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Aspirin Statins Or Both For The Reduction Of Thrombin Generation In Diabetic People

NCT00793754 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-10-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Aspirin

100 mg / day for 8 weeks

DRUG

Atorvastatin

40 mg / day for 8 weeks

DRUG

Aspirin + Atorvastatin

Aspirin 100 mg / day + Atorvastatin 40 mg / day for 8 weeks

Sponsors & Collaborators

  • Fundacion GESICA

    lead OTHER

Principal Investigators

  • Alejandro Macchia, MD · Fundacion GESICA

  • Hernan Doval, MD · Fundacion GESICA

  • Juan J Fuselli, MD · Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

  • Pablo D Comignani, MD · Hospital Aleman

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00793754 on ClinicalTrials.gov