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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Stage 4 Chronic Kidney Disease Stage 3 Drug: Aspirin Phase 3

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

Study Design

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Aspirin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: aspirin
Aspirin dosage 100 mg/day
Drug: Aspirin
100 mg/day of aspirin
Other Name: ACETILSALYCILIC ACID
No Intervention: standard medication
the patients will continue with standard medication


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Major bleeding [ Time Frame: five years ]
    -Evaluate the incidence of major bleeding requiring hospitalization

  2. antiinflammatory effects of aspirin [ Time Frame: five years ]
    -to analyze the antiinflammatory effect of aspirin in patients with chronic kidney disease


Other Outcome Measures:
  1. progression of chronic kidney disease [ Time Frame: five years ]
    to Analyze the progression of CKD


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: JOSE LUÑO, MD, PHD 0034915868319 jluno.hgugm@salud.madrid.org

Locations
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         
Sponsors and Collaborators
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 Marañon
More Information

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     History of Changes
Other Study ID Numbers: MG001
First Posted: October 18, 2012    Key Record Dates
Last Update Posted: October 18, 2012
Last Verified: October 2012

Keywords provided by Jose Luño Fernandez, Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales:
cardiovascular events
chronic kidney disease
bleedings
progression
antiinflammatory effects

Additional relevant MeSH terms:
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