Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients
This study is currently recruiting participants.
(see Contacts and Locations)
Verified October 2012 by Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
Sponsor:
Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales
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
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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:
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
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
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 Diseases Renal Insufficiency, Chronic Renal Insufficiency Urologic Diseases Aspirin Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antipyretics Antirheumatic Agents Cardiovascular Agents Central Nervous System Agents |
Cyclooxygenase Inhibitors Enzyme Inhibitors Fibrin Modulating Agents Fibrinolytic Agents Hematologic Agents Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Platelet Aggregation Inhibitors Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015