Overview

Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients

Status:
Unknown status
Trial end date:
2015-05-01
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
Treatments:
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.