Status:
COMPLETED
High-Dose Statin Combined With Telmisartan vs Amlodipine on Glucose Metabolism in ASCVD Patients With IFG and Hypertension
Lead Sponsor:
Yuhan Corporation
Conditions:
ASCVD
Impaired Fasting Glucose
Eligibility:
All Genders
19-75 years
Phase:
PHASE4
Brief Summary
This study will evaluate the effect of high-dose rosuvastatin combined with telmisartan or amlodipine on glucose metabolism in ASCVD patients with impaired fasting glucose and hypertension.
Eligibility Criteria
Inclusion
- Written informed consent
- Aged 19 to 75 years
- Patients with ASCVD requiring high-intensity statin therapy (in accordance with the clinical ASCVD diagnostic criteria in the 2013 ACC/AHA Guideline)
- \- Coronary artery disease
- acute coronary syndrome
- history of myocardial infarction (MI)
- stable or unstable angina
- history of coronary revascularization
- stroke or transient ischemic attack (TIA)
- peripheral arterial disease, history of peripheral arterial revascularization
- Those who are taking antihypertensive drugs, or SBP \> 140mmHg or DBP \> 90mmHg on the left side
- High-risk group (except for gestational diabetes) who has not been diagnosed with diabetes before, and who falls under one of the following criteria:
- impaired fasting glucose (IFG): 100-125 mg/dL (5.6-6.9 mmol/L)
- impaired glucose tolerance (IGT): plasma blood glucose 140-199mg/dL (7.8 to 11.0 mmol/L) 2 hours after oral administration of glucose 75g
- HbA1c: 5.7-6.4%
Exclusion
- Those who are treated with secondary hypertension or malignant hypertension
- Uncontrollable diabetes with HbA1c ≥ 10%
- Total cholesterol ≥ 300mg/dL
- Fasting LDL-C ≤ 70 mg/dL
- Fasting triglyceride ≥ 500 mg/dL
- History of muscular disease or rhabdomyolysis due to use of statin
- Hypersensitive to statin or ARBs
- Contraindications stated in the SPC of telmisartan or rosuvastatin including the following:
- severe renal disease (CrCL \< 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) \< 30mL/min/1.73m2)
- ALT, AST \> 3x ULN or history of active liver disease
- CPK \> 3x ULN
- hyperkalemia with serum K \> 5.5 mEq/l
- Those who are participating in clinical trials of other investigational products
- Those who cannot discontinue all other treatment for hypertension or hyperlipidemia than the investigational products, and concomitant medications and supplements that can affect the therapeutic effect of hypertension and hyperlipidemia during the trial period
- Other than the above who is deemed to be ineligible to participate in the trial by investigator
Key Trial Info
Start Date :
April 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03474562
Start Date
April 3 2018
End Date
June 7 2019
Last Update
June 2 2021
Active Locations (4)
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1
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
2
Dankook University Hospital
Cheonan, South Korea
3
Gangnam Severance Hospital
Seoul, South Korea
4
Severance Hospital
Seoul, South Korea