Diagnosis and Therapy of Vulnerable Atherosclerotic Plaque

Completed

Phase N/A Results N/A

Trial Description

The aim of the present study is to examine the atherosclerotic plaque stability using in vivo and in vitro techniques and to investigate the influence of exercise, anti-diabetic, lipid-lowering and cannabinoids receptor antagonists on atherosclerotic plaque texture in patients with cardiovascular risk and animals prone to atherosclerosis.

Conditions

Interventions

  • Atorvastatin (LipitorĀ®)Drug
    Other Names: Lipitor
    Intervention Desc: A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)
    ARM 1: Kind: Experimental
    Label: 1
  • Rimonabant Drug
    Other Names: SR141716; Acomplia
    Intervention Desc: A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)
    ARM 1: Kind: Experimental
    Label: 1
  • Rosiglitazone Drug
    Intervention Desc: A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)
    ARM 1: Kind: Experimental
    Label: 1
  • Metformin Drug
    Intervention Desc: A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)
    ARM 1: Kind: Experimental
    Label: 1

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Endpoint: Efficacy Study
  • Intervention: Factorial Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Ultrasound and immunohistochemical parameters of plaque stability; novel cardiovascular risk factors 3 years Yes
Secondary Long-term cardiovascular outcomes 3 years Yes

Sponsors