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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00636766
Other study ID # 887/2005
Secondary ID
Status Completed
Phase N/A
First received March 11, 2008
Last updated November 1, 2012
Start date September 2005
Est. completion date January 2009

Study information

Verified date November 2012
Source Aristotle University Of Thessaloniki
Contact n/a
Is FDA regulated No
Health authority Greece: National Organization of Medicines
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date January 2009
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria:

- Carotid atherosclerosis

- Femoral atherosclerosis

- Cardiovascular risk

Exclusion Criteria:

- Heart failure

- Renal disease

- Liver disease

- Life-threatening diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label


Intervention

Drug:
atorvastatin
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)
rimonabant
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)
rosiglitazone
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)
metformin
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)

Locations

Country Name City State
Greece General Hospital of Thessaloniki "Hippokratio" Thessaloniki

Sponsors (1)

Lead Sponsor Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description 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
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