Status:
UNKNOWN
Effect of Atorvastatin on Carotid Intima Media Thickness
Lead Sponsor:
Yerevan State Medical University
Collaborating Sponsors:
Servier
Conditions:
Essential Hypertension
Hypercholesterolemia
Eligibility:
All Genders
45-85 years
Phase:
PHASE4
Brief Summary
The investigators hypothesize that additive effects of combined antihypertensive medications and statin in a single pill combination may better reduce progression of vascular remodeling and inhibit at...
Detailed Description
Eligible participants with appropriately signed informed consent will be randomized to either the perindopril+amlodipin or perindopril+amlodipin+atorvastatin combinations. Patients will be preliminar...
Eligibility Criteria
Inclusion
- • Patients aged between 45 and 85 years
- blood pressure ≥ 140/90 mmHg with one antihypertensive drug or 150/100 mHg for untreated patients
- plasma LDL-cholesterol concentrations \> 4.1 mmol/L without hypolipidemic drugs within the last 6 months
- at least one additional cardiovascular risk factor apart of arterial hypertension
- minimal thickness of intima media complex at least 0,8 mm.
Exclusion
- premenopausal females with potential for pregnancy
- angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker therapy in the previous 3 months,
- initiation or change in dose of statin therapy within previous 3 months
- anticipated change in lipid lowering therapy
- acute coronary or cerebrovascular event within 2 months
- glomerular filtration rate \< 30 ml/min
- previous history of side effects to RAAS inhibitors and Ca channel blocking agents
- inability to give informed consent
- inability to undergo carotid ultrasound examination
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04306627
Start Date
April 15 2020
End Date
February 28 2021
Last Update
March 13 2020
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