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Comparison of Low-Intensity Statin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus (PROVE-DM)

Primary Purpose

Pre Diabetes, ASCVD

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
high-intensity statin arm
low-intensity statin plus ezetimibe
Sponsored by
Seung-Whan Lee, M.D., Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men or women between the ages of 18 and 75 years who have prediabetes

    -Prediabetes consists of impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) or HbA1c

    1. IFG: fasting plasma glucose (FPG) 100 to 125 mg/dL
    2. IGT: 2 hours post-load glucose on the 75g OGTT (oral glucose tolerance test) 140 to 199 mg/dL
    3. HbA1c: 5.7 to 6.4%
  2. Patient requiring high-intensity statin due to high risk of a future cardiovascular event if at least one of the following criteria is present via patient history, physical examination, or medical records at the time of screening (Clinically documented ASCVD)

    • acute coronary syndrome (MI or unstable angina)
    • stable angina
    • coronary revascularization (PCI, CABG, and other arterial revascularization procedure)
    • stroke or TIA
    • peripheral arterial disease (<0.9 performed by a vascular lab or angiogram (including CTA) showing ≥ 50%) Unequivocally documented ASCVD on imaging

      • significant plaque on coronary angiography on CT (mild, moderate, severe coronary artery disease)
      • significant plaque on carotid ultrasound (mild, moderate, severe carotid disease)
  3. Patients who were not given statins (statin naive) or who were taking statins below the moderate -intensity.
  4. Patient must have been on a stable diet prior to randomization and willing to follow the NCEP (national Cholesterol Education Program) TLC (therapeutic lifestyle changes) diet, or equivalent diet, throughout the study.
  5. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

  1. Patient's pregnant or breast-feeding or child-bearing potential.
  2. The one who used to take high intensity statins. (40mg or more of atorvastatin, 20mg or more of rosuvastatin)
  3. Concomitant administration of potent inhibitors of CYP3A4 (itraconazole, ketoconazole, protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone) or CYP2C9 (relative contraindication not dependent on CYP450 statins).
  4. Chronic kidney disease (eGFR<30 ml/min/1.73m2) or dialysis-dependent renal failure
  5. Uncontrolled hypothyroidism.
  6. Personal or family history of hereditary muscular disorders.
  7. History of muscular toxicity with a statin
  8. Alcoholism.
  9. Hypersensitivity to any of statin and ezetimibe.
  10. Hemodynamic unstable conditions at the time of inclusion: cardiogenic shock at the time of randomization, refractory ventricular arrhythmias, or congestive heart failure (New York Heart Association class IV).
  11. Any history of hemorrhagic stroke or intracranial hemorrhage within the past 6 months
  12. Any surgery requiring discontinuation of statin and/or ezetimibe is planned within 6 months after randomization
  13. A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
  14. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
  15. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
  16. Life expectancy < 1 years for any non-cardiac or cardiac causes
  17. Unwillingness or inability to comply with the procedures described in this protocol.
  18. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  19. People who have previously been diagnosed with diabetes and are taking lifestyle modification and oral hypoglycemic agent (OHA) or insulin

Sites / Locations

  • Bycheon Sejong Hospital
  • Gyeongsang National University Changwon Hospital
  • Chungbuk National University Hospital
  • Gangwon National University Hospital
  • Daegu Catholic University Medical Center
  • Keimyung University Dongsan Medical Center
  • Chungnam National University Sejong Hospital
  • Gangneung Asan Hospital
  • Gachon University Gil Medical Center
  • Jeju National University Hospital
  • Gyeongsang National University Hospital
  • Dong-A Medical Center
  • Inje University Busan Paik Hospital
  • Kosin University Gospel Hospital
  • Pusan National University Yangsan Hospital
  • Asan Medical CenterRecruiting
  • Hallym University Medical Center-Kangdong
  • Korea University Anam Hospital
  • The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
  • The Catholic University of Korea, St. Vincent's Hospital
  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

high-intensity statin arm

low-intensity statin plus ezetimibe arm

Arm Description

(high-intensity statin arm): rosuvastatin 20 mg PO qd, once daily

(low-intensity statin plus ezetimibe arm ): rosuvastatin 5mg /ezetimibe 10mg PO qd), once daily

