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

NCT03532620 | Unknown Phase 4 DMC

• 1 other identifier: BZ-1702
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 13

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.

Conditions

Prediabetic State; Hypertension; Dyslipidemias

Keywords

Pitavastatin; Prediabetic State; Hypertension; Dyslipidemias; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in hemoglobin A1c levels

  Change of HbA1C values at study initiation and study completion

  Month 12

Secondary Outcomes (12)

• Changes from baseline in FPG levels

  Month 12

• Changes from baseline in OGTT-2h PG levels

  Month 12

• Proportion of subjects in LDL-C normalization state

  Month 3 and 12

• Changes from baseline in high-density lipoprotein cholesterol (HDL-C) levels

  Month 12

• Changes from baseline in total cholesterol (TC) levels

  Month 12

Other Outcomes (1)

• Incidence of adverse events (AEs)

  Month 12

Study Arms (2)

pitavastatin

EXPERIMENTAL

Pitavastatin Calcium + lifestyle modification

Drug: Pitavastatin Calcium

atorvastatin

ACTIVE COMPARATOR

Atorvastatin Calcium + lifestyle modification

Drug: Atorvastatin Calcium

Interventions

Pitavastatin Calcium DRUG

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.

pitavastatin

Atorvastatin Calcium DRUG

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.

Also known as: Lipitor®

atorvastatin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old;
• 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);
• mmol/L (100mg/dl)≤LDL-C≤5.2mmol/L (200mg/dl), and TG\<5.7mmol/L (500mg/dl);
• mmHg≤SBP\<180mmHg, or 80mmHg≤DBP\<110mmHg or ongoing anti-hypertensive therapy;
• Patients volunteered for the study and signed informed consent.

You may not qualify if:

• Past history of hypersensitivity to the study drug;
• Diagnosed diabetes;
• Severe liver disease (including ALT or AST≥2.5-fold the normal upper limit), biliary obstruction;
• Ongoing treatment with cyclosporine within 2 weeks;
• 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;
• Diagnosed or past history of ASCVD (including ACS, SCAD, revascularization, ICM, ischemic stroke, TIA, PASD, etc.
• SBP≥180mmHg, or DBP≥110mmHg;
• Ongoing treatment with Beta blockers, Diuretic;
• Secondary hypertension, including SAS, PA, RAS, pheochromocytoma, Cushing's syndrome, aorta diseases, drug induced hypertension;
• Ongoing treatment with statins, fibrates, and/or cation exchange resins within 2 weeks;
• Pancreatic disease;
• History of gastrectomy, short bowel syndrome;
• Ongoing hormone replacement therapy;
• Diagnosed or suspected malignant tumor;
• Familial hypercholesterolemia;

Sponsors & Collaborators

• Jun Tao: lead
• Sun Yat-sen University: collaborator

Study Sites (13)

Fourth People's Hospital of Chongqing

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

NOT YET RECRUITING

People's Hospital of Zhongshan City

Zhongshan, Guangdong, 528403, China

RECRUITING

First Affiliated Hospital of Zhengzhou University

Zhengzhou, He'nan, 450052, China

RECRUITING

Yichang Central Hospital

Yichang, Hubei, 443003, China

RECRUITING

Taizhou Hospital of TCM

Taizhou, Jiangsu, 214504, China

RECRUITING

Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China

RECRUITING

Subei People's Hospital of Jiangsu province

Yangzhou, Jiangsu, 225001, China

NOT YET RECRUITING

Lanzhou University Second Hospital

Lanzhou, Qinghai, 730030, China

RECRUITING

Yantaishan Hospital, Yantai

Yantai, Shandong, 264001, China

NOT YET RECRUITING

Related Publications (10)

• Maki KC, Ridker PM, Brown WV, Grundy SM, Sattar N, The Diabetes Subpanel of the National Lipid Association Expert Panel. An assessment by the Statin Diabetes Safety Task Force: 2014 update. J Clin Lipidol. 2014 May-Jun;8(3 Suppl):S17-29. doi: 10.1016/j.jacl.2014.02.012.

  PMID: 24793439 BACKGROUND

• Yusuf S, Lonn E, Pais P, Bosch J, Lopez-Jaramillo P, Zhu J, Xavier D, Avezum A, Leiter LA, Piegas LS, Parkhomenko A, Keltai M, Keltai K, Sliwa K, Chazova I, Peters RJ, Held C, Yusoff K, Lewis BS, Jansky P, Khunti K, Toff WD, Reid CM, Varigos J, Accini JL, McKelvie R, Pogue J, Jung H, Liu L, Diaz R, Dans A, Dagenais G; HOPE-3 Investigators. Blood-Pressure and Cholesterol Lowering in Persons without Cardiovascular Disease. N Engl J Med. 2016 May 26;374(21):2032-43. doi: 10.1056/NEJMoa1600177. Epub 2016 Apr 2.

