China Protection Trial of Glucose Metabolism by Pitavastatin in Patients With Prediabetes and Hypertension

Phase 4

• Conditions: Prediabetic State; Hypertension; Dyslipidemias
• Interventions: Drug: Atorvastatin Calcium; Drug: Pitavastatin Calcium

• Registration Number: NCT03532620
• Lead Sponsor: Jun Tao

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).

Study Timeline

• Study First Submitted: 2018-04-27
• Study First Submitted QC: 2018-05-10
• Study First Posted: 2018-05-22
• Study Start: 2018-08-09
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-31
• Last Update Posted: 2019-06-03
• Primary Completion: 2019-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 396

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atorvastatin	Atorvastatin Calcium	Atorvastatin Calcium + lifestyle modification
pitavastatin	Pitavastatin Calcium	Pitavastatin Calcium + lifestyle modification

Primary Outcome Measures

Name	Time	Method
Change from baseline in hemoglobin A1c levels	Month 12	Change of HbA1C values at study initiation and study completion

Secondary Outcome Measures

Name	Time	Method
Change from baseline in blood pressure levels	Month 12	Change from baseline in systolic and diastolic blood pressure levels
Changes from baseline in vascular endothelial function	Month 12	Change of brachial-ankle pulse wave velocity (baPWV) values at study initiation and study completion
Changes from baseline in OGTT-2h PG levels	Month 12	Change of oral glucose tolerance test (OGTT)-2h plasma glucose (PG) values at study initiation and study completion
Proportion of subjects in LDL-C normalization state	Month 3 and 12	Proportion of subjects in each group who achieved low-density lipoprotein cholesterol (LDL-C) target
Changes from baseline in high-density lipoprotein cholesterol (HDL-C) levels	Month 12	Change of HDL-C values at study initiation and study completion
Changes from baseline in triglycerides (TG) levels	Month 12	Change of TG values at study initiation and study completion
Changes from baseline in FPG levels	Month 12	Change of fasting plasma glucose (FPG) values at study initiation and study completion
Changes from baseline in total cholesterol (TC) levels	Month 12	Change of TC values at study initiation and study completion
Changes from baseline in inflammatory parameters	Month 12	Change of C-reactive protein (CRP) values at study initiation and study completion
Changes from baseline in left ventricular mass index	Month 12	Change of left ventricular mass index (LVMI) values at study initiation and study completion
Incidence of cardiovascular disease (CVD) events	Month 12	Incidence of cardiovascular disease (CVD) events, including acute coronary syndrome, stable coronary artery disease, ischemic cardiomyopathy etc.
Changes from baseline in carotid intima-media thickness	Month 12	Change of carotid intima-media thickness (CIMT) values at study initiation and study completion

Trial Locations

Locations (13)

First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Fourth People's Hospital of Chongqing; 🇨🇳 Chongqing, Chongqing, China

First Affiliated Hospital,Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

First Affiliated Hospital of Jinan University; 🇨🇳 Guangzhou, Guangdong, China

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

People's Hospital of Zhongshan City; 🇨🇳 Zhongshan, Guangdong, China

Yichang Central Hospital; 🇨🇳 Yichang, Hubei, China

Taizhou Hospital of TCM; 🇨🇳 Taizhou, Jiangsu, China

Wuxi People's Hospital; 🇨🇳 Wuxi, Jiangsu, China

Subei People's Hospital of Jiangsu province; 🇨🇳 Yangzhou, Jiangsu, China

Lanzhou University Second Hospital; 🇨🇳 Lanzhou, Qinghai, China

Yantaishan Hospital, Yantai; 🇨🇳 Yantai, Shandong, China