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Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients

Primary Purpose

Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 3

Status

Unknown status

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Aspirin

About this trial

This is an interventional prevention trial for Chronic Kidney Disease Stage 4 focused on measuring cardiovascular events, chronic kidney disease, bleedings, progression, antiinflammatory effects

Eligibility Criteria

45 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital General Universitario Gregorio MarañonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

aspirin

standard medication

Arm Description

Aspirin dosage 100 mg/day

the patients will continue with standard medication

Outcomes

Primary Outcome Measures

Cardiovascular events

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

-Evaluate the incidence of major bleeding requiring hospitalization

antiinflammatory effects of aspirin

-to analyze the antiinflammatory effect of aspirin in patients with chronic kidney disease

Full Information

NCT ID

NCT01709994

First Posted

October 17, 2012

Last Updated

October 17, 2012

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT01709994

Brief Title

Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients

Official Title

Effect of Aspirin in Primary Prevention of Cardiovascular Risk in Patients With Chronic Kidney Disease (AASER Study)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Unknown status

Study Start Date

May 2010 (undefined)

Primary Completion Date

May 2015 (Anticipated)

Study Completion Date

May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. 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).

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 3

Keywords

cardiovascular events, chronic kidney disease, bleedings, progression, antiinflammatory effects

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

97 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

aspirin

Arm Type

Active Comparator

Arm Description

Aspirin dosage 100 mg/day

Arm Title

standard medication

Arm Type

No Intervention

Arm Description

the patients will continue with standard medication

Intervention Type

Drug

Intervention Name(s)

Aspirin

Other Intervention Name(s)

ACETILSALYCILIC ACID

Intervention Description

100 mg/day of aspirin

Primary Outcome Measure Information:

Title

Cardiovascular events

Description

Time Frame

five years

Secondary Outcome Measure Information:

Title

Major bleeding

Description

-Evaluate the incidence of major bleeding requiring hospitalization

Time Frame

five years

Title

antiinflammatory effects of aspirin

Description

-to analyze the antiinflammatory effect of aspirin in patients with chronic kidney disease

Time Frame

five years

Other Pre-specified Outcome Measures:

Title

progression of chronic kidney disease

Description

to Analyze the progression of CKD

Time Frame

five years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

JOSE LUÑO, MD, PHD

Phone

0034915868319

jluno.hgugm@salud.madrid.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JOSE LUÑO, MD, PhD

Organizational Affiliation

Hospital General Universitario Gregorio Marañon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital General Universitario Gregorio Marañon

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

MARIAN GOICOECHEA, MD, PhD

Phone

0034915868319

marian.goicoechea@gmail.com

First Name & Middle Initial & Last Name & Degree

MARIAN GOICOECHEA, MD, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

35224730

Citation

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.

Results Reference

derived

PubMed Identifier

29943364

Citation

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.

Results Reference

derived

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Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients

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