Coronary Artery DiseasePhase 4NCT04330079
Effects of dapaglifloziN Therapy on Myocardial Perfusion Reserve in Prediabetic Patients With Stable coronarY Artery Disease
A Phase 4 study testing Dapagliflozin 10mg and Lifestyle modification in people with Coronary Artery Disease and Prediabetic State, run by CHEOL WHAN LEE, M.D., Ph.D at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the effects of dapagliflozin therapy on myocardial perfusion reserve (MPR) using dynamic SPECT examination in prediabetic patients with stable CAD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Prediabetic State
- What is being tested?
- Dapagliflozin 10mg and Lifestyle modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 May 2020to 8 Apr 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women at least 18 years of age
- Prediabetes by ADA criteria (fasting glucose 100-125mg/dl, or HbA1C 5.7-6.4%)
- Stable coronary artery disease
- Global myocardial perfusion reserve (MPR) index < 2.0
- The patient or guardian agrees to the study protocol and the schedule of clinical and dynamic SPECT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Who cannot join
- Contraindications to dapagliflozin
- Significant renal disease manifested by eGFR<30 ml/min/1.73m²
- Unstable or rapidly progressing renal disease
- Acute coronary syndrome, or any other major cardiovascular events within the previous 6 months
- Stent placement, or coronary artery bypass graft surgery within the previous 6 months
- Planned revascularization within 6 months
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- Significant disease (diameter stenosis >70% by coronary CT angiography) in major epicardial coronary arteries
- Heart failure requiring loop diuretics
- Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
- Contraindication to adenosine stress test
- Current treatment for the active cancer
- Women of child bearing potential who are not willing to use a medically accepted method of contraception. Patient's pregnancy confirmed by positive pregnancy test, or breast-feeding.
- Expected life expectancy < 1 year
- Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests which, in the judgment of the investigator, would preclude safe completion of the study.
- 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: Effects of dapaglifloziN Therapy on Myocardial Perfusion Reserve in Prediabetic Patients With Stable coronarY Artery Disease (ENTRY Trial)
The purpose of this study is to investigate the effects of dapagliflozin therapy on myocardial perfusion reserve (MPR) using dynamic SPECT examination in prediabetic patients with stable CAD.
Dapagliflozin therapy versus lifestyle modification improves myocardial perfusion reserve in prediabetic patients with stable CAD.
- Conditions
- Coronary Artery Disease, Prediabetic State
- Being tested
- Dapagliflozin 10mg, Lifestyle modification
- Keywords
- Dapagliflozin, Lifestyle modification, Myocardial perfusion reserve
- Medical subject headings
- Coronary Artery Disease, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mgDrug
Dapagliflozin 10mg once daily for 6 months.
Lifestyle modificationOther
lifestyle modification (diet and exercise) for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Not described Receives: Drug: Dapagliflozin 10mg |
| Lifestyle modification | Other | Not described Receives: Other: Lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in global myocardial perfusion reserve (MPR) index
Measured: 6months
Secondary outcomes (5)
Percent change in regional myocardial perfusion reserve (MPR) index
Measured: 6months
absolute changes in global MPR index
Measured: 6months
absolute changes in regional MPR index
Measured: 6months
Change in body weight
Measured: 6months
Change in blood pressure(systolic, diastolic both )
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start21 May 2020
- Primary completion8 Apr 2021
- Study completion8 Apr 2021
Why it stopped: Slow enrollment. (Difficulty in selecting subjects)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHEOL WHAN LEE, M.D., Ph.D
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center
- Investigators
- Cheol Whan Lee, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330079
- Sponsor's protocol ID
- ENTRY trial
- Status last verified
- Sep 2022
- First submitted
- 30 Mar 2020
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of dapaglifloziN Therapy on Myocardial Perfusion Reserve in Prediabetic Patients With Stable coronarY Artery Disease (ENTRY Trial)
- ClinicalTrials.gov ID
- NCT04330079
- Acronym / sponsor ID
- ENTRY trial
- Conditions
- Coronary Artery Disease, Prediabetic State
- Keywords
- Dapagliflozin, Lifestyle modification, Myocardial perfusion reserve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment. (Difficulty in selecting subjects)
- Enrolment
- 2 participants (actual)
- Lead sponsor
- CHEOL WHAN LEE, M.D., Ph.DUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 1 Apr 2020 (actual)
- 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 investigate the effects of dapagliflozin therapy on myocardial perfusion reserve (MPR) using dynamic SPECT examination in prediabetic patients with stable CAD.
Dapagliflozin therapy versus lifestyle modification improves myocardial perfusion reserve in prediabetic patients with stable CAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin 10mg |
| Lifestyle modification | Other | Other: Lifestyle modification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women at least 18 years of age
- Prediabetes by ADA criteria (fasting glucose 100-125mg/dl, or HbA1C 5.7-6.4%)
- Stable coronary artery disease
- Global myocardial perfusion reserve (MPR) index < 2.0
- The patient or guardian agrees to the study protocol and the schedule of clinical and dynamic SPECT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Key exclusion criteria (15 listed)
- Contraindications to dapagliflozin
- Significant renal disease manifested by eGFR<30 ml/min/1.73m²
- Unstable or rapidly progressing renal disease
- Acute coronary syndrome, or any other major cardiovascular events within the previous 6 months
- Stent placement, or coronary artery bypass graft surgery within the previous 6 months
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 |
|---|---|---|
| Dapagliflozin 10mgDapagliflozin 10mg once daily for 6 months. | Drug | Dapagliflozin |
| Lifestyle modificationlifestyle modification (diet and exercise) for 6 months | Other | Lifestyle modification |
Primary outcome
Percent change in global myocardial perfusion reserve (MPR) index
Time frame: 6months
5 secondary outcomes
Percent change in regional myocardial perfusion reserve (MPR) index
Time frame: 6months
absolute changes in global MPR index
Time frame: 6months
absolute changes in regional MPR index
Time frame: 6months
Change in body weight
Time frame: 6months
Change in blood pressure(systolic, diastolic both )
Time frame: 6months
Results and safety
The study was stopped early (reason given: Slow enrollment. (Difficulty in selecting subjects)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
Cheol Whan Lee, MD, PhD 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 Dapagliflozin 10mg and Lifestyle modification in people with Coronary Artery Disease and Prediabetic State, run by CHEOL WHAN LEE, M.D., Ph.D 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 5 inclusion and 15 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 23 Sep 2022. 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. 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 enrollment. (Difficulty in selecting subjects)). 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?
Percent change in global myocardial perfusion reserve (MPR) index (time frame: 6months). 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 23 Sep 2022.