Evaluation of Carotid Intima Media Thickness by Treatment of Vascular and Metabolic Factors With Combined Antihypertensive and Hypolipidemic Therapy
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 主要终点
- The change in mean IMT of the CCA from baseline to 6 months in two groups and antihypertensive treatment efficacy in both groups .
研究概览
简要总结
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 .
详细描述
Eligible participants with appropriately signed informed consent will be randomized to either the perindopril+amlodipin or perindopril+amlodipin+atorvastatin combinations.
Patients will be preliminary screened before 7-10 days for clinical and laboratory examination to meet eligibility criteria for inclusion in study.
Perindopril+amlodipine combination doses will be up titrated over two weeks in case of need to control adequate arterial blood pressure < 140/90. The 4 doses combinations and their adjustments will be made by investigating physician according to guideline based treatment of arterial hypertension and dyslipidemia.
Subjects should not previously be on statin therapy and subjects who needs to be will start atorvastatin in combination treatment pill . The investigators will study the effects of 6-month treatment with perindopril +amlodipin+atorvastatin combination on plasma concentrations of total cholesterol and LDL cholesterol. Liver enzyme markers will be assessed in patients on additional statin treatment on day 90 for safety assessment. All participants will be followed-up for 6 months.
Inclusion criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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.
排除标准
- •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
研究组 & 干预措施
Perindopril/Amlodipine arm
Patients will be preliminary screened before 7-10 days for clinical and laboratory examination to meet eligibility criteria for inclusion in study.
Perindopril+amlodipine combination doses will be up titrated over two weeks in case of need to control adequate arterial blood pressure < 140/90. The 4 doses combinations and their adjustments will be made by investigating physician according to guideline based treatment of arterial hypertension and dyslipidemia.
干预措施: Perindopril/Amlodipine and Perindopril/Amlodipine/Atorvastatin treatment (Drug)
Perindopril/Amlodipine/Atorvastatin arm
Subjects should not previously be on statin therapy and subjects who needs to be will start atorvastatin in combination treatment pill . We will study the effects of 6-month treatment with perindopril +amlodipin+atorvastatin combination on plasma concentrations of total cholesterol and LDL cholesterol.
干预措施: Perindopril/Amlodipine and Perindopril/Amlodipine/Atorvastatin treatment (Drug)
结局指标
主要结局
The change in mean IMT of the CCA from baseline to 6 months in two groups and antihypertensive treatment efficacy in both groups .
时间窗: 6 months
The fixed association of atorvastatin, perindopril and amlodipine is the first fixed combination of these three groups to control the risk factors that are hypertension and dyslipidemia. Additive effects of combined antihypertensive medications and statin in a single pill combination may better reduce progression of vascular remodeling and inhibit atherosclerosis progression.
次要结局
- Assessment of level of total and LDL cholesterol concentrations in blood plasma after 6 months of treatment in both groups.(6 months)