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Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients

This study is currently recruiting participants.
Verified October 2012 by Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
Sponsor:
Information provided by (Responsible Party):
Jose Luño Fernandez, Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
ClinicalTrials.gov Identifier:
NCT01709994
First received: October 17, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted

October 17, 2012
October 17, 2012
May 2010
May 2015   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • Major bleeding [ Time Frame: five years ] [ Designated as safety issue: Yes ]
    -Evaluate the incidence of major bleeding requiring hospitalization
  • antiinflammatory effects of aspirin [ Time Frame: five years ] [ Designated as safety issue: No ]
    -to analyze the antiinflammatory effect of aspirin in patients with chronic kidney disease
Same as current
progression of chronic kidney disease [ Time Frame: five years ] [ Designated as safety issue: No ]
to Analyze the progression of CKD
Same as current
 
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).

Hypothesis: The low-dose aspirin reduces cardiovascular risk in patients with chronic kidney disease without increasing the risk of bleeding
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Chronic Kidney Disease Stage 4
  • Chronic Kidney Disease Stage 3
Drug: Aspirin
100 mg/day of aspirin
Other Name: ACETILSALYCILIC ACID
  • Active Comparator: aspirin
    Aspirin dosage 100 mg/day
    Intervention: Drug: Aspirin
  • No Intervention: standard medication
    the patients will continue with standard medication
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
97
May 2015
May 2015   (final data collection date for primary outcome measure)

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.
Both
45 Years to 79 Years
No
Contact: JOSE LUÑO, MD, PHD 0034915868319 jluno.hgugm@salud.madrid.org
Spain
 
NCT01709994
MG001
No
Jose Luño Fernandez, Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
Not Provided
Principal Investigator: JOSE LUÑO, MD, PhD Hospital General Universitario Gregorio Marañon
Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP