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Effect of Atorvastatin on Carotid Intima Media Thickness

Primary Purpose

Essential Hypertension, Hypercholesterolemia

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Perindopril/Amlodipine and Perindopril/Amlodipine/Atorvastatin treatment
Sponsored by
Yerevan State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring arterial hypertension, statin, carotid artery intima-media thickness

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Perindopril/Amlodipine arm

    Perindopril/Amlodipine/Atorvastatin arm

    Arm Description

    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 . We will study the effects of 6-month treatment with perindopril +amlodipin+atorvastatin combination on plasma concentrations of total cholesterol and LDL cholesterol.

    Outcomes

    Primary Outcome Measures

    The change in mean IMT of the CCA from baseline to 6 months in two groups and antihypertensive treatment efficacy in both groups .
    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.

    Secondary Outcome Measures

    Assessment of level of total and LDL cholesterol concentrations in blood plasma after 6 months of treatment in both groups.
    Assessment of level of total and LDL cholesterol concentrations in blood plasma after 6 months of treatment in both groups and correlation between carotid IMT and values of total cholesterol and LDL levels in blood plasma.

    Full Information

    First Posted
    February 24, 2020
    Last Updated
    March 10, 2020
    Sponsor
    Yerevan State Medical University
    Collaborators
    Servier
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04306627
    Brief Title
    Effect of Atorvastatin on Carotid Intima Media Thickness
    Official Title
    Evaluation of Carotid Intima Media Thickness by Treatment of Vascular and Metabolic Factors With Combined Antihypertensive and Hypolipidemic Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 15, 2020 (Anticipated)
    Primary Completion Date
    October 16, 2020 (Anticipated)
    Study Completion Date
    February 28, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yerevan State Medical University
    Collaborators
    Servier

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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 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 .
    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 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 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 > 2,5mm/L (without concomitant hypolipidemic drugs) 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. Adverse events (AE) Based on the intention-to-treat the patient population, safety will be checked by recording adverse effects throughout the study: severe AEs regardless as to whether or not there is causal relationship between the AEs and the study; and relevant AEs such as myalgia, cough , palpitations, peripheric edemas, diziness symptoms. When the investigators confirm these AEs, the grade of severity, procedures, outcomes, and relationship to the study drug will be assessed and recorded. Serious adverse event (SAE) A serious adverse event is an AE occurring during any study phase and at any dose of the investigational product that fulfills one or more of the following criteria: results in death, is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above. The Investigator must inform the Sponsor of any SAE that occurs in the course of the study within 48 hours of when he or she becomes aware of it. Carotid Ultrasound An ultrasound linear probe with 5-10 MHz linear transducer will be used for measuring the carotid artery intima media thickness ( IMT ). The carotid artery will be scanned by 3 trained in vascular ultrasound and echocardiography physicians. All study subjects will be examined in the supine position with the head tilted backward. Measurements of the left and right IMT of the posterior wall of the common carotid, 1 cm distal to the bulb bifurcation, by ultrasound 2D exam will be performed Blood pressure (BP) will be measured at the University Cardiology Clinic by a trained nurse or physician using a calibrated and validated digital sphygmomanometer. BP measurements will be taken with the patient in a seated position with the arm supported at heart level, after a 5 min rest and after abstaining from food, beverages containing caffeine, and smoking for at least 2 h prior to BP measurement. BP will be recorded as three serial measurements at intervals of 30 sec on both arms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Essential Hypertension, Hypercholesterolemia
    Keywords
    arterial hypertension, statin, carotid artery intima-media thickness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Endpoints of study The primary endpoints in the study is the change in mean IMT of the CCA from baseline to 6 months in two groups and antihypertensive treatment efficacy in both groups . The secondary endpoints are assessment of level of total and LDL cholesterol concentrations in blood plasma after 6 months of treatment in both groups and correlation between carotid IMT and values of total cholesterol and LDL levels in blood plasma.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Perindopril/Amlodipine arm
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Perindopril/Amlodipine/Atorvastatin arm
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Perindopril/Amlodipine and Perindopril/Amlodipine/Atorvastatin treatment
    Intervention Description
    comparative antihypertensive antilipidemic treatment assessment on carotid intima media thickness in both study groups
    Primary Outcome Measure Information:
    Title
    The change in mean IMT of the CCA from baseline to 6 months in two groups and antihypertensive treatment efficacy in both groups .
    Description
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Assessment of level of total and LDL cholesterol concentrations in blood plasma after 6 months of treatment in both groups.
    Description
    Assessment of level of total and LDL cholesterol concentrations in blood plasma after 6 months of treatment in both groups and correlation between carotid IMT and values of total cholesterol and LDL levels in blood plasma.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hamayak S Sisakian, MD
    Phone
    +37410582023
    Email
    hamayak.sisakian@doctor.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hamayak Sisakian, MD
    Organizational Affiliation
    Yerevan State Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Atorvastatin on Carotid Intima Media Thickness

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