Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients

Phase 3

• Conditions: Chronic Kidney Disease Stage 4; Chronic Kidney Disease Stage 3
• Interventions: Drug: Aspirin

• Registration Number: NCT01709994
• Lead Sponsor: Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales

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

Study Timeline

• Study Start: 2010-05
• Status Verified: 2012-10
• Study First Submitted: 2012-10-17
• Study First Submitted QC: 2012-10-17
• Last Update Submitted: 2012-10-17
• Study First Posted: 2012-10-18
• Last Update Posted: 2012-10-18
• Primary Completion: 2015-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 97

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aspirin	Aspirin	Aspirin dosage 100 mg/day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital General Universitario Gregorio Marañon; 🇪🇸 Madrid, Spain