Diabetes Mellitus Clinical Trial
Official title:
Aspirin Statins Or Both For The Reduction Of Thrombin Generation In Diabetic People
Despite formal recommendations, evidence of efficacy of aspirin in individuals with diabetes
is scant and controversial. While the efficacy of aspirin versus placebo in patients with
diabetes is currently under investigation in big randomized controlled trials, the putative
additive effects of aspirin and statins in this population remain to be investigated.
Moreover there are no data examining the pathophysiologic means by which aspirin with or
without statins affects thrombosis in diabetic patients.
The aim of this trial is to evaluate the efficacy of low-dose aspirin (100 mg/daily),
statins, both or neither for the reduction of thrombin generation. These preventive
strategies will be evaluated on the top of the other strategies aimed at optimizing the care
of diabetic patients in terms of metabolic control and control of the other cardiovascular
risk factors.
Despite the very high cardiovascular risk profile, evidence of efficacy of aspirin in
individuals with diabetes is scant.
The meta-analysis on the efficacy of antiplatelet therapy involving a total of about 5,000
diabetic subjects indicates a non significant reduction in the risk of major cardiovascular
events of 7%, compared with a reduction of 25% documented in secondary prevention studies.
Diabetes could represent a special case of aspirin resistance, although no specific studies
have, to our knowledge, fully explored this hypothesis. The poor platelet responsiveness to
aspirin has been recently proposed as a possible explanation of the failure of antiplatelet
therapy to prevent cardiovascular events. The reduction in the aspirin activity in some
patients is indicated by the failure in adequately suppressing thromboxane-A2 synthesis, as
documented by the presence of high levels of its urinary metabolites.
The substantial lack of clear evidence is reflected by the low use of this drug in clinical
practice; in fact, only 10% of diabetic patients are treated with aspirin for the prevention
of cardiovascular events.
On the other hand, statins provide a similar efficacy for the prevention of major
cardiovascular events in populations with and without diabetes.
It has been recently shown that platelet response to aspirin is linearly reduced with
increasing cholesterol plasma levels. The presence of dyslipidemia, particularly common
among diabetic patients, could thus be at least partially responsible for a lower efficacy
of aspirin in this population. The concomitant use of statins could thus restore the normal
platelet sensitivity to aspirin by reducing cholesterol levels
One additional reason to hypothesize a positive effect of statins in improving platelet
response to aspirin is related to their anti-inflammatory properties
While the efficacy of aspirin versus placebo in patients with diabetes is currently under
investigation, the additive effects of aspirin and statins in this population remain to be
investigated. This aspect is of particular interest in the light of the existing debate
regarding the need of multiple interventions to reduce total cardiovascular risk.
Given these premises, it is important to evaluate the effectiveness of aspirin use in
primary prevention of cardiovascular events in association with statins therapy when
included in a strategy of global risk control.
The RATIONAL Study will evaluate whether the combined use of aspirin (100 mg d) and statins
(Atorvastatin 40 mg daily) is superior to the use of these single agents for the reduction
of thrombin generation in patients with diabetes and without previous cardiovascular events.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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