Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients

Chronic Kidney Disease Stage 3 Clinical Trial

Official title:

Effect of Aspirin in Primary Prevention of Cardiovascular Risk in Patients With Chronic Kidney Disease (AASER Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01709994
• Other study ID #: MG001
• Status: Recruiting
• Phase: Phase 3
• First received: October 17, 2012
• Last updated: October 17, 2012
• Start date: May 2010
• Est. completion date: May 2015

Study information

• Verified date: October 2012
• Source: Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
• Contact: JOSE LUÑO, MD, PHD
• Phone: 0034915868319
• Email: jluno.hgugm[@]salud.madrid.org
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 97
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 79 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 3
• Chronic Kidney Disease Stage 4
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Aspirin
100 mg/day of aspirin

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	progression of chronic kidney disease	to Analyze the progression of CKD	five years	No
Primary	Cardiovascular events	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.	five years	No
Secondary	Major bleeding	-Evaluate the incidence of major bleeding requiring hospitalization	five years	Yes
Secondary	antiinflammatory effects of aspirin	-to analyze the antiinflammatory effect of aspirin in patients with chronic kidney disease	five years	No