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EPOCH: Effect of Pitavastatin on Coronary Flow Reserve in Hypertensive Patients

Sponsor
Asan Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02144922
Collaborator
JW Pharmaceutical (Industry)
85
Enrollment
1
Location
2
Arms
29
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Although statins reduce cardiac events in hypertensive patients with cardiovascular risk factors, the effect of statins on coronary flow reserve (CFR) has not been examined in such patients. The investigators hypothesize that pitavastatin added to standard antihypertensive therapy will be superior to placebo in improving CFR in hypertensive patients with cardiovascular risk, and try to examine this hypothesis in a double-blind, randomized comparison study using Doppler echocardiography.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Statin treatment improves coronary flow reserve (CFR) and decreases cardiac morbidity and mortality in patients with coronary artery disease (CAD) and hypercholesterolemia. Endothelial dysfunction and impairment in coronary microcirculation is also observed in hypertensive patients with cardiovascular risk factors. However, the measurement of CFR has rarely been performed in hypertensive patients without CAD, because CFR could be invasively measured using a Doppler guide wire in a cardiac catheterization laboratory. Recent advances in echocardiographic imaging techniques have made it possible to measure coronary flow velocity and CFR, which highly correlates with the CFR measured by invasive means.

Lipid lowering with a statin provided beneficial effects in patients with average levels of serum total cholesterol in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA) study conducted in hypertensive patients at cardiovascular risk. Improvements in endothelial dysfunction and CFR may be related to the beneficial effects of statins in hypertensive patients without hypercholesterolemia, but the effect of statins on CFR has not been examined in such patients. Accordingly, the investigators try to examine the hypothesis that pitavastatin added to standard antihypertensive therapy in hypertensive patients with cardiovascular risk will be superior to placebo in improving CFR in a double-blind, randomized comparison study using Doppler echocardiography.

Study Design

Study Type:
Interventional
Actual Enrollment :
85 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Pitavastatin on Coronary Flow Reserve in Hypertensive Patients With Cardiovascular Risk
Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control

Patients continue taking their antihypertensive medication alone.

Other: Control
Life style modification alone
Active Comparator: Pitavastatin

Pitavastatin 4 mg is given to study patients after a baseline assessment and continued for 1 year without further dose titration. Patients continue taking their antihypertensive medication during the entire follow-up period.

Drug: Pitavastatin
statin
Other Names:
  • Livalo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change in the CFR value [12 months]

      Change of coronary flow velocity reserve from baseline to 1 year follow-up. For each patient, the averaged value of coronary flow velocity reserve will be obtained at baseline and 1 year follow-up.

    2. Difference in mean CFR value [12 months]

      DIfference in CFR value at 12 month follow-up between pitavastatin and placebo arm

    Secondary Outcome Measures

    1. change of CRP [12 months]

      Change of CRP from baseline to 1 year follow-up.

    2. Change of LDL-cholesterol [12 months]

      Change of LDL-cholesterol from baseline to 1 year follow-up.

    3. Change of averaged peak diastolic velocity [12 months]

      Change of averaged peak diastolic velocity from baseline to study end.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Controlled Hypertension: treated SBP<140 mmHg and DBP<90 mmHg

    • LDL cholesterol ≥ 130mg/dL

    • Patients with statin-naive state, defined as receiving no statin therapy for more than 6 months during the previous 12 months.

    • Any 1 of these cardiovascular risk factors required: smoking, age over 55 (men) or 65 (women), history of cerebrovascular event, family history of early CHD before age 55, HDL cholesterol < 40 mg/dL

    Exclusion Criteria:

    • A previous history of intolerance or hypersensitivity to statins

    • Uncontrolled hypertension; SBP≥140 mmHg or DBP≥90 mmHg

    • Previous MI or currently treated angina pectoris

    • Stroke, TIA < 3 months

    • Secondary hypertension

    • Fasting serum triglyceride > 500 mg/dL

    • Clinical congestive heart failure

    • Uncontrolled arrhythmia

    • Left ventricular hypertrophy: LV mass index >134g/m2 (male) or >110g/m2 (female)

    • Concomitant clinically important hematological, gastrointestinal, hepatic, renal or other disease

    • Pregnant or lactating women and those of child-bearing potential

    • Diabetes

    • Peripheral vascular disease

    • Unwillingness or inability to comply with the procedures described in this protocol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of 138-736

    Sponsors and Collaborators

    • Asan Medical Center
    • JW Pharmaceutical

    Investigators

    • Principal Investigator: Duk-Hyun Kang, M.D., Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duk-Hyun Kang, Professor, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT02144922
    Other Study ID Numbers:
    • 2013-1091
    First Posted:
    May 22, 2014
    Last Update Posted:
    Oct 14, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Duk-Hyun Kang, Professor, Asan Medical Center
    Hypertension
    Statin
    Additional relevant MeSH terms:
    Hypertension
    Pitavastatin

    Study Results

    No Results Posted as of Oct 14, 2016