This trial is completed!
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You can access this
clinical trial
if you have
Type 2 Diabetes Mellitus, Atherosclerosis or Dyslipidemia
and you are
between 35 and 80
years old
Phase
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The purpose

Statins are commonly prescribed to lower cardiovascular risk in primary and secondary prevention. Despite their well known efficacy, statin withdrawal is a common event. Even a short term statin withdrawal can have dramatic consequences on atherosclerotic plaque stability, owing to a rebound in cholesterol levels and inflammation. The effects of a short term statin withdrawal on endothelial progenitor cells (EPC) and monocyte/macrophage polarization is unknown. In this study, the investigators will explore the effects of a 5-day statin withdrawal on EPC and monocyte/macrophage polarization, together with other inflammatory biomarkers in type 2 diabetic patients. The investigators hypothesize that statin withdrawal determines a reduction in EPC levels and an inflammatory cell polarization. Patients will be randomized to continue their habitual statin regimen or to withdraw statin. At baseline and 5 days later, blood samples will be collected for experimental measures.

Provided treatments

  • Other: Statin withdrawal
Tris trial is registered with FDA with number: NCT01600690. The sponsor of the trial is University of Padova and it is looking for 34 volunteers for the current phase.
Official trial title:
Evaluation of the Effects of 5-day Statin Withdrawal on Endothelial Progenitor Cells and Inflammatory Markers in Type 2 Diabetic Patients. A Controlled Randomized Study