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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion GESICA
• Treatments: Aspirin; Atorvastatin; Atorvastatin Calcium; Thrombin

Criteria

Inclusion Criteria:

• Diabetes mellitus treated with insulin or orl agents

• At least 50 years old

Exclusion Criteria:

• Previous cardiovascular events

• current or past (within last 30 days) treatment with aspirin

• current or past (within last 180 days) treatment with statins