| Trial ID: | L5487 |
| Source ID: | NCT05392959
|
| Associated Drug: |
Dapagliflozin 10 Mg Tab
|
| Title: |
Effect of the Antidiabetic Drug Dapagliflozin on the Coronary Macrovascular and Microvascular Function in Type 2 Diabetic Patients
|
| Acronym: |
DAPAMICRO
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| Status: |
TERMINATED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Dapagliflozin 10 mg Tab|DRUG: Placebo
|
| Outcome Measures: |
Primary: the longitudinal change of the Fractional Flow Reserve (FRR), The longitudinal change (Δ) of FFR is defined as the value at follow-up (6 months) minus the value at baseline. The complete assessment of the function of the coronary circulation will be performed by using a dedicated pressure and temperature equipped coronary guidewire (PressureWire X by Abbott Vascular) and the Coroventis CoroFlow software platform. In the presence of coronary lesions, the degree of percent diameter stenosis will be measured by quantitative coronary angiography and their hemodynamic significance will be evaluated by measuring fractional flow reserve (FFR). According to the guidelines for myocardial revascularisation, only the lesions that have an FFR value equal or less than 0.8 will be treated by coronary angioplasty . In case of angioplasty, FFR will be also measured immediately after successful implantation of the coronary stent., up to 6 months|the longitudinal change of the Coronary flow reserve (CFR), The longitudinal change (Δ) of CFR is defined as the value at follow-up (6 months) minus the value at baseline. The complete assessment of the function of the coronary circulation will be performed by using a dedicated pressure and temperature equipped coronary guidewire (PressureWire X by Abbott Vascular) and the Coroventis CoroFlow software platform. Coronary flow reserve (CFR) will be measured in the vessels of interest, where FFR was measured., up to 6 months|the longitudinal change of the Index of Microvascular Resistance (IMR)., The longitudinal change (Δ) of IMR is defined as the value at follow-up (6 months) minus the value at baseline. The complete assessment of the function of the coronary circulation will be performed by using a dedicated pressure and temperature equipped coronary guidewire (PressureWire X by Abbott Vascular) and the Coroventis CoroFlow software platform. The Index of Microvascular Resistance (IMR) will be measured in the vessels of interest, where FFR was measured., up to 6 months |
|
| Sponsor/Collaborators: |
Sponsor: Centre Hospitalier Universitaire Saint Pierre | Collaborators: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
|
| Enrollment: |
4
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-06-06
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| Completion Date: |
2023-07-17
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| Results First Posted: |
|
| Last Update Posted: |
2024-04-26
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| Locations: |
CHU Saint Pierre, Brussels, Bruxelles-Capitale, Région de;Brussels Hoofdstedelijk Gewest, 1000, Belgium
|
| URL: |
https://clinicaltrials.gov/show/NCT05392959
|