  PMID: 27039945 BACKGROUND

• Baudrand R, Pojoga LH, Vaidya A, Garza AE, Vohringer PA, Jeunemaitre X, Hopkins PN, Yao TM, Williams J, Adler GK, Williams GH. Statin Use and Adrenal Aldosterone Production in Hypertensive and Diabetic Subjects. Circulation. 2015 Nov 10;132(19):1825-33. doi: 10.1161/CIRCULATIONAHA.115.016759. Epub 2015 Oct 2.

  PMID: 26432671 BACKGROUND

• Warita S, Kawasaki M, Tanaka R, Ono K, Kojima T, Hirose T, Iwama M, Watanabe T, Nishigaki K, Takemura G, Noda T, Watanabe S, Minatoguchi S. Effects of pitavastatin on cardiac structure and function and on prevention of atrial fibrillation in elderly hypertensive patients: a prospective study of 2-years' follow-up. Circ J. 2012;76(12):2755-62. doi: 10.1253/circj.cj-12-0722. Epub 2012 Aug 8.

  PMID: 22878405 BACKGROUND

• Yoshika M, Komiyama Y, Masuda M, Yokoi T, Masaki H, Ohkura H, Takahashi H. Pitavastatin further decreases serum high-sensitive C-reactive protein levels in hypertensive patients with hypercholesterolemia treated with angiotensin II, type-1 receptor antagonists. Clin Exp Hypertens. 2010;32(6):341-6. doi: 10.3109/10641961003628460.

  PMID: 21028996 BACKGROUND

• Pearson TA, Mensah GA, Alexander RW, Anderson JL, Cannon RO 3rd, Criqui M, Fadl YY, Fortmann SP, Hong Y, Myers GL, Rifai N, Smith SC Jr, Taubert K, Tracy RP, Vinicor F; Centers for Disease Control and Prevention; American Heart Association. Markers of inflammation and cardiovascular disease: application to clinical and public health practice: A statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association. Circulation. 2003 Jan 28;107(3):499-511. doi: 10.1161/01.cir.0000052939.59093.45. No abstract available.

  PMID: 12551878 BACKGROUND

• Kushiro T, Mizuno K, Nakaya N, Ohashi Y, Tajima N, Teramoto T, Uchiyama S, Nakamura H; Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese Study Group. Pravastatin for cardiovascular event primary prevention in patients with mild-to-moderate hypertension in the Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA) Study. Hypertension. 2009 Feb;53(2):135-41. doi: 10.1161/HYPERTENSIONAHA.108.120584. Epub 2008 Dec 22.

  PMID: 19104004 BACKGROUND

• Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, MacFadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008 Nov 20;359(21):2195-207. doi: 10.1056/NEJMoa0807646. Epub 2008 Nov 9.

  PMID: 18997196 BACKGROUND

• Ridker PM, Macfadyen JG, Nordestgaard BG, Koenig W, Kastelein JJ, Genest J, Glynn RJ. Rosuvastatin for primary prevention among individuals with elevated high-sensitivity c-reactive protein and 5% to 10% and 10% to 20% 10-year risk. Implications of the Justification for Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial for "intermediate risk". Circ Cardiovasc Qual Outcomes. 2010 Sep;3(5):447-52. doi: 10.1161/CIRCOUTCOMES.110.938118. Epub 2010 Aug 24.

  PMID: 20736443 BACKGROUND

• Zhang J, Shao Y, Liu Y, Tao J. A Multi-Center, Open-Label, Two-Arm Parallel Group Non-inferiority Randomized Controlled Trial Evaluating the Effect of Pitavastatin, Compared to Atorvastatin, on Glucose Metabolism in Prediabetics with Hypertension and Dyslipidemia: Rationale and Design for the China Hemoglobin A1c Metabolism Protection Union Study (CAMPUS). Cardiovasc Drugs Ther. 2018 Dec;32(6):581-589. doi: 10.1007/s10557-018-6826-6.

  PMID: 30187345 DERIVED

MeSH Terms

Conditions

Prediabetic State; Hypertension; Dyslipidemias; Cardiovascular Diseases

Interventions

pitavastatin; Atorvastatin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Jun Tao, MD,PhD

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Jun Tao, MD,PhD

CONTACT

+8613922191609; taojungz123@163.com

Jianning Zhang

CONTACT

+8615521264372; ningjenny@yeah.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of the Department of Hypertension and Cardiovascular Disease, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 22, 2018
• Study Start: August 9, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2020
• Last Updated: June 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Study protocol will be published on scientific journal and is anticipated to be available online by the end of 2018. Statistical Analysis Plan will be finished before the trial ends. Clinical Study Report will be published in public no more than a year after the study completion.
• Access Criteria: All researchers will be available to get the individual participant data (IPD) as long as the information is published.

Locations

CN (13)