PRINCESS: Prevention of Re-Infarction by early treatment with CerivaStatin-Study Principal Investigators:

Principal Investigators:

Chaim Lotan MD, MD Mark Papoff MD, A.Teddy Weiss MD, David Leibowitz MD

Sponsor:

Bayer, Germany

Monitor

Pharma Clinical

Abstract

This study will investigate whether early acute treatment with cerivastatin after a myocardial infarct (MI), regardless of lipid levels, reduces the incidence of cardiovascular morbidity and mortality.

The primary object of the study is the reduction of cardiovascular morbidity and mortality at two years. The secondary objectives are 1. the reduction of cardiovascular morbidity and mortality at 3 months and at 1 year; 2. the effect on inflammation markers and 3. the change on lipid parameters.

It is conceived as a multinational, multi-center, randomized, placebo-controlled, parallel-group study to compare the effect of cerivastatin 0.4mg od vs placebo in acute treatment of patients after MI during 3 months, followed by a period of 21 month-treatment with cerivastatin 0.4mg od in both groups.

Status

Trial stopped.