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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
  Purpose

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 Intervention Phase
Chronic Kidney Disease Stage 4
Chronic Kidney Disease Stage 3
 Drug: Aspirin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Aspirin in Primary Prevention of Cardiovascular Risk in Patients With Chronic Kidney Disease (AASER Study)

Resource links provided by NLM:

Drug Information available for: Aspirin
U.S. FDA Resources

Further study details as provided by Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales:

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:
  • 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


Other Outcome Measures:
  • progression of chronic kidney disease [ Time Frame: five years ] [ Designated as safety issue: No ]
    to Analyze the progression of CKD


Estimated Enrollment: 97
Study Start Date: May 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   45 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 17, 2012
Last Updated: October 17, 2012
Health Authority: 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:
cardiovascular events
chronic kidney disease
bleedings
progression
antiinflammatory effects

Additional relevant MeSH terms:
Kidney Failure, Chronic
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
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013