Outcomes

Primary Outcome Measures

Number of Participants with New-onset-DM
New onset DM was defined on the the basis of the American Diabetes association guideline if two abnormal test results of following criteria are existed from the same sample or in two separate test samples. fasting plasma glucose (FPG) ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 hours OR 2 hour plasma glucose during a 75 g oral glucose tolerance test (OGTT) ≥200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water OR HbA1C ≥6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP (National Glycohemoglobin Standardization Program) certified and standardized to the DCCT (Diabetes Control and Complication Trial) assay.
Number of Participants with death
Major adverse cardiac events are defined as all-cause death

Secondary Outcome Measures

Composite cardiovascular safety
death from cardiovascular cause, non fatal myocardial infarction of nom fatal stroke
Any arterial revascularization
Any arterial revascularization (carotid, coronary aorta or peripheral artery) Any arterial revascularization (carotid, coronary aorta or peripheral artery)
Any potential side effect
Any potential side effect
Each component of the diabetes-mellitus diagnosis criteria
Each component of the diabetes-mellitus diagnosis criteria
All cause mortality
All cause mortality

Full Information

First Posted
October 11, 2022
Last Updated
June 8, 2023
Sponsor
Seung-Whan Lee, M.D., Ph.D.
Collaborators
Yuhan Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05579626
Brief Title
Comparison of Low-Intensity Statin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus (PROVE-DM)
Official Title
Comparison of Low-Intensity Statin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus in Prediabetic Patients With Atherosclerotic Cardiovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
December 30, 2027 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Whan Lee, M.D., Ph.D.
Collaborators
Yuhan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is to evaluating the impact of low-intensity statin plus ezetimibe versus high-intensity statin therapy on risk of new-onset diabetes mellitus in patients with atherosclerotic cardiovascular disease who have prediabetes.
Detailed Description
The PROVE-DM trial is a multi-center, open-labeled, randomized controlled trial comparing two different lipid lowering strategies in patients with prediabetes and established atherosclerosis. Patients with prediabetes and documented atherosclerosis, either clinical or unequivocal on imaging are eligible for enrollment. The detailed information for inclusion and exclusion criteria is described below in the session 4. Patients meeting inclusion criteria without any exclusion criteria are assessed to be able to tolerate high-intensity statin therapy while achieving the target LDL level (LDL cholesterol < 70 mg/dL for established atherosclerotic cardiovascular disease or LDL cholesterol < 100 mg/dL for mild to moderate coronary artery disease) through a run-in period of 2 to 6 months. (Run in period was set as a screening process to reduce drop-out cases that cannot withstand high-intensity statins or cannot accomplished target LDL levels) Eligible patients will be randomized to high-intensity statin (rosuvastatin 20 mg qd) or low-intensity statin plus ezetimibe (rosuvastatin 5/10mg/ ezetimibe 10 mg qd). Patients will be followed-up clinically at 6, 12 months and then annually up to 3 years after randomization. Follow-up measurement of DM diagnostic criteria (fasting plasma glucose, plasma Hb A1c, oral glucose tolerance test) and lipid profile is intended to 1) provide evidence of new onset DM, 2) evaluate effectiveness of lowering LDL cholesterol. To ensure the accurate assessment of the clinical outcomes, cardiovascular safety end point (death from cardiovascular causes, non-fatal myocardial infarction, or non-fatal stroke), any arterial revascularization, any potential side effects of statin and all-cause mortality were also investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes, ASCVD

