Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Jose Luño Fernandez, Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
First received: October 17, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
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).
Chronic Kidney Disease Stage 4
Chronic Kidney Disease Stage 3
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
||Effect of Aspirin in Primary Prevention of Cardiovascular Risk in Patients With Chronic Kidney Disease (AASER Study)
Primary Outcome Measures:
- Cardiovascular events [ Time Frame: five years ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2015 (Final data collection date for primary outcome measure)
Active Comparator: aspirin
Aspirin dosage 100 mg/day
100 mg/day of aspirin
Other Name: ACETILSALYCILIC ACID
No Intervention: standard medication
the patients will continue with standard medication
Hypothesis: The low-dose aspirin reduces cardiovascular risk in patients with chronic kidney disease without increasing the risk of bleeding
|Ages Eligible for Study:
||45 Years to 79 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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) -
- 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)
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01709994
|Hospital General Universitario Gregorio Marañon
|Madrid, Spain, 28007 |
|Contact: MARIAN GOICOECHEA, MD, PhD 0034915868319 firstname.lastname@example.org |
|Principal Investigator: MARIAN GOICOECHEA, MD, PhD |
Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
||JOSE LUÑO, MD, PhD
||Hospital General Universitario Gregorio Marañon
No publications provided
||Jose Luño Fernandez, Headmaster of Nephrology Department, Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 17, 2012
||October 17, 2012
||Spain: Ethics Committee
Spain: Spanish Agency of Medicines
Keywords provided by Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales:
chronic kidney disease
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 02, 2015
Renal Insufficiency, Chronic
Anti-Inflammatory Agents, Non-Steroidal
Central Nervous System Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents