NCT01709994

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
97

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2010

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

5 years

First QC Date

October 17, 2012

Last Update Submit

October 17, 2012

Conditions

Chronic Kidney Disease Stage 4Chronic Kidney Disease Stage 3

Keywords

cardiovascular eventschronic kidney diseasebleedingsprogressionantiinflammatory effects

Outcome Measures

Primary Outcomes (1)

  • 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.

    five years

Secondary Outcomes (2)

  • Major bleeding

    five years

  • antiinflammatory effects of aspirin

    five years

Other Outcomes (1)

  • progression of chronic kidney disease

    five years

Study Arms (2)

aspirin

ACTIVE COMPARATOR

Aspirin dosage 100 mg/day

Drug: Aspirin

standard medication

NO INTERVENTION

the patients will continue with standard medication

Interventions

AspirinDRUG

100 mg/day of aspirin

Also known as: ACETILSALYCILIC ACID
aspirin

Eligibility Criteria

Age45 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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) -

You may not qualify if:

  • a previous cardiovascular event: cardiac arrhythmias, cardiac arrest, angina or acute myocardial infarction, stroke, carotid stenosis of more than 50%, peripheral vascular arteriopathy documented
  • coagulopathy from any cause
  • thrombocytopenia \<150,000 platelets
  • liver disease from any cause
  • Infection by hepatitis B virus, hepatitis C or HIV
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, 28007, Spain

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35224730DERIVED

  • 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.

    PMID: 29943364DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicDisease Progression

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • JOSE LUÑO, MD, PhD

    Hospital General Universitario Gregorio Marañon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JOSE LUÑO, MD, PHD

CONTACT

0034915868319jluno.hgugm@salud.madrid.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Headmaster of Nephrology Department

Study Record Dates

First Submitted

October 17, 2012

First Posted

October 18, 2012

Study Start

May 1, 2010

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 18, 2012

Record last verified: 2012-10

Locations

ES(1)