SAFE-CRP: Structural Alterations and Function of Endothelium in Cardiovascular Risk Patients

Methodology: 2:1 randomised, double-blind and placebo-controlled parallel-group design Planned/actual number of subjects: Enrolled: 30/33, randomised: 30/22, completed: 30/15 Duration of treatment: 9 months: telmisartan (80 mg) or Placebo (80 mg) Study Hypothesis: The trial is designed as a group comparison of telmisartan 80 mg and placebo, where the treatment groups are randomised in 2:1 relation, to investigate the efficacy of telmisartan on structural alterations and endothelial dysfunction as measured as the percentage change from baseline after 36 weeks of treatment of the atheroma volume in the femoral artery using IVUS . Secondary endpoints are the changes from baseline in the flow dependent dilatation after a acetylcholine challenge which follows a nitro-glycerin bolus, the change of the total atheroma volume, the percentage atheroma volume measured by intravascular ultrasound (IVUS) and the infalmmatory parameters MCP-1, CRP, ox LDL antibodies and sPLA2 activity and amount. In an analysis of covariance using baseline as covariate all endpoints will be investigated. If the assumptions of normal distribution are not fulfilled, nonparametric methods will be applied (Wilcoxon-Mann-Whitney test). Comparison(s): Placebo 80 mg