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Rosuvastatin combined with ezetimibe in patients at high risk for cardiovascular safety and efficacy evaluation of combined hepatitis B virus carriers

Rosuvastatin combined with ezetimibe in patients at high risk for cardiovascular safety and efficacy evaluation of combined hepatitis B virus carriers

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14005056
Enrollment
Unknown
Registered
2014-07-21
Start date
2014-08-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBV carriers with cardiovascular risk factors in patients with lipid-lowering therapy

Interventions

Sponsors

Second Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-80 years old, male or female; 2. test positive for hepatitis B infection markers: surface antigen (HBsAg); 3. According 2013ACC/AHA lipid guidelines recommend the use of lipid-lowering statin therapy with either one of the following situations: (1) patients with clinical atherosclerotic cardiovascular disease (ASCVD) is; (2) LDL-C more than 190mg/dL, including familial hypercholesterolemia patients; (3) diabetic patients, aged 40-75 years old, LDL-C between 70-189mg/dL, merge or do not merge arteriosclerotic cardiovascular disease evidence; (4) no evidence of cardiovascular disease or diabetes, but LDL-C, and between 70-189mg/dL atherosclerotic cardiovascular disease more than 7.5% 10-year risk patients.

Exclusion criteria

Exclusion criteria: 1. ALT more than 3xULN; 2. hepatitis B virus activity and require antiretroviral therapy (HBV-DNA more than 105 copies/ml and HBVe negative patients HBV-DNA more than 104 copies/ml); 3. decompensated cirrhosis; 4. combined with other types of hepatitis; 5. severe renal insufficiency; 6. myopathy or myositis patients and statin use contraindicated in patients; 7. ezetimibe contraindicated in patients.

Design outcomes

Primary

MeasureTime frame
ALT;AST;CK-MB;CK;LDH;Gama-GT;BUN;Ccr;MACE events (new-onset atrial fibrillation, myocardial infarction, unstable angina, heart failure, etc.);HBV-DNA;

Secondary

MeasureTime frame
TC;TG;LDL-C;

Countries

China

Contacts

Public ContactQiang She
qshe@hotmail.com+86 13508393602

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026