Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Yuhan Corporation
Age
19–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Written informed consent
2. Aged 19 to 75 years
3. 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
4. Those who are taking antihypertensive drugs, or SBP \> 140mmHg or DBP \> 90mmHg on the left side
5. 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 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%
You may not be if
1. Those who are treated with secondary hypertension or malignant hypertension
2. Uncontrollable diabetes with HbA1c ≥ 10%
3. Total cholesterol ≥ 300mg/dL
4. Fasting LDL-C ≤ 70 mg/dL
5. Fasting triglyceride ≥ 500 mg/dL
6. History of muscular disease or rhabdomyolysis due to use of statin
7. Hypersensitive to statin or ARBs
8. 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
9. Those who are participating in clinical trials of other investigational products
10. 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
11. Other than the above who is deemed to be ineligible to participate in the trial by investigator
Clareo Health | High-Dose Statin Combined With Telmisartan vs Amlodipine on Glucose Metabolism in ASCVD Patients With IFG and Hypertension
