NCT02144922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started May 2014

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

2.4 years

First QC Date

May 20, 2014

Last Update Submit

October 13, 2016

Conditions

HypertensionCardiovascular Risk

Keywords

HypertensionStatin

Outcome Measures

Primary Outcomes (2)

  • change in the CFR value

    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.

    12 months

  • Difference in mean CFR value

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

    12 months

Secondary Outcomes (3)

  • change of CRP

    12 months

  • Change of LDL-cholesterol

    12 months

  • Change of averaged peak diastolic velocity

    12 months

Study Arms (2)

Control

PLACEBO COMPARATOR

Patients continue taking their antihypertensive medication alone.

Other: Control

Pitavastatin

ACTIVE COMPARATOR

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

Interventions

PitavastatinDRUG

statin

Also known as: Livalo
Pitavastatin
ControlOTHER

Life style modification alone

Control

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

pitavastatin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Duk-Hyun Kang, M.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 22, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 14, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)