Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients
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ClinicalTrials.gov Identifier: NCT01709994 |
Recruitment Status : Unknown
Verified October 2012 by Jose Luño Fernandez, Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales.
Recruitment status was: Recruiting
First Posted : October 18, 2012
Last Update Posted : October 18, 2012
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Condition or disease | Intervention/treatment | Phase |
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Chronic Kidney Disease Stage 4 Chronic Kidney Disease Stage 3 | Drug: Aspirin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 97 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Effect of Aspirin in Primary Prevention of Cardiovascular Risk in Patients With Chronic Kidney Disease (AASER Study) |
Study Start Date : | May 2010 |
Estimated Primary Completion Date : | May 2015 |
Estimated Study Completion Date : | May 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: aspirin
Aspirin dosage 100 mg/day
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Drug: Aspirin
100 mg/day of aspirin
Other Name: ACETILSALYCILIC ACID |
No Intervention: standard medication
the patients will continue with standard medication
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- 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.
- 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
- progression of chronic kidney disease [ Time Frame: five years ]to Analyze the progression of CKD

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Ages Eligible for Study: | 45 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709994
Contact: JOSE LUÑO, MD, PHD | 0034915868319 | jluno.hgugm@salud.madrid.org |
Spain | |
Hospital General Universitario Gregorio Marañon | Recruiting |
Madrid, Spain, 28007 | |
Contact: MARIAN GOICOECHEA, MD, PhD 0034915868319 marian.goicoechea@gmail.com | |
Principal Investigator: MARIAN GOICOECHEA, MD, PhD |
Principal Investigator: | JOSE LUÑO, MD, PhD | Hospital General Universitario Gregorio Marañon |
Responsible Party: | Jose Luño Fernandez, Headmaster of Nephrology Department, Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales |
ClinicalTrials.gov Identifier: | NCT01709994 |
Other Study ID Numbers: |
MG001 |
First Posted: | October 18, 2012 Key Record Dates |
Last Update Posted: | October 18, 2012 |
Last Verified: | October 2012 |
cardiovascular events chronic kidney disease bleedings progression antiinflammatory effects |
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |