Atherosclerosis cardiovascular disease
Conditions
Interventions
Subjects completing study MDCO-PCS-15-01 and fulfilling all inclusion and
exclusion criteria of this study will receive inclisiran or evolocumab, based
on the treatment received in study MDCO-PCS-15
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Completion of study MDCO-PCS-15-01 and no contraindications to receiving inclisiran or evolucumab. 2. Willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures. 3. Willing to self-inject
Exclusion criteria
Exclusion criteria: 1. Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the subject at significant risk (according to investigator*s [or delegate*s] judgment) if he/she participates in the clinical study. 2. An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results. 3. Serious comorbid disease in which the life expectancy of the subject is shorter than the duration of the trial (eg, acute systemic infection, cancer, or other serious illnesses). 4. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST), elevation >2x the upper limit of normal (ULN), or total bilirubin elevation >1.5x ULN at study entry visit, confirmed by a repeat abnormal measurement at least 1 week apart. 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least two methods of contraception (eg, oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device) for the entire duration of the study. Exemptions from this criterion: a. Women >2 years postmenopausal (defined as 1 year or longer since their last menstrual period) AND more than 55 years of age b. Postmenopausal women (as defined above) and less than 55 years old with a negative pregnancy test within 24 hours of enrollment c. Women who are surgically sterilized at least 3 months prior to enrollment 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide). 7. Treatment with investigational medicinal products other than inclisiranor devices within 30 days or five half*lives, whichever is longer. 8. Planned use of other investigational medicinal products other than inclisiranor devices during the course of the study. 9. Subjects with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients. 10. Previous or current treatment (within 90 days of study entry) with monoclonal antibodies directed towards PCSK9. 11. Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to: a. Inappropriate for this study, including subjects who are unable to communicate or to cooperate with the investigator. b. Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including subjects whose cooperation is doubtful due to drug abuse or alcohol dependency). c. Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (eg, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study). d. Involved with, or a relative of, someone directly involved in the conduct of the study. e. Any known cognitive impairment (eg, Alzheimer*s disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parameters to be assessed will include: total cholesterol (TC), triglycerides, LDL-C, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, very low-density lipoprotein (VLDL), apolipoprotein A1 (Apo-AI), apolipoprotein B (Apo-B), lipoprotein(a) [Lp(a)], C-reactive protein (CRP), and PCSK9. | — |
Countries
Netherlands
Outcome results
None listed