None listed
Conditions
Interventions
THE INDEX QUALIFYING MI MUST HAVE OCCURRED AT LEAST 30 DAYS PRIOR TO RANDOMIZATION. THERE IS NO UPPER LIMIT FOR POST-MI FOR INCLUSION IN TO THE STUDY. STANDARD OF CARE POST-MI BACKGROUND THERAPY INCLU
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. WRITTEN INFORMED CONSENT MUST BE OBTAINED BEFORE ANY ASSESSMENT IS PERFORMED. 2. MALE, OR FEMALE OFNON-CHILD-BEARING POTENTIAL 3. AGE ≥ 18 YEARS AT VISIT 1. 4. DOCUMENTED SPONTANEOUS MI (DIAGNOSED ACCORDING TO THE UNIVERSAL MI CRITERIA WITH OR WITHOUT EVIDENCE OF ST SEGMENT ELEVATION) AT LEAST 30 DAYS BEFORE RANDOMIZATION. (THYGESEN ET AL 2007) • DIAGNOSIS OF PRIOR MI SHOULD BE BASED ON MEDICAL HISTORY OF CLINICAL SYMPTOMS CONSISTENT WITH MYOCARDIAL ISCHEMIA ASSOCIATED WITH ELEVATION OF CARDIAC BIOMARKERS ABOVE THE 99TH PERCENTILE OF THE UPPER REFERENCE LIMIT (PREFERABLY TROPONIN) OR DEVELOPMENT OF NEW PATHOLOGICAL Q WAVES REGARDLESS OF SYMPTOMS. FOR DETAILS, REFER TO THE UNIVERSAL DEFINITION OF MI (THYGESEN ET AL 2007). PLEASE SEE BEL0W FOR DOCUMENTATION REQUIREMENTS. A. ACUTE MI (HOSPITALIZATION RECORDS): REQUIRES DOCUMENTATION OF A RISE AND/OR FALL OF CARDIAC BIOMARKERS (PREFERABLY TROPONIN) WITH AT LEAST ONE VALUE ABOVE THE 99TH PERCENTILE OF THE UPPER REFERENCE LIMIT (URL) OR ABOVE CRITERIA DIAGNOSTIC FOR MI AND EVIDENCE OF MYOCARDIAL ISCHEMIA AS DEMONSTRATED BY AT LEAST ONE OF THE FOLLOWING: I. SYMPTOMS OF ISCHEMIA
Exclusion criteria
Exclusion criteria: 1. PREGNANT OR NURSING (LACTATING) WOMEN, WHERE PREGNANCY IS DEFINED AS THE STATE OF A FEMALE AFTER CONCEPTION AND UNTIL THE TERMINATION OF GESTATION, CONFIRMED BY A POSITIVE HCG LABORATORY TEST 2. WOMEN OF CHILD-BEARING POTENTIAL, DEFINED AS ALL WOMEN PHYSIOLOGICALLY CAPABLE OF BECOMING PREGNANT, UNLESS THEY ARE A. WOMEN ARE CONSIDERED POST-MENOPAUSAL AND NOT OF CHILD BEARING POTENTIAL IF THEY HAVE HAD 12 MONTHS OF NATURAL (SPONTANEOUS) AMENORRHEA WITH AN APPROPRIATE CLINICAL PROFILE (E.G. AGE APPROPRIATE, HISTORY OF VASOMOTOR SYMPTOMS) OR HAVE HAD SURGICAL BILATERAL OOPHORECTOMY (WITH OR WITHOUT HYSTERECTOMY) OR TUBAL LIGATION AT LEAST SIX WEEKS AGO. IN THE CASE OF OOPHORECTOMY ALONE OR PARTIAL OR TOTAL HYSTERECTOMY, ONLY WHEN THE REPRODUCTIVE STATUS OF THE WOMAN HAS BEEN CONFIRMED BY FOLLOW UP HORMONE LEVEL ASSESSMENT IS SHE CONSIDERED NOT OF CHILD BEARING POTENTIAL. 3. ANY OF THE FOLLOWING CONCOMITANT CONDITIONS OR DISEASES: A. PLANNED CORONARY REVASCULARIZATION (PCI OR CABG) OR ANY OTHER MAJOR SURGICAL PROCEDURE. B. MAJOR NON-CARDIAC SURGICAL OR ENDOSCOPIC PROCEDURE WITHIN PAST 6 MONTHS TO VISIT 1 C. MULTI-VESSEL CABG SURGERY WITHIN THE PAST 3 YEARS
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Ecuador, Estonia, Germany, Greece, Guatemala, Hungary, Iceland, India, Israel, Italy, Japan, Korea North, Lithuania, Mexico, Netherlands, Norway, Poland, Romania, Russian Federation, Slovakia, Slovenia, South Africa, Sweden, Switzerland, Taiwan, Turkey, United Kindgdom, United States
Contacts
Public ContactGustavo Toribio
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed