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

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:

MedlinePlus related topics: Kidney Diseases

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 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

ClinicalTrials.gov processed this record on September 26, 2016

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