Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:26 PM
Study NCT ID:
NCT01709994
Status:
UNKNOWN
Last Update Posted:
2012-10-18
First Post:
2012-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 97}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-17', 'studyFirstSubmitDate': '2012-10-17', 'studyFirstSubmitQcDate': '2012-10-17', 'lastUpdatePostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'progression of chronic kidney disease', 'timeFrame': 'five years', 'description': 'to Analyze the progression of CKD'}], 'primaryOutcomes': [{'measure': 'Cardiovascular events', 'timeFrame': 'five years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Major bleeding', 'timeFrame': 'five years', 'description': '-Evaluate the incidence of major bleeding requiring hospitalization'}, {'measure': 'antiinflammatory effects of aspirin', 'timeFrame': 'five years', 'description': '-to analyze the antiinflammatory effect of aspirin in patients with chronic kidney disease'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiovascular events', 'chronic kidney disease', 'bleedings', 'progression', 'antiinflammatory effects'], 'conditions': ['Chronic Kidney Disease Stage 4', 'Chronic Kidney Disease Stage 3']}, 'referencesModule': {'references': [{'pmid': '35224730', 'type': 'DERIVED', '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.'}, {'pmid': '29943364', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': 'Hypothesis: The low-dose aspirin reduces cardiovascular risk in patients with chronic kidney disease without increasing the risk of bleeding'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sign informed consent\n* 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) -\n\nExclusion Criteria:\n\n* a previous cardiovascular event: cardiac arrhythmias, cardiac arrest, angina or acute myocardial infarction, stroke, carotid stenosis of more than 50%, peripheral vascular arteriopathy documented\n* hospitalization for any cause in the last three months prior to inclusion in the study allergy of acetyl-salicylic acid\n* coagulopathy from any cause\n* thrombocytopenia \\<150,000 platelets\n* liver disease from any cause\n* Infection by hepatitis B virus, hepatitis C or HIV\n* immunosuppressive treatment within 12 weeks before inclusion in the study\n* Major bleeding events including gastrointestinal bleeding and brain hemorrhage.\n* hemoglobinopathies (eg sickle cell disease or thalassemia of any kind)\n* 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.\n* uncontrolled inflammatory disease or symptomatic (eg rheumatoid arthritis, lupus, Chrom disease or bowel inflammatory disease)\n* hemolysis\n* treatment with oral anticoagulation and / or antiplatelet therapy prior.\n* poorly controlled hypertension (\\> 160/90 mm Hg) -pregnancy or breast-\n* women of childbearing potential not using effective contraception.'}, 'identificationModule': {'nctId': 'NCT01709994', 'briefTitle': 'Primary Cardiovascular Risk Prevention With Aspirin in Chronic Kidney Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales'}, 'officialTitle': 'Effect of Aspirin in Primary Prevention of Cardiovascular Risk in Patients With Chronic Kidney Disease (AASER Study)', 'orgStudyIdInfo': {'id': 'MG001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'aspirin', 'description': 'Aspirin dosage 100 mg/day', 'interventionNames': ['Drug: Aspirin']}, {'type': 'NO_INTERVENTION', 'label': 'standard medication', 'description': 'the patients will continue with standard medication'}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['ACETILSALYCILIC ACID'], 'description': '100 mg/day of aspirin', 'armGroupLabels': ['aspirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28007', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'MARIAN GOICOECHEA, MD, PhD', 'role': 'CONTACT', 'email': 'marian.goicoechea@gmail.com', 'phone': '0034915868319'}, {'name': 'MARIAN GOICOECHEA, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital General Universitario Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'JOSE LUÑO, MD, PHD', 'role': 'CONTACT', 'email': 'jluno.hgugm@salud.madrid.org', 'phone': '0034915868319'}], 'overallOfficials': [{'name': 'JOSE LUÑO, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General Universitario Gregorio Marañon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Headmaster of Nephrology Department', 'investigatorFullName': 'Jose Luño Fernandez', 'investigatorAffiliation': 'Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales'}}}}