Clinical trial NCT01709994: Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients
Official title: Effect of Aspirin in Primary Prevention of Cardiovascular Risk in Patients With Chronic Kidney Disease (AASER Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Kidney Disease Stage 4
Chronic Kidney Disease Stage 3
Keywords: cardiovascular events
chronic kidney disease
bleedings
progression
antiinflammatory effects
Lead sponsor: Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 97
Sex: ALL
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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.

Primary outcomes:
measure: Cardiovascular events
timeFrame: five years
Secondary outcomes:
measure: Major bleeding
timeFrame: five years
measure: antiinflammatory effects of aspirin
timeFrame: five years
Other outcomes:
measure: progression of chronic kidney disease
timeFrame: five years
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
Study officials:
affiliation: Hospital General Universitario Gregorio Marañon
name: JOSE LUÑO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
citation: Goicoechea M, de Vinuesa SG, Quiroga B, Verde E, Bernis C, Morales E, Fernandez-Juarez G, de Sequera P, Verdalles U, Delgado R, Torres A, Arroyo D, Abad S, Ortiz A, Luno J. Aspirin for Primary Prevention of Cardiovascular Disease and Renal Disease Progression in Chronic Kidney Disease Patients: a Multicenter Randomized Clinical Trial (AASER Study). Cardiovasc Drugs Ther. 2018 Jun;32(3):255-263. doi: 10.1007/s10557-018-6802-1.