None listed
Conditions
Interventions
THE STUDY WILL COMPRISE 3 PERIODS:
• A PLACEBO RUN-IN PERIOD OF 7 DAYS (+ 3 DAYS) THAT WILL START BY A SCREENING VISIT AT WHICH PATIENTS WILL BE EVALUATED FOR ELIGIBILITY TO ENTER THE RUN-IN PERIOD
ASSUMING 37-MONTH RECRUITMENT PERIOD, AND A MINIMUM OF 10 MONTHS OF FURTHER FOLLOW-UP FOR THE LAST RANDOMIZED PATIENT.
• A POST-TREATMENT SAFETY FOLLOW-UP PERIOD OF 3 DAYS (± I DAY), ONLY FOR PATIE
Sponsors
Sanofi-Aventis del Peru S.A.,
Eligibility
Sex/Gender
All
Age
30 Years to 90 Years
Inclusion criteria
Inclusion criteria: 101A3. MEN AND WOMEN WHO EXPERIENCED A SPONTANEOUS, ACUTE CORONARY SYNDROME (ACS) EVENT (IE., ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION [STEMI] OR NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION [NSTEMI] OR UNSTABLE ANGINA [USA]) WITH THE FOLLOWING REQUIREMENTS: . THERE MUST HAVE BEEN A DOCUMENTED ELEVATION ABOVE THE NORMAL REFERENCE RANGE OF A CARDIAC BIOMARKER (TROPONIN OR CK-MB), AND . THE PRESENTATION OF THE EVENT MUST BE CONSISTENT WITH AN ACUTE CORONARY SYNDROME WHICH LEADS TO ADMISSION TO AN ACUTE CARE FACILITY (EG, ER, CCU, CATH LAB, HOSPITAL). IF THE QUALIFYING ACS EVENT FOLLOWS A REVASCULARIZATION PROCEDURE, IT MUST HAVE OCCURRED MORE THAN 15 DAYS AFTER A PCI AND MORE THAN 45 DAYS AFTER A CABG, AND . PATIENTS SHOULD BE APPROACHED ABOUT THE STUDY AS SOON AS POSSIBLE FOLLOWING THEIR ADMISSION FOR THE QUALIFYING ACS EVENT, INCLUDING SIGNING OF THE INFORMED CONSENT FORM, WHERE PERMITTED BY LOCAL REGULATIONS. HOWEVER, THE SCREENING VISIT MUST OCCUR ONLY AFTER THE PATIENT IS DISCHARGED FROM THE ACUTE CARE FAC I LIT Y, AND MUST TAKE PLACE WITHIN 180 DAYS FOLLOWING THE DATE OF ADMISSION FORTHE QUALIFYING ACS EVENT.
Exclusion criteria
Exclusion criteria: 7.3.1 EXCLUSION CRITERIA RELATED TO STUDY METHODOLOGY EXCLUSION CRITERIA LOR THE ENTRY INTO THE RUN-IN PERIOD E03. AT THE TIME OF SCREENING, AGE < 30 YEARS. E04. W OMEN OF CHILDBEARING POTENTIAL WITH NO EFFECTIVE CONTRACEPTIVE METHOD. WOMEN OF CHILDBEARING POTENTIAL (PRE-MENOPAUSAL, OR WOMEN NOT SURGICALLY STERILE FOR AT LEAST 3 MONTHS PRIOR TO THE TIME OF SCREENING) MUST HAVE A CONFIRMED NEGATIVE SERUM PREGNANCY TEST AT SCREENING VISIT. THEY MUST USE AN EFFECTIVE CONTRACEPTIVE METHOD THROUGHOUT THE STUDY, AND AGREE TO REPEAT SERUM PREGNANCY TEST AT DESIGNATED VISITS. THE APPLIED METHODS OF CONTRACEPTION HAVE TO MEET THE CRITERIA FOR A HIGHLY EFFECTIVE METHOD OF BIRTH CONTROL ACCORDING TO THE NOTE FOR GUIDANCE ON NON-CLINICAL SAFETY STUDIES FOR THE CONDUCT OF HUMAN CLINICAL TRIALS FOR PHARMACEUTICALS (CPMP/ICH/286/95) (30). E05. TYPE 1 DIABETES MELLITUS. E06A3. REQUIRED TO USE INCRETIN-BASED AGENTS (EG, OLP-1 AGONISTS OR DPP-4 INHIBITORS) OTHER THAN THE STUDY DRUG DURIRTG THE DOUBLE-BLIND TREATMENT PERIOD.
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Guatemala, India, Israel, Italy, Japan, Korea North, Lithuania, Mexico, Netherlands, Norway, Panama, Philippines, Poland, Portugal, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kindgdom, United States
Contacts
Public ContactCarola Gisela Guzman
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed