Chronotherapy With Low-dose Aspirin for Primary Prevention
Status:
Recruiting
Trial end date:
2026-06-01
Target enrollment:
Participant gender:
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.