Coronary macrovascular and microvascular function of type 2 diabetic patients with stable coronary artery disease and acute coronary syndrome (excluding ST elevation myocardial infarction).
Conditions
Interventions
Trade Name: Forxiga
Pharmaceutical Form: Tablet
INN or Proposed INN: Dapagliflozin
CAS Number: 461432-26-8
Other descriptive name: propylène glycol monohydraté de dapagliflozine
Concentration unit: kB
Sponsors
CHU Saint Pierre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. T2DM patients presenting with stable angina and a clinical indication for cardiac catheterization 2. T2DM patients with NSTEMI or unstable angina referred for cardiac catheterization 3. Demonstration of coronary lesion(s) with non-significant fractional flow reserve (FFR) values (>0.80), for which revascularisation is deferred 4. Agreement to practice an acceptable method of birth control for women of childbearing potential 5. Signed patient informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Age 240 mg/dL after an overnight fast 7. Stroke, or transient ischemic attack within 2 months prior to informed consent 8. Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake 9. Any uncontrolled endocrine disorder except type 2 diabetes 10. Treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent 11. Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at time of screening leading to unstable body weight 12. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 2 years 13. Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells 14. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption 15. Planned cardiac surgery or angioplasty within 3 months 16. Any clinical condition that would jeopardize patient safety while participating in this clinical trial (in Canada, this included current genito-urinal infection or genito-urinal infection within 2 weeks prior to informed consent) 17. Life expectancy < 3 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of dapagliflozin [sodium-glucose linked transporter 2 (SGLT2) inhibitor] on: 1.The coronary flow reserve (CFR) 2.The physiology of coronary macrocirculation (epicardial coronary segments), as measured by fractional flow reserve (FFR) 3.The physiology of the coronary microcirculation, as measured by the index of microvascular resistance (IMR). in T2DM patients with stable CAD or ACS (excluding STEMI) referred for coronary angiography. For NSTEMI or unstable angina ACS patients, the non-culprit vessels will be interrogated. ;Secondary Objective: "Not applicable";Primary end point(s): The objective is to determine the effects of dapaglifozin and the standard of care on the longitudinal change of CFR, FFR and IMR. The longitudinal change (?) is defined as the value at follow-up (6 months) minus the value at baseline. Comparisons between the study arms, using the standard of care as a comparator will be made, in order to explore the relative effect of drugs on the physiology of the coronary macro and microcirculation. ;Timepoint(s) of evaluation of this end point: 6 months after enrolment in the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Belgium
Contacts
Public ContactDr Panagiotis Xaplanteris
CHU Saint Pierre
Outcome results
None listed