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high-intensity statin arm
Arm Type
Active Comparator
Arm Description
(high-intensity statin arm): rosuvastatin 20 mg PO qd, once daily
Arm Title
low-intensity statin plus ezetimibe arm
Arm Type
Active Comparator
Arm Description
(low-intensity statin plus ezetimibe arm ): rosuvastatin 5mg /ezetimibe 10mg PO qd), once daily
Intervention Type
Drug
Intervention Name(s)
high-intensity statin arm
Intervention Description
•high-intensity statin strategy (standard arm): rosuvastatin 20 mg PO qd, once daily
Intervention Type
Drug
Intervention Name(s)
low-intensity statin plus ezetimibe
Intervention Description
•low-intensity statin plus ezetimibe strategy (experimental arm): rosuvastatin 5mg /ezetimibe 10mg PO qd), once daily
Primary Outcome Measure Information:
Title
Number of Participants with New-onset-DM
Description
New onset DM was defined on the the basis of the American Diabetes association guideline if two abnormal test results of following criteria are existed from the same sample or in two separate test samples. fasting plasma glucose (FPG) ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 hours OR 2 hour plasma glucose during a 75 g oral glucose tolerance test (OGTT) ≥200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water OR HbA1C ≥6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP (National Glycohemoglobin Standardization Program) certified and standardized to the DCCT (Diabetes Control and Complication Trial) assay.
Time Frame
36months after randomization
Title
Number of Participants with death
Description
Major adverse cardiac events are defined as all-cause death
Time Frame
36months after randomization
Secondary Outcome Measure Information:
Title
Composite cardiovascular safety
Description
death from cardiovascular cause, non fatal myocardial infarction of nom fatal stroke
Time Frame
36months after randomization
Title
Any arterial revascularization
Description
Any arterial revascularization (carotid, coronary aorta or peripheral artery) Any arterial revascularization (carotid, coronary aorta or peripheral artery)
Time Frame
36months after randomization
Title
Any potential side effect
Description
Any potential side effect
Time Frame
36months after randomization
Title
Each component of the diabetes-mellitus diagnosis criteria
Description
Each component of the diabetes-mellitus diagnosis criteria
Time Frame
36months after randomization
Title
All cause mortality
Description
All cause mortality
Time Frame
36months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women between the ages of 18 and 75 years who have prediabetes -Prediabetes consists of impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) or HbA1c IFG: fasting plasma glucose (FPG) 100 to 125 mg/dL IGT: 2 hours post-load glucose on the 75g OGTT (oral glucose tolerance test) 140 to 199 mg/dL HbA1c: 5.7 to 6.4% Patient requiring high-intensity statin due to high risk of a future cardiovascular event if at least one of the following criteria is present via patient history, physical examination, or medical records at the time of screening (Clinically documented ASCVD) acute coronary syndrome (MI or unstable angina) stable angina coronary revascularization (PCI, CABG, and other arterial revascularization procedure) stroke or TIA peripheral arterial disease (<0.9 performed by a vascular lab or angiogram (including CTA) showing ≥ 50%) Unequivocally documented ASCVD on imaging significant plaque on coronary angiography on CT (mild, moderate, severe coronary artery disease) significant plaque on carotid ultrasound (mild, moderate, severe carotid disease) Patients who have never taken a statin or who do not have problems adhering to statin therapy Patient must have been on a stable diet prior to randomization and willing to follow the NCEP (national Cholesterol Education Program) TLC (therapeutic lifestyle changes) diet, or equivalent diet, throughout the study. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site. Exclusion Criteria: Patient's pregnant or breast-feeding or child-bearing potential. Concomitant administration of potent inhibitors of CYP3A4 (itraconazole, ketoconazole, protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone) or CYP2C9 (relative contraindication not dependent on CYP450 statins). Chronic kidney disease (eGFR<30 ml/min/1.73m2) or dialysis-dependent renal failure Uncontrolled hypothyroidism. Personal or family history of hereditary muscular disorders. History of muscular toxicity with a statin Alcoholism. Hypersensitivity to any of statin and ezetimibe. Hemodynamic unstable conditions at the time of inclusion: cardiogenic shock at the time of randomization, refractory ventricular arrhythmias, or congestive heart failure (New York Heart Association class IV). Any history of hemorrhagic stroke or intracranial hemorrhage within the past 6 months Any surgery requiring discontinuation of statin and/or ezetimibe is planned within 6 months after randomization A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal). Life expectancy < 1 years for any non-cardiac or cardiac causes Unwillingness or inability to comply with the procedures described in this protocol. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. People who have previously been diagnosed with diabetes and are taking lifestyle modification and oral hypoglycemic agent (OHA) or insulin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Su-Bin Shin, RN
