| Trial ID: | L6100 |
| Source ID: | NCT05998525
|
| Associated Drug: |
Dapagliflozin 10mg Tab
|
| Title: |
Dapagliflozin Effects on Coronary Calcium and Epicardial Fat Assessed by Cardiotomography
|
| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Diabete Type 2|Unstable Angina|Myocardial Infarction|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Dapagliflozin 10Mg Tab|DRUG: Placebo
|
| Outcome Measures: |
Primary: Changes in the coronary calcium score quantified by Agatston's score using simple coronary tomography. Quantified in agatston units (AU), Standardized categories have been developed for the calcium score with scores of 0 indicating the absence of calcified plaque, 1 to 10 minimal plaque, 11 to 100 mild plaque, 101 to 400 moderate plaque, and \> 400 severe plaque. This is evaluated by the Agatston score. cardiac tomography will be performed on admission prior to hospital discharge and after 12 months of treatment in both groups., A baseline tomography will be performed at the time of randomization and at 12 months of follow-up.|changes in cardiac epicardial fat volume quantified in cm3 and evaluated by simple cardiac tomography., Visceral fat depot of the heart and can secrete bioactive molecules that have modulatory effects on the myocardium. Cardiac tomography will be performed on admission prior to hospital discharge and after 12 months of treatment in both groups., A baseline tomography will be performed at the time of randomization and at 12 months of follow-up. | Secondary: Number of patients with progression of atherosclerotic disease. The increase in coronary calcium and the increase in epicardial fat after 12 months of treatment will be considered as progression