Rosuvastatin Adherence App Study in China (eHELP China)

This is an interventional supportive care trial for Dyslipidemia focused on measuring smart phone-based, rosuvastatin, duration of treatment, Treatment adherence Read More

Inclusion Criteria:

• Provision of informed consent prior to any study specific procedures
• Female or male aged 18-80 years, diagnosed with dyslipidemia or hyperlipidemia at high risk and prescribed rosuvastatin

Dyslipidemia or hyperlipidemia defined as:

LDL-C≥2.6 mmol/L and TG<4.52mmol/L

High risk complies with any of the following:

• Documented cardiovascular disease (CVD) by invasive or non-invasive testing (such as coronary angiography, nuclear imaging, stress echocardiography, carotid plaque on ultrasound), previous myocardial infarction (MI), acute coronary syndrome (ACS), coronary revascularization [percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)] and other arterial revascularization procedures, ischaemic stroke and peripheral arterial disease (PAD).
• Patients with type 2 diabetes, patients with type 1 diabetes with target organ damage (such as microalbuminuria).

• Patients with moderate to severe chronic kidney disease [(CKD), glomerular filtration rate (GFR) < 60 mL/min/1.73 m2].

  • Patients must have a smart phone that is compatible with the patient support tool and clinical evaluation questionnaire at their disposal and are comfortable with using of interactive smart phone applications. The required specification for the phone will be determined after completed testing.
  • Ability to read, understand and write Chinese.
  • Statin-naïve or with no statin use during the last 4 weeks prior to enrolment except in the event of patients may receive at most 7 doses of statins during current hospitalization before enrollment.

Exclusion Criteria:

• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
• Previous enrolment or randomisation in the present study
• Participation in another clinical study with an investigational product or device during the last 30 days excluding prospective/retrospective register based studies that do not require any extra visits in addition to ordinary health care. Patients who withdraw from this study for any reason cannot re-enter the study.

• Patients in whom rosuvastatin is contraindicated i.e.

  • patients with hypersensitivity to rosuvastatin or any of the excipients.
  • patients with active liver disease including unexplained, persistent elevations of serum transaminases and have serum transaminase elevation exceeding 3 x the upper limit of normal (ULN).
  • patients with severe renal impairment (creatinine clearance <30 ml/min).
  • patients with myopathy.
  • patients receiving concomitant cyclosporin.
  • females during pregnancy and lactation and women of childbearing potential who are not using appropriate contraceptive measures.
• Significant medical or psychological condition that, in the opinion of the Investigator, would compromise the patient's safety or successful participation in the study.