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Clinical Trial Details

Trial ID: L1767
Source ID: NCT00725127
Associated Drug: Aspirin
Title: Chronotherapy with Low-dose Aspirin for Primary Prevention
Acronym: CARING
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: aspirin|DRUG: aspirin
Outcome Measures: Primary: To evaluate the effects of awakening vs. bedtime 100 mg/day ASA administration in subjects with impaired fasting glucose or type 2 diabetes on primary prevention of cardiovascular, cerebrovascular and renal fatal, and non-fatal events., Five years | Secondary: To evaluate the effects of awakening vs. bedtime 100 mg/day ASA administration on primary prevention of cardiovascular fatal and non-fatal events (including cardiovascular death, myocardial infarction, angina pectoris, and coronary revascularization)., Five years|To evaluate the effects of awakening vs. bedtime 100 mg/day ASA administration on primary prevention of cerebrovascular fatal and non-fatal events (including hemorrhagic stroke, ischemic stroke, and transient ischemic attack)., Five years|To evaluate the effects of awakening vs. bedtime 100 mg/day ASA administration on primary prevention of chronic kidney disease and/or congestive heart failure, and/or peripheral artery disease., Five years|To demonstrate that 100 mg/day ASA at bedtime offers a similar safety profile than 100 mg/day ASA upon awakening, Five years|To demonstrate that compliance with 100 mg/day ASA at bedtime is similar to that with 100 mg/day ASA upon awakening., Five years|To evaluate, for all previous objectives, potential gender differences in the benefits of low-dose ASA for primary prevention., Five years|To evaluate, for all previous objectives, potential differences in the benefits of low-dose ASA for primary prevention between patients with and without diabetes., Five years|To evaluate, for all previous objectives, potential differences in the benefits of low-dose ASA for primary prevention between subjects with and without metabolic syndrome., Five years
Sponsor/Collaborators: Sponsor: University of Vigo
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 3200
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2008-10
Completion Date: 2026-06-30
Results First Posted:
Last Update Posted: 2024-12-06
Locations: CS Friol, Friol, Lugo, 27220, Spain|CS Baiona, Baiona, Pontevedra, 36300, Spain|CS Bueu, Bueu, Pontevedra, 36930, Spain|CS A Estrada, La Estrada, Pontevedra, 26680, Spain|CS A Guarda, La Guardia, Pontevedra, 36780, Spain|CS Valmiñor, Nigran, Pontevedra, 36250, Spain|CS Panxón, Nigrán, Pontevedra, 36340, Spain|CS Tomiño, Tomiño, Pontevedra, 36200, Spain|Bioengineering & Chronobilogy Labs., University of Vigo, Vigo, Pontevedra, 36200, Spain|CS Calle Cuba, Vigo, Pontevedra, 36202, Spain|CS A Doblada, Vigo, Pontevedra, 36205, Spain|CS Coia, Vigo, Pontevedra, 36209, Spain|CS Sardoma, Vigo, Pontevedra, 36214, Spain|CS Teis, Vigo, Pontevedra, 36216, Spain|CS Vilaboa, Vilaboa, Pontevedra, 36141, Spain|CS San Roque, Vilagarcía De Arousa, Pontevedra, 36600, Spain|CS Fingoi, Lugo, 27002, Spain|Complexo Hospitalario Universitario de Ourense, Orense, 32005, Spain|CS Lerez, Pontevedra, 36156, Spain
URL: https://clinicaltrials.gov/show/NCT00725127