Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients

NCT ID: NCT01709994

Last Updated: 2012-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2015-05-31

Brief Summary

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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).

Detailed Description

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

Conditions

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Chronic Kidney Disease Stage 4 Chronic Kidney Disease Stage 3

Keywords

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cardiovascular events chronic kidney disease bleedings progression antiinflammatory effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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aspirin

Aspirin dosage 100 mg/day

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

100 mg/day of aspirin

standard medication

the patients will continue with standard medication

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aspirin

100 mg/day of aspirin

Intervention Type DRUG

Other Intervention Names

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ACETILSALYCILIC ACID

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales

OTHER

Sponsor Role lead

Responsible Party

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Jose Luño Fernandez

Headmaster of Nephrology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JOSE LUÑO, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario Gregorio Marañon

Locations

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Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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JOSE LUÑO, MD, PHD

Role: CONTACT

Phone: 0034915868319

Email: [email protected]

Facility Contacts

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MARIAN GOICOECHEA, MD, PhD

Role: primary

References

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Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

Reference Type DERIVED
PMID: 35224730 (View on PubMed)

Goicoechea M, de Vinuesa SG, Quiroga B, Verde E, Bernis C, Morales E, Fernandez-Juarez G, de Sequera P, Verdalles U, Delgado R, Torres A, Arroyo D, Abad S, Ortiz A, Luno J. Aspirin for Primary Prevention of Cardiovascular Disease and Renal Disease Progression in Chronic Kidney Disease Patients: a Multicenter Randomized Clinical Trial (AASER Study). Cardiovasc Drugs Ther. 2018 Jun;32(3):255-263. doi: 10.1007/s10557-018-6802-1.

Reference Type DERIVED
PMID: 29943364 (View on PubMed)

Other Identifiers

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MG001

Identifier Type: -

Identifier Source: org_study_id