Coronary Artery DiseasePhase 4PREVUSNCT01230216
Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
A Phase 4 study of Coronary Artery Disease and Hypertension, run by Takeshi Morimoto at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary artery disease. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Coronary Artery Disease, Hypertension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2010to Apr 2015
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary artery diseases which require coronary angiography or percutaneous coronary intervention
- primary hypertension (systolic blood pressure 140-180mmHg within one month)
Who cannot join
- severe hypertension
- secondary hypertension
- treated with more than three antihypertensive drugs
- left main trunk trunk coronary artery disease
- moderate heart failure
- severe valvular disease
- liver dysfunction renal dysfunction (Cr>=2.0mg/dl) Pregnant or nursing women severe arrhythmia
Trial locations and contacts
1 site in 1 country.
Japan1 site
Division of Cardiology, Kyoto University Hospital
Kyoto, Kyoto, 6066-8507
About this study
The purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary artery disease.
Read the detailed description
Antihypertensive therapy is reported to reduce cardiovascular events in patients with coronary artery disease. The goal of blood pressure in patients with coronary artery disease is recommended to control below 140/90mmHg. However, the effect of intensive blood pressure control compared to standard blood pressure control is still unknown. The purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary atherosclerosis after 18 months. The goal of systolic blood pressure is under 120mmHg in intensive blood pressure control group and under 140mmHg in standard blood pressure control group. The design of this study is randomized control study.
- Conditions
- Coronary Artery Disease, Hypertension
- Being tested
- control systolic blood pressure less than 120 mmHg, control systolic blood pressure less than 140 mmHg
- Keywords
- coronary artery disease, hypertension
- Medical subject headings
- Coronary Artery Disease, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control systolic blood pressure less than 120 mmHgDrug
use losartan to control blood pressure
control systolic blood pressure less than 140 mmHgDrug
use losartan to control blood pressure
| Study group | Role | What they receive |
|---|---|---|
| intensive blood pressure control | Active comparator | systolic blood pressure less than 120 mmHg Receives: Drug: control systolic blood pressure less than 120 mmHg |
| standard blood pressure control | Active comparator | systolic blood pressure less than 140 mmHg Receives: Drug: control systolic blood pressure less than 140 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of percent atheroma volume
change of percent atheroma volume measured by intravascular ultrasound
Measured: 1.5-year
Secondary outcomes (12)
all cause death
Death from any cause
Measured: 1.5-year
cardiac death
Death from cardiac diseases
Measured: 1.5-year
cardiovascular death
Death from cardiovascular diseases
Measured: 1.5-year
myocardial infarction
myocardial infarction defined by ARC
Measured: 1.5-year
stroke
both ischemic and hemorrhagic strokes excluding transient ischemic attack
Measured: 1.5-year
target-lesion revascularization
target-lesion revascularization
Measured: 1.5-year
any coronary revascularization
any coronary revascularization
Measured: 1.5-year
hospitalization due to angina pectoris
hospitalization due to angina pectoris
Measured: 1.5-year
hospitalization due to heart failure
hospitalization due to heart failure
Measured: 1.5-year
change of total atheroma volume
change of total atheroma volume measured by intravascular ultrasond
Measured: 1.5-year
percent change of total atheroma volume
percent change of total atheroma volume measured by intravascular ultrasound
Measured: 1.5-year
change of atheroma volume at most severe 10mm lesion
change of atheroma volume at most severe 10mm lesion measured by intravascular ultrasound
Measured: 1.5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2015
- Study completionApr 2015
Why it stopped: Slow patients enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeshi Morimoto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Takeshi Morimoto, Kyoto University, Graduate School of Medicine
- Investigators
- Takeshi Kimura, MD, PhD, Principal investigator, Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230216
- Sponsor's protocol ID
- C464
- Acronym
- PREVUS
- Status last verified
- Jan 2016
- First submitted
- 28 Oct 2010
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
PubMed 36398903Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.
PubMed 32905623
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
- ClinicalTrials.gov ID
- NCT01230216
- Acronym / sponsor ID
- PREVUS / C464
- Conditions
- Coronary Artery Disease, Hypertension
- Keywords
- coronary artery disease, hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow patients enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Takeshi MorimotoUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 Oct 2010 (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.
The purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary artery disease.
Detailed description
Antihypertensive therapy is reported to reduce cardiovascular events in patients with coronary artery disease. The goal of blood pressure in patients with coronary artery disease is recommended to control below 140/90mmHg. However, the effect of intensive blood pressure control compared to standard blood pressure control is still unknown. The purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary atherosclerosis after 18 months. The goal of systolic blood pressure is under 120mmHg in intensive blood pressure control group and under 140mmHg in standard blood pressure control group. The design of this study is randomized control study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intensive blood pressure control | Active comparator | Drug: control systolic blood pressure less than 120 mmHgsystolic blood pressure less than 120 mmHg |
| standard blood pressure control | Active comparator | Drug: control systolic blood pressure less than 140 mmHgsystolic blood pressure less than 140 mmHg |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- coronary artery diseases which require coronary angiography or percutaneous coronary intervention
- primary hypertension (systolic blood pressure 140-180mmHg within one month)
Key exclusion criteria (7 listed)
- severe hypertension
- secondary hypertension
- treated with more than three antihypertensive drugs
- left main trunk trunk coronary artery disease
- moderate heart failure
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 |
|---|---|---|
| control systolic blood pressure less than 120 mmHguse losartan to control blood pressure | Drug | intensive blood pressure control |
| control systolic blood pressure less than 140 mmHguse losartan to control blood pressure | Drug | standard blood pressure control |
Primary outcome
change of percent atheroma volume
Time frame: 1.5-year
change of percent atheroma volume measured by intravascular ultrasound
12 secondary outcomes
all cause death
Time frame: 1.5-year
cardiac death
Time frame: 1.5-year
cardiovascular death
Time frame: 1.5-year
myocardial infarction
Time frame: 1.5-year
stroke
Time frame: 1.5-year
target-lesion revascularization
Time frame: 1.5-year
any coronary revascularization
Time frame: 1.5-year
hospitalization due to angina pectoris
Time frame: 1.5-year
hospitalization due to heart failure
Time frame: 1.5-year
change of total atheroma volume
Time frame: 1.5-year
percent change of total atheroma volume
Time frame: 1.5-year
change of atheroma volume at most severe 10mm lesion
Time frame: 1.5-year
Results and safety
The study was stopped early (reason given: Slow patients enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Derived from this study: PubMed 36398903Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
- Derived from this study: PubMed 32905623Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Takeshi Kimura, MD, PhD principal investigator
Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
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 of Coronary Artery Disease and Hypertension, run by Takeshi Morimoto at 1 site in Japan.
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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 11 Jan 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 Japan. 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. 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 was stopped early (reason given: Slow patients enrollment). Results are not available in the source record.
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 of percent atheroma volume (time frame: 1.5-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01230216, which also lists 2 linked publications.
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 11 Jan 2016.