Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients

Overview

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).

Full Title of Study: “Effect of Aspirin in Primary Prevention of Cardiovascular Risk in Patients With Chronic Kidney Disease (AASER Study)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2015

Detailed Description

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

Interventions

  • Drug: Aspirin
    • 100 mg/day of aspirin

Arms, Groups and Cohorts

  • Active Comparator: aspirin
    • Aspirin dosage 100 mg/day
  • No Intervention: standard medication
    • the patients will continue with standard medication

Clinical Trial Outcome Measures

Primary Measures

  • Cardiovascular events
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jose Luño Fernandez, Headmaster of Nephrology Department – Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
  • Overall Official(s)
    • JOSE LUÑO, MD, PhD, Principal Investigator, Hospital General Universitario Gregorio Marañon
  • Overall Contact(s)
    • JOSE LUÑO, MD, PHD, 0034915868319, jluno.hgugm@salud.madrid.org

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