The primary purpose of this trial is to test the hypothesis that Pitavastatin treatment compared to Atorvastatin, in patients with dyslipidemia, prediabetes and hypertension, will have less adverse effect on Hemoglobin A1C (HbA1C), which represents long-term glucose metabolism.
Within the 12 months of the study procedure, the 3rd month is what we called the "check point". At this point, participants' plasma LDL-C will be measured whether it reached individual standard or not. If the results didn't meet the particular LDL-C standard, the participants would be adjusted the drug dosage (pitavastatin 4mg/day, atorvastatin 40mg/day).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
396
In Pitavastatin treatment group, Pitavastatin calcium tablet 2mg/day was given for 12 months in combination with lifestyle modification. But month 3 is the "check point". If LDL-C target was achieved at Month 3, doses remained the same. If LDL-C target was not achieved at Month 3, doses were doubled.
In Atorvastatin treatment group, Atorvastatin calcium tablet 20mg/day was given for 12 months in combination with lifestyle modification. But month 3 is the "check point". If LDL-C target was achieved at Month 3, doses remained the same. If LDL-C target was not achieved at Month 3, doses were doubled.
Fourth People's Hospital of Chongqing
Chongqing, Chongqing Municipality, China
RECRUITINGFirst Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China
Change from baseline in hemoglobin A1c levels
Change of HbA1C values at study initiation and study completion
Time frame: Month 12
Changes from baseline in FPG levels
Change of fasting plasma glucose (FPG) values at study initiation and study completion
Time frame: Month 12
Changes from baseline in OGTT-2h PG levels
Change of oral glucose tolerance test (OGTT)-2h plasma glucose (PG) values at study initiation and study completion
Time frame: Month 12
Proportion of subjects in LDL-C normalization state
Proportion of subjects in each group who achieved low-density lipoprotein cholesterol (LDL-C) target
Time frame: Month 3 and 12
Changes from baseline in high-density lipoprotein cholesterol (HDL-C) levels
Change of HDL-C values at study initiation and study completion
Time frame: Month 12
Changes from baseline in total cholesterol (TC) levels
Change of TC values at study initiation and study completion
Time frame: Month 12
Changes from baseline in triglycerides (TG) levels
Change of TG values at study initiation and study completion
Time frame: Month 12
Changes from baseline in inflammatory parameters
Change of C-reactive protein (CRP) values at study initiation and study completion
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Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGFirst Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
RECRUITINGShenzhen People's Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGPeople's Hospital of Zhongshan City
Zhongshan, Guangdong, China
RECRUITINGFirst Affiliated Hospital of Zhengzhou University
Zhengzhou, He'nan, China
RECRUITINGYichang Central Hospital
Yichang, Hubei, China
RECRUITINGTaizhou Hospital of TCM
Taizhou, Jiangsu, China
RECRUITINGWuxi People's Hospital
Wuxi, Jiangsu, China
RECRUITING...and 3 more locations
Time frame: Month 12
Incidence of cardiovascular disease (CVD) events
Incidence of cardiovascular disease (CVD) events, including acute coronary syndrome, stable coronary artery disease, ischemic cardiomyopathy etc.
Time frame: Month 12
Change from baseline in blood pressure levels
Change from baseline in systolic and diastolic blood pressure levels
Time frame: Month 12
Changes from baseline in vascular endothelial function
Change of brachial-ankle pulse wave velocity (baPWV) values at study initiation and study completion
Time frame: Month 12
Changes from baseline in left ventricular mass index
Change of left ventricular mass index (LVMI) values at study initiation and study completion
Time frame: Month 12
Changes from baseline in carotid intima-media thickness
Change of carotid intima-media thickness (CIMT) values at study initiation and study completion
Time frame: Month 12