Overview
Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients
Status:
Unknown status
Unknown status
Trial end date:
2015-05-01
2015-05-01
Target enrollment:
0
0
Participant gender:
All
All
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).Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades RenalesTreatments:
Aspirin
Criteria
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.