Acupuncture and Moxibustion for Hyperlipemia (AMH-RCT)

This is an interventional treatment trial for Hyperlipidemias focused on measuring acupuncture, moxibustion, hyperlipidemias, effectiveness Read More

Inclusion Criteria:

• Subject signed the informed consent
• Male or female ≥18 to ≤75 years of age
• Fasting TG ≤400 mg/dL

• Fasting LDL-C as determined by central laboratory on admission and meeting the following LDL-C values based on risk factor status:

  • 0-1 Risk Factor Group: LDL-C ≥160 mg/dL
  • 2+ Risk Factor Group: LDL-C ≥130 mg/dL
  • CHD or CHD risk equivalents: LDL-C ≥100 mg/dL
  • Major Risk factors: （1）Cigarette smoking;（2）Hypertension (BP ≥140/90 mmHg or on anti-hypertensive medication);（3）Low HDL cholesterol (HDL-C <40 mg/dL);（4）Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years);（5）Age (men ≥45 years; women ≥55 years)
  • CHD and CHD equivalents:（1）Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease);（2）Diabetes;（3）Multiple risk factors that confer a 10-year risk for CHD >20%

Exclusion Criteria:

• CHD or CHD risk equivalent and not receiving statin therapy, with LDL-C at screening ≤99 mg/dL
• NYHA II, III or IV heart failure, or last known left ventricular ejection fraction <30%
• Uncontrolled cardiac arrhythmia, atrial fibrillation with rapid ventricular response, or not controlled supraventricular tachycardia in the past 3 months prior to randomization
• Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
• Planned cardiac surgery or revascularization
• Type 1 diabetes or newly diagnosed type 2 diabetes or poorly controlled type 2 diabetes
• Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) >160 mmHg or diastolic BP (DBP) >100 mmHg
• Subjects taken red yeast rice, niacin >200 mg/d, or omega-3 fatty acids >1000 mg/d or prescription lipid-regulating drugs other than statins or ezetimibe, such as fibrates and derivatives, or bile-acid sequestering resins in the last 6 weeks prior to LDL-C screening
• Subjects taken systemic cyclosporine, systemic steroids, vitamin A derivatives and retinol derivatives for the treatment of dermatologic conditions in the last 3 months prior to LDL-C screening
• Hyperthyroidism or hypothyroidism
• Moderate to severe renal dysfunction
• Active liver disease or hepatic dysfunction
• CK >3 times the ULN at screening or at end of lipid stabilization period, confirmed by a repeat measurement at least 1 week apart
• Known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator
• Deep vein thrombosis or pulmonary embolism within 3 months prior to randomization
• Current therapeutic anticoagulation with vitamin K antagonist, heparin, low-molecular weight heparin, direct thrombin inhibitor
• Currently enrolled in another investigational device or drug study
• Female subject during pregnant or breast feeding period
• History of malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma)
• Known sensitivity to any of the products to be administered during dosing
• Subjects couldn't provide the written informed consent and/or comply with all required study procedures