripheral arteriopathy disease) in patients with chronic kidney disease who are not in dialysis or renal transplant. | five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding | -Evaluate the incidence of major bleeding requiring hospitalization | five years | 
| antiinflammatory effects of aspirin | -to analyze the antiinflammatory effect of aspirin in patients with chronic kidney disease | five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular events, chronic kidney disease, bleedings, progression, antiinflammatory effects