Effect of Atorvastatin on Carotid Intima Media Thickness

• Status: Not yet recruiting
• Trial end date: 2021-02-28
• Target enrollment: 0
• Participant gender: All

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 atherosclerosis progression. The fixed association of atorvastatin, perindopril and amlodipine under the name of Lipertance is the first fixed combination of these three groups to control the risk factors that are hypertension and dyslipidemia which can be used both in primary and secondary cardiovascular prevention .

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yerevan State Medical University
• Collaborator: Servier
• Treatments: Amlodipine; Amlodipine, atorvastatin drug combination; Atorvastatin; Perindopril

Criteria

Inclusion Criteria:

• • 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 Criteria:

• 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