HypertensionPhase 4EPOCHNCT02144922
Effect of Pitavastatin on Coronary Flow Reserve in Hypertensive Patients
A Phase 4 study testing Pitavastatin in people with Hypertension and Cardiovascular Risk, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Hypertension, Cardiovascular Risk
- What is being tested?
- Pitavastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Oct 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pitavastatin on Coronary Flow Reserve in Hypertensive Patients With Cardiovascular Risk
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.
Read the 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.
- Conditions
- Hypertension, Cardiovascular Risk
- Being tested
- Pitavastatin, Control
- Keywords
- Hypertension, Statin
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
Also called Livalo
statin
ControlOther
Life style modification alone
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Patients continue taking their antihypertensive medication alone. Receives: 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. Receives: Drug: Pitavastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Difference in mean CFR value
DIfference in CFR value at 12 month follow-up between pitavastatin and placebo arm
Measured: 12 months
Secondary outcomes (3)
change of CRP
Change of CRP from baseline to 1 year follow-up.
Measured: 12 months
Change of LDL-cholesterol
Change of LDL-cholesterol from baseline to 1 year follow-up.
Measured: 12 months
Change of averaged peak diastolic velocity
Change of averaged peak diastolic velocity from baseline to study end.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- JW Pharmaceutical
- Responsible party
- Principal investigator, Duk-Hyun Kang, Asan Medical Center
- Investigators
- Duk-Hyun Kang, M.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144922
- Sponsor's protocol ID
- 2013-1091
- Acronym
- EPOCH
- Status last verified
- Oct 2016
- First submitted
- 20 May 2014
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pitavastatin on Coronary Flow Reserve in Hypertensive Patients With Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT02144922
- Acronym / sponsor ID
- EPOCH / 2013-1091
- Conditions
- Hypertension, Cardiovascular Risk
- Keywords
- Hypertension, Statin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- JW Pharmaceutical
- Study start
- May 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlPatients continue taking their antihypertensive medication alone. |
| Pitavastatin | Active comparator | Drug: PitavastatinPitavastatin 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. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PitavastatinAlso: Livalostatin | Drug | Pitavastatin |
| ControlLife style modification alone | Other | Control |
Primary outcome
change in the CFR value
Time frame: 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.
Difference in mean CFR value
Time frame: 12 months
DIfference in CFR value at 12 month follow-up between pitavastatin and placebo arm
3 secondary outcomes
change of CRP
Time frame: 12 months
Change of LDL-cholesterol
Time frame: 12 months
Change of averaged peak diastolic velocity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duk-Hyun Kang, M.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pitavastatin in people with Hypertension and Cardiovascular Risk, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the CFR value (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.