Aspirin Statins Or Both For The Reduction Of Thrombin Generation In Diabetic People
NCT ID: NCT00793754
Last Updated: 2011-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2009-03-31
2011-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
No interventions assigned to this group
2
Aspirin 100 mg / day
Aspirin
100 mg / day for 8 weeks
3
Atorvastatin 40 mg / day
Atorvastatin
40 mg / day for 8 weeks
4
Aspirin 100 mg / day + Atorvastatin 40 mg / day
Aspirin + Atorvastatin
Aspirin 100 mg / day + Atorvastatin 40 mg / day for 8 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aspirin
100 mg / day for 8 weeks
Atorvastatin
40 mg / day for 8 weeks
Aspirin + Atorvastatin
Aspirin 100 mg / day + Atorvastatin 40 mg / day for 8 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least 50 years old
Exclusion Criteria
* current or past (within last 30 days) treatment with aspirin
* current or past (within last 180 days) treatment with statins
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundacion GESICA
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Fundacion GESICA
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alejandro Macchia, MD
Role: PRINCIPAL_INVESTIGATOR
Fundacion GESICA
Hernan Doval, MD
Role: PRINCIPAL_INVESTIGATOR
Fundacion GESICA
Juan J Fuselli, MD
Role: PRINCIPAL_INVESTIGATOR
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Pablo D Comignani, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Aleman
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)
Buenos Aires, , Argentina
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Macchia A, Laffaye N, Comignani PD, Cornejo Pucci E, Igarzabal C, Scazziota AS, Herrera L, Mariani JA, Bragagnolo JC, Catalano H, Tognoni G, Nicolucci A. Statins but not aspirin reduce thrombotic risk assessed by thrombin generation in diabetic patients without cardiovascular events: the RATIONAL trial. PLoS One. 2012;7(3):e32894. doi: 10.1371/journal.pone.0032894. Epub 2012 Mar 28.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
002
Identifier Type: -
Identifier Source: org_study_id