A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY TO EVALUATE CARDIOVASCULAR OUTCOMES DURING TREATMENT WITH LIXISENATIDE IN TYPE 2 DIABETIC PATIENTS AFTER AN ACUTE CORONARY SYNDROME EVENT

Sanofi-Aventis del Peru S.A.,0 个研究点目标入组 107 人开始时间: 2012年9月6日最近更新: 2023年9月4日

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•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.

•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.

发起方

Sanofi-Aventis del Peru S.A.,