Phone
8272577718
Email
tls7718@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Seung-Whan Lee, MD
Phone
82230103170
Email
seungwlee@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Whan Lee, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bycheon Sejong Hospital
City
Bucheon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ha-Wook Park, MD
Email
drpark.korea@gmail.com
First Name & Middle Initial & Last Name & Degree
Ha-Wook Park, MD
Facility Name
Gyeongsang National University Changwon Hospital
City
Changwon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Seok Bae, MD
Email
baefach@naver.com
First Name & Middle Initial & Last Name & Degree
Jae Seok Bae, MD
Facility Name
Chungbuk National University Hospital
City
Cheonju
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Min Kim, MD
Email
sangmin3410@gmail.com
First Name & Middle Initial & Last Name & Degree
Sang Min Kim, MD
Facility Name
Gangwon National University Hospital
City
Chuncheon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bong-Ki Lee, MD
Email
mdbklee@kangwon.ac.kr
First Name & Middle Initial & Last Name & Degree
Bong-Ki Lee, MD
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-bae Lee, MD
Email
jblee@cu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jin-bae Lee, MD
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyuck-Jun Yoon, MD
Email
hippsons@dsmc.or.kr
First Name & Middle Initial & Last Name & Degree
Hyuck-Jun Yoon, MD
Facility Name
Chungnam National University Sejong Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Hwan Lee, MD
Email
myheart@cnuh.co.kr
First Name & Middle Initial & Last Name & Degree
Jae-Hwan Lee, MD
Facility Name
Gangneung Asan Hospital
City
Gangneung
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han-Bit Park, MD
Email
phb8012@gmail.com
First Name & Middle Initial & Last Name & Degree
Han-Bit Park, MD
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyoung-Hun Lee, MD
Email
vancolee@gmail.com
First Name & Middle Initial & Last Name & Degree
Kyoung-Hun Lee, MD
Facility Name
Jeju National University Hospital
City
Jeju
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Geun Lee, MD
Email
tedljg@naver.com
First Name & Middle Initial & Last Name & Degree
Jae-Geun Lee, MD
Facility Name
Gyeongsang National University Hospital
City
Jinju
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Sin Koh, MD
Email
kjs0175@gmail.com
First Name & Middle Initial & Last Name & Degree
Jin-Sin Koh, MD
Facility Name
Dong-A Medical Center
City
Pusan
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong-Rak Cho, MD
Email
nephrone@hanmail.net
First Name & Middle Initial & Last Name & Degree
Yong-Rak Cho, MD
Facility Name
Inje University Busan Paik Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Hyun Yang, MD
Email
yangthmd@naver.com
First Name & Middle Initial & Last Name & Degree
Tae Hyun Yang, MD
Facility Name
Kosin University Gospel Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Ho Heo, MD
Email
duggymdc@gmail.com
First Name & Middle Initial & Last Name & Degree
Jung Ho Heo, MD
Facility Name
Pusan National University Yangsan Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kook Jin Chun, MD
Email
ptca82@gmail.com
First Name & Middle Initial & Last Name & Degree
Kook Jin Chun, MD
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-Whan Lee, MD
Email
seungwlee@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Tae Oh Kim, MD
Email
allldie_7@naver.com
First Name & Middle Initial & Last Name & Degree
Seung-Whan Lee, MD
First Name & Middle Initial & Last Name & Degree
Cheol whan Lee, MD
First Name & Middle Initial & Last Name & Degree
Tae Oh Kim, MD
Facility Name
Hallym University Medical Center-Kangdong
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Eun Kim, MD
Email
drhyangii@gmail.com
First Name & Middle Initial & Last Name & Degree
Sung-Eun Sung-Eun, MD
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soon Jun Hong, MD
Email
psyche94@hanmail.net
First Name & Middle Initial & Last Name & Degree
Soon Jun Hong, MD
Facility Name
The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeon-Jik Choi, MD
Email
lozenge@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Yeon-Jik Choi, MD
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong-Ho Heo, MD
Email
hhhsungho@naver.com
First Name & Middle Initial & Last Name & Degree
Seong-Ho Heo, MD
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gyung-Min Park, MD
Email
min8684@hanmail.net
First Name & Middle Initial & Last Name & Degree
Gyung-Min Park, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Low-Intensity Statin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus (PROVE-DM)

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