Efficacy and safety of Evoluocumab added Standard of Care in high cardiovascular risk haemodialized statin intolerant patients with hypercholesterolemia.
- Conditions
- High cardiovascular risk haemodialized statin intolerant patients with hypercholesterolemia.MedDRA version: 20.0Level: HLGTClassification code 10013317Term: Lipid metabolism disordersSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 20.0Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: SOCClassification code 10047065Term: Vascular disordersSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2019-001491-11-IT
- Lead Sponsor
- IRCCS SAN RAFFAELE PISANA GESTITO DA SAN RAFFAELE ROMA SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Patients will be included in the study if all of the following criteria are met:
- Age = 18; both genders.
- High cardiovascular risk patients defined as: patients with established coronary heart disease (CHD), OR patients with CHD risk equivalents (ischemic stroke, peripheral artery disease, diabetes mellitus plus at least 2 additional risk factors);
- Statin-intolerant patients with not adequately controlled LDL-C levels (=70 mg/dL)
- Patients with uremia on periodic haemodialysis treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
- LDL-C <70 mg/dL
- Age < 18 years.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method