Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients
NCT ID: NCT01709994
Last Updated: 2012-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
97 participants
INTERVENTIONAL
2010-05-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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aspirin
Aspirin dosage 100 mg/day
Aspirin
100 mg/day of aspirin
standard medication
the patients will continue with standard medication
No interventions assigned to this group
Interventions
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Aspirin
100 mg/day of aspirin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
79 Years
ALL
No
Sponsors
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Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
OTHER
Responsible Party
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Jose Luño Fernandez
Headmaster of Nephrology Department
Principal Investigators
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JOSE LUÑO, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario Gregorio Marañon
Locations
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Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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MARIAN GOICOECHEA, MD, PhD
Role: primary
References
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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.
Other Identifiers
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MG001
Identifier Type: -
Identifier Source: org_study_id