Clinical trial: Evolocumab Plus Ezetimibe in Haemodialized Statin-intolerant Patients With Hypercholesterolemia (NCT04659525)

Eligibility criteria:
Inclusion Criteria:

          -  high cardiovascular risk defined as patients with: Documented cardiovascular disease
             (CVD), clinical or unequivocal on imaging. Documented clinical CVD includes previous
             acute myocardial infarction, coronary revascularization and other arterial
             revascularization procedures, stroke and TIA, aortic aneurysm and PAD. Unequivocally
             documented CVD on imaging includes plaque on coronary angiography or carotid
             ultrasound; DM with target organ damage or with a major risk factor such as smoking or
             marked hypercholesterolaemia or marked hypertension.

          -  History of statin intolerance, demonstrated by: trial of ≥2 statins with intolerance
             of any dose or to increase statin dose above the total maximum doses because of
             intolerable: Myopathy or myalgia (muscle pain, ache, or weakness without CK
             elevation), or Myositis (muscle symptoms with increased CK levels), or Rhabdomyolysis
             (muscle symptoms with marked CK elevation) and Resolution or improvement of symptoms
             when the statin dose was decreased or discontinued

          -  patients with LDL-C >55 mg/dL

          -  end-stage renal disease on chronic hemodialysis

          -  Participant is willing and able to give informed consent for participation in the
             study.

        Exclusion Criteria:

          -  secondary hypercholesterolemia (i.e. hypothyroidism, Primary biliary cholangitis, etc)

          -  Use of drugs or dietary supplements that can impact on cholesterol value (i.e.
             progestinic, red yeast rice, niacin >200 mg/d, lipid-regulating drugs - eg, ﬁbrates or
             derivatives, ezetimibe, bile-acid sequestrants, stanols, or stanol esters - )

          -  Previous treatment with evolocumab or any other anti-PCSK9 therapy

          -  Inability to provide informed consent or to attend follow-up visits

          -  Unreliability as a study participant based on judgment of investigator's knowledge of
             the subject (eg, alcohol or other drug abuse, inability or unwillingness to adhere to
             the protocol, psychosis)

          -  Current enrollment in another investigational device or drug study or <30 d since
             ending another investigational device or drug study

          -  serum triglycerides level > 400 mg/dL at baseline

          -  Pregnancy, breastfeeding, or inadequate birth control in premenopausal female subjects

          -  Laboratory values at screening CK >3 × ULN; AST or ALT >2 × ULN
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Contradiction