Effects of dapaglifloziN Therapy on Myocardial Perfusion Reserve in Prediabetic Patients With Stable coronarY Artery Disease
NCT ID: NCT04330079
Last Updated: 2022-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
2 participants
INTERVENTIONAL
2020-05-21
2021-04-08
Brief Summary
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Dapagliflozin therapy versus lifestyle modification improves myocardial perfusion reserve in prediabetic patients with stable CAD.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dapagliflozin
Dapagliflozin 10mg
Dapagliflozin 10mg once daily for 6 months.
Lifestyle modification
Lifestyle modification
lifestyle modification (diet and exercise) for 6 months
Interventions
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Dapagliflozin 10mg
Dapagliflozin 10mg once daily for 6 months.
Lifestyle modification
lifestyle modification (diet and exercise) for 6 months
Eligibility Criteria
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Inclusion Criteria
2. Prediabetes by ADA criteria (fasting glucose 100-125mg/dl, or HbA1C 5.7-6.4%)
3. Stable coronary artery disease
4. Global myocardial perfusion reserve (MPR) index \< 2.0
5. 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.
Exclusion Criteria
2. Significant renal disease manifested by eGFR\<30 ml/min/1.73m²
3. Unstable or rapidly progressing renal disease
4. Acute coronary syndrome, or any other major cardiovascular events within the previous 6 months
5. Stent placement, or coronary artery bypass graft surgery within the previous 6 months
6. Planned revascularization within 6 months
7. Significant disease (diameter stenosis \>70% by coronary CT angiography) in major epicardial coronary arteries
8. Heart failure requiring loop diuretics
9. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal).
10. Contraindication to adenosine stress test
11. Current treatment for the active cancer
12. 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.
13. Expected life expectancy \< 1 year
14. 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.
15. Unwillingness or inability to comply with the procedures described in this protocol.
18 Years
ALL
No
Sponsors
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CHEOL WHAN LEE, M.D., Ph.D
OTHER
Responsible Party
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CHEOL WHAN LEE, M.D., Ph.D
Professor
Principal Investigators
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Cheol Whan Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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ENTRY trial
Identifier Type: -
Identifier Source: org_study_id
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