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Clinical Trials in Spain / NCT00725127
Active, not recruiting Phase 4

Chronotherapy with Low-dose Aspirin for Primary Prevention

NCT00725127 · tracked via the Priya Life Science Spain tracker
Sponsor
University of Vigo
Phase
Phase 4
Started
2008-10
Last updated
2024-12-06

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

aspirin →aspirin →

aspirin: 100 mg/day upon awakening for five years

aspirin: 100 mg/day at bedtime for five years

Study summary

Brief summary:

Aspirin (ASA) has been shown to provide marked benefits in primary and secondary prevention of cardiovascular events. Substantial evidence suggests that low-dose ASA therapy should also be used as a primary prevention strategy in men and women with diabetes who are at high cardiovascular risk. On the other hand, there is current evidence on the potential benefits of low-dose ASA therapy in subjects with impaired fasting glucose, including those with metabolic syndrome. Most important, previous laboratory animal and clinical trial research convincingly demonstrates administration time-dependent (with reference to circadian rhythms) effects of ASA. Thus, the effects of ASA upon lipoperoxides, b-adrenergic receptors, and blood pressure (BP) in clinically healthy subjects depend on the circadian timing of ASA administration. The administration-time-dependent influence of ASA on BP was previously demonstrated in a randomized trial on healthy women and other independent double-blind, randomized, placebo-controlled clinical trials conducted, first, on clinically healthy subjects, a second one on normotensive and hypertensive subjects, a third one on pregnant women at high risk for preeclampsia and a fourth one in previously untreated patients with mild hypertension. The findings of these BP studies are consistent; BP-lowering effect of low-dose ASA is achieved when administered at bedtime but not upon awakening.

In keeping with the chronopharmacological effects of ASA and the previous findings suggesting that ASA at low dose may exert a potential beneficial effect on BP, endothelium function and cardiovascular function, this prospective, randomized, parallel-arm study will investigate the potential influence of ASA on the primary prevention of cardiovascular, cerebrovascular and renal events in subjects with either impaired fasting glucose (≥ 100 mg/dl) or previous diagnosis of type 2 diabetes mellitus, who will receive low-dose ASA (100 mg/day) at different circadian times (upon awakening or at bedtime) in relation to their rest-activity cycle.

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Male or female subjects ≥ 50 years of age. * Impaired fasting glucose (≥ 100 and \< 126 mg/dl) in the last available blood test prior (≤ 3 months) to randomization, or diagnosis of type 2 diabetes prior to randomization. * All subjects must have at randomization a conventional clinic systolic/diastolic BP \< 160/100 mmHg. * Informed consent to participate in the study prior to any study procedures. Exclusion Criteria: * Known or suspected contraindications, including history of allergy to ASA. * Uncontrolled essential hypertension of Grade 2-3, i.e., systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg before randomization. * Evidence of a secondary form of hypertension, to include coarctation of the aorta, hyperaldosteronism, renal artery stenosis, or pheochromocytoma. * Known Keith-Wagener grade III or IV hypertensive retinopathy. * History of hypertensive encephalopathy, cerebrovascular event, transient ischemic cerebral attack, or myocardial infarction prior to randomization. * Type 1 diabetes mellitus. * History of heart failure. * Second or third degree heart block without a pacemaker. * Concomitant unstable angina pectoris. * Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia. * Clinically significant valvular heart disease. * Evidence of hepatic disease as determined by one of the following: ALT or AST values \> 2 x UNL known before randomization, a history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt. * Diagnosis of chronic kidney disease prior to randomization. * History of malignancy including leukemia and lymphoma (but not basal cell skin cancer), or any other severe, life-threatening disease within the past five years. * Any previous history of a systemic autoimmune disease. * History of drug or alcohol abuse within the last two years. * Use of any disallowed concomitant medication. * Inability to communicate and comply with all study requirements. * Persons directly involved in the execution of this protocol.

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
CS Friol Friol Lugo
CS Fingoi Lugo Lugo
Complexo Hospitalario Universitario de Ourense Ourense Orense
CS A Estrada A Estrada Pontevedra
CS Baiona Baiona Pontevedra
CS Bueu Bueu Pontevedra
CS A Guarda La Guardia Pontevedra
CS Valmiñor Nigrán Pontevedra
CS Panxón Nigrán Pontevedra
CS Lerez Pontevedra Pontevedra
CS Tomiño Tomiño Pontevedra
Bioengineering & Chronobilogy Labs., University of Vigo Vigo Pontevedra
CS Calle Cuba Vigo Pontevedra
CS A Doblada Vigo Pontevedra
CS Coia Vigo Pontevedra
CS Sardoma Vigo Pontevedra
CS Teis Vigo Pontevedra
CS Vilaboa Vilaboa Pontevedra
CS San Roque Vilagarcía de Arousa Pontevedra

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Non-invasive Training of the Inspiratory Muscles in Athletic Women Active, not recruiting
Immersive Virtual Reality and Exercise Programs in Multiple Sclerosis: ExeRVIEM III Recruiting

Other trials for the same condition

DigiDiab Pilot Spain - Nursing Home and Domiciliary Nursing Care Recruiting
AMBITION 7: A Research Study Investigating How Well Zenagamtide Lowers Blood Sugar and Body Weight Compared to Insulin Glargine in People With Type 2 Diabetes and Increased Risk of Diseases That Affect the Heart and Blood Vessels Treated With 1-3 Other Diabetes Medications Recruiting
DigiDiab Pilot: Impact Study Hospital Recruiting
A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00725127 on ClinicalTrials.gov ↗ ← All trials in Spain