Clinical trial NCT03532620: China Protection Trial of Glucose Metabolism by Pitavastatin in Patients With Prediabetes and Hypertension
Official title: A Multi-center, Open-label, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Hemoglobin A1C Metabolism of Pitavastatin Therapy Versus Atorvastatin in Chinese Patients With Prediabetes and Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prediabetic State
Hypertension
Dyslipidemias
Keywords: Pitavastatin
Prediabetic State
Hypertension
Dyslipidemias
Cardiovascular Disease
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2018-05-22
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. Age 18-80 years old;
2. IFG: 5.6mmol/L (100mg/dl)≤FPG\<7.0mmol/L (126mg/dl), or IGT: 7.8mmol/L (140mg/dl)≤OGTT 2-h PG\<11.1mmol/L (200mg/dl), or HbA1C 5.7-6.4% (39-47mmol/mol);
3. 2.6mmol/L (100mg/dl)≤LDL-C≤5.2mmol/L (200mg/dl), and TG\<5.7mmol/L (500mg/dl);
4. 130mmHg≤SBP\<180mmHg, or 80mmHg≤DBP\<110mmHg or ongoing anti-hypertensive therapy;
5. Patients volunteered for the study and signed informed consent.

Exclusion Criteria:

1. Past history of hypersensitivity to the study drug;
2. Diagnosed diabetes;
3. Severe liver disease (including ALT or AST≥2.5-fold the normal upper limit), biliary obstruction;
4. Ongoing treatment with cyclosporine within 2 weeks;
5. Renal dysfunction, including endogenous creatinine clearance male\<120ml/min, female\<105ml/min, serum creatinine≥2mg/dl (186umol/L), Renal function progressive decline, GFR\<30ml•min-1•1.73m-2;
6. Diagnosed or past history of ASCVD (including ACS, SCAD, revascularization, ICM, ischemic stroke, TIA, PASD, etc.
7. SBP≥180mmHg, or DBP≥110mmHg;
8. Ongoing treatment with Beta blockers, Diuretic;
9. Secondary hypertension, including SAS, PA, RAS, pheochromocytoma, Cushing's syndrome, aorta diseases, drug induced hypertension;
10. Ongoing treatment with statins, fibrates, and/or cation exchange resins within 2 weeks;
11. Pancreatic disease;
12. History of gastrectomy, short bowel syndrome;
13. Ongoing hormone replacement therapy;
14. Diagnosed or suspected malignant tumor;
15. Familial hypercholesterolemia;
16. Any diseases may limit the efficacy or safety of the study;
17. Pregnant or possibly pregnant woman, or breastfeeding woman, or woman who wishes to become pregnant during study participation;
18. Patient who was not judged as eligible by the investigator/coinvestigator.

    * IFG impaired fast glucose, FPG fasting plasma glucose, IGT impaired glucose tolerance, OGTT oral glucose tolerance test, PG plasma glucose, HbA1C hemoglobin A1C, LDL-C low-density lipoprotein cholesterol, TG triglycerides, SBP systolic blood pressure, DBP diastolic blood pressure, ALT alanine aminotransferase, AST aspartate aminotransferase, GFR glomerular filtration rate, ASCVD arteriosclerotic cardiovascular disease, ACS acute coronary syndrome, SCAD stable coronary artery disease, ICM ischemic cardiomyopathy, TIA transient ischemic attack, PASD peripheral atherosclerotic disease, SAS sleep apnea syndrome, PA primary aldosteronism, RAS renal arterial stenosis

Primary outcomes:
measure: Change from baseline in hemoglobin A1c levels
timeFrame: Month 12
Secondary outcomes:
measure: Changes from baseline in FPG levels
timeFrame: Month 12
measure: Changes from baseline in OGTT-2h PG levels
timeFrame: Month 12
measure: Proportion of subjects in LDL-C normalization state
timeFrame: Month 3 and 12
measure: Changes from baseline in high-density lipoprotein cholesterol (HDL-C) levels
timeFrame: Month 12
measure: Changes from baseline in total cholesterol (TC) levels
timeFrame: Month 12
measure: Changes from baseline in triglycerides (TG) levels
timeFrame: Month 12
measure: Changes from baseline in inflammatory parameters
timeFrame: Month 12
measure: Incidence of cardiovascular disease (CVD) events
timeFrame: Month 12
measure: Change from baseline in blood pressure levels
timeFrame: Month 12
measure: Changes from baseline in vascular endothelial function
timeFrame: Month 12
measure: Changes from baseline in left ventricular mass index
timeFrame: Month 12
measure: Changes from baseline in carotid intima-media thickness
timeFrame: Month 12
Other outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Month 12
Locations:
city: Chongqing
country: China
facility: Fourth People's Hospital of Chongqing
state: Chongqing
city: Guangzhou
country: China
facility: First Affiliated Hospital,Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: First Affiliated Hospital of Jinan University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Zhongshan
country: China
facility: People's Hospital of Zhongshan City
state: Guangdong
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Yichang
country: China
facility: Yichang Central Hospital
state: Hubei
city: Taizhou
country: China
facility: Taizhou Hospital of TCM
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Subei People's Hospital of Jiangsu province
state: Jiangsu
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Qinghai
city: Yantai
country: China
facility: Yantaishan Hospital, Yantai
state: Shandong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Jun Tao, MD,PhD
role: STUDY_CHAIR
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