Type 2 DiabetesPhase 4NCT01422421
Intensive Blood Pressure and LDL Lowering in Diabetic Patients With Coronary Artery Disease
A Phase 4 study of Type 2 Diabetes and Coronary Artery Disease, run by Takeshi Morimoto at 2 sites in Japan.
Trial summary
The purpose of this study is to determine whether intensive blood pressure and low density lipoprotein (LDL) cholesterol lowering could improve survival and cardiovascular outcome in Japanese diabetic patients with coronary artery disease and history of acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes, Coronary Artery Disease, Hypertension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 798 participants
- Where
- 2 sitesJapan
- Study dates
- Aug 2011to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients with coronary artery disease and history of acute coronary syndrome
- Patients whose blood pressure and LDL cholesterol levels are above values recommended by the current guideline
Who cannot join
- Patients who have active malignant tumor
- Patients who are on hemodialysis due to end stage kidney disease
- Patients whom statins are contraindicated
- Patients who had acute coronary syndrome or stroke within 3 months
- Patients who are pregnant or on breast feeding
- Patients whose physicians deem that attending this trial is contraindicated or inappropriate
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
University Hospital, University of the Ryukyus
Nishihara, Okinawa, 903-0215
Saga University Hospital
Saga, 849-8501
About this study
Official title: Intensive Blood Pressure and LDL Lowering for Better Survival and Cardiovascular Outcome in Diabetic Patients With Coronary Artery Disease: Randomized Controlled Trial
The purpose of this study is to determine whether intensive blood pressure and low density lipoprotein (LDL) cholesterol lowering could improve survival and cardiovascular outcome in Japanese diabetic patients with coronary artery disease and history of acute coronary syndrome.
Read the detailed description
Prevalence of type 2 diabetes in Asia seems to be almost epidemic and establishment of preventive strategy against macrovascular as well as microvascular diseases are warranted because of higher cardiovascular risk in diabetic patients even without history of atherosclerotic cardiovascular diseases. Benefit of lowering low density lipoprotein (LDL) cholesterol down to 70 mg/ml in Caucasian patients with coronary artery disease (CAD) has been well established but not in Asian patients with lower risk of myocardial infarction and higher stroke risk. Intensive lowering blood pressure for cardiovascular outcome in diabetic patients and patients with CAD has been recommended in several guidelines without firm evidence. Risk and benefit of intensive blood pressure and LDL control should be evaluated in Japanese diabetic CAD patients by pragmatic randomized controlled trial.
- Conditions
- Type 2 Diabetes, Coronary Artery Disease, Hypertension, Dyslipidemia
- Being tested
- intensive control, standard control
- Keywords
- type 2 diabetes, coronary artery disease, hypertension, dyslipidemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Artery Disease, Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive controlOther
use any medication to achieve systolic blood pressure less than 120mmHg and LDL cholesterol within 70-85mg/dl
standard controlOther
use any medication to achieve systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl
| Study group | Role | What they receive |
|---|---|---|
| intensive control | Active comparator | systolic blood pressure less than 120mmHg and LDL cholesterol within 70- 85mg/dl Receives: Other: intensive control |
| standard control | Active comparator | systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl Receives: Other: standard control |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite endpoint
composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and unstable angina requiring hospital administration
Measured: 3 years
important secondary composite endpoint
composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospital administration, and admission for heart failure
Measured: 3 years
Secondary outcomes (7)
all-cause mortality
death due to any cause
Measured: 3 years
myocardial infarction
non fatal myocardial infarction
Measured: 3 years
stroke
non fatal stroke excluding transient ischemic attack
Measured: 3 years
Cardiovascular death
Cardiovascular death
Measured: 3 years
end stage renal disease
end stage renal disease needs kidney transplantation or hemodialysis
Measured: 3 years
peripheral artery disease
peripheral artery disease
Measured: 3 years
new onset or deterioration of heart failure
new onset or deterioration of heart failure
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startAug 2011
- Primary completion31 Mar 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 798 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeshi Morimoto
