Chronic Kidney Disease Stage 3, Chronic Kidney Disease Stage 4
Conditions
Keywords
cardiovascular events, chronic kidney disease, bleedings, progression, antiinflammatory effects
Brief summary
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
Hypothesis: The low-dose aspirin reduces cardiovascular risk in patients with chronic kidney disease without increasing the risk of bleeding
Interventions
DRUGAspirin
100 mg/day of aspirin
Sponsors
Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular events | five years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major bleeding | five years | -Evaluate the incidence of major bleeding requiring hospitalization |
| antiinflammatory effects of aspirin | five years | -to analyze the antiinflammatory effect of aspirin in patients with chronic kidney disease |
Other
| Measure | Time frame | Description |
|---|---|---|
| progression of chronic kidney disease | five years | to Analyze the progression of CKD |
Countries
Spain
Contacts
Primary ContactJOSE LUÑO, MD, PHD
Outcome results
None listed