Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients

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

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).

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Disease Stage 3; Chronic Kidney Disease Stage 4
• Intervention / Treatment: Drug: Aspirin

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 97
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: JOSE LUÑO, MD, PHD; Phone Number: 0034915868319; Email: jluno.hgugm@salud.madrid.org

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital General Universitario Gregorio Maranon
    • Contact: MARIAN GOICOECHEA, MD, PhD; Phone Number: 0034915868319; Email: marian.goicoechea@gmail.com
    • Principal Investigator: MARIAN GOICOECHEA, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: aspirin; Aspirin dosage 100 mg/day	Drug: Aspirin; 100 mg/day of aspirin; Other Names: ACETILSALYCILIC ACID
No Intervention: standard medication; the patients will continue with standard medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression of chronic kidney disease	to Analyze the progression of CKD	five years

Collaborators and Investigators

• Sponsor: Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
• Investigators: Principal Investigator: JOSE LUÑO, MD, PhD, Hospital General Universitario Gregorio Maranon

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: October 17, 2012
• First Submitted That Met QC Criteria: October 17, 2012
• First Posted (Estimate): October 18, 2012

Study Record Updates

• Last Update Posted (Estimate): October 18, 2012
• Last Update Submitted That Met QC Criteria: October 17, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: chronic kidney disease; cardiovascular events; progression; bleedings; antiinflammatory effects
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: MG001