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Ryukyus
- Responsible party
- Sponsor-investigator, Takeshi Morimoto, Kyoto University, Graduate School of Medicine
- Investigators
- Shinichiro Ueda, MD, PhD, Principal investigator, Professor of Clinical Pharmacology and Therapeutics, University of the Ryukyus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422421
- Sponsor's protocol ID
- H21-rinsho shiken ippan-017
- Status last verified
- Jun 2024
- First submitted
- 23 Aug 2011
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Blood Pressure and LDL Lowering for Better Survival and Cardiovascular Outcome in Diabetic Patients With Coronary Artery Disease: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01422421
- Acronym / sponsor ID
- H21-rinsho shiken ippan-017
- Conditions
- Type 2 Diabetes, Coronary Artery Disease, Hypertension, Dyslipidemia
- Keywords
- type 2 diabetes, coronary artery disease, hypertension, dyslipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 798 participants (actual)
- Lead sponsor
- Takeshi MorimotoUniversity, hospital or other
- Collaborators
- University of the Ryukyus
- Study start
- Aug 2011
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Aug 2011 (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 determine whether intensive blood pressure and low density lipoprotein (LDL) cholesterol lowering could improve survival and cardiovascular outcome in Japanese diabetic patients with coronary artery disease and history of acute coronary syndrome.
Detailed description
Prevalence of type 2 diabetes in Asia seems to be almost epidemic and establishment of preventive strategy against macrovascular as well as microvascular diseases are warranted because of higher cardiovascular risk in diabetic patients even without history of atherosclerotic cardiovascular diseases. Benefit of lowering low density lipoprotein (LDL) cholesterol down to 70 mg/ml in Caucasian patients with coronary artery disease (CAD) has been well established but not in Asian patients with lower risk of myocardial infarction and higher stroke risk. Intensive lowering blood pressure for cardiovascular outcome in diabetic patients and patients with CAD has been recommended in several guidelines without firm evidence. Risk and benefit of intensive blood pressure and LDL control should be evaluated in Japanese diabetic CAD patients by pragmatic randomized controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intensive control | Active comparator | Other: intensive controlsystolic blood pressure less than 120mmHg and LDL cholesterol within 70- 85mg/dl |
| standard control | Active comparator | Other: standard controlsystolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetic patients with coronary artery disease and history of acute coronary syndrome
- Patients whose blood pressure and LDL cholesterol levels are above values recommended by the current guideline
Key exclusion criteria (6 listed)
- Patients who have active malignant tumor
- Patients who are on hemodialysis due to end stage kidney disease
- Patients whom statins are contraindicated
- Patients who had acute coronary syndrome or stroke within 3 months
- Patients who are pregnant or on breast feeding
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 |
|---|---|---|
| intensive controluse any medication to achieve systolic blood pressure less than 120mmHg and LDL cholesterol within 70-85mg/dl | Other | intensive control |
| standard controluse any medication to achieve systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl | Other | standard control |
Primary outcome
composite endpoint
Time frame: 3 years
composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and unstable angina requiring hospital administration
important secondary composite endpoint
Time frame: 3 years
composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospital administration, and admission for heart failure
7 secondary outcomes
all-cause mortality
Time frame: 3 years
myocardial infarction
Time frame: 3 years
stroke
Time frame: 3 years
Cardiovascular death
Time frame: 3 years
end stage renal disease
Time frame: 3 years
peripheral artery disease
Time frame: 3 years
new onset or deterioration of heart failure
Time frame: 3 years
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 Jun 2024.
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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.
Shinichiro Ueda, MD, PhD principal investigator
Professor of Clinical Pharmacology and Therapeutics, University of the Ryukyus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Type 2 Diabetes and Coronary Artery Disease, run by Takeshi Morimoto at 2 sites 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 6 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 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
composite endpoint (time frame: 3 years). 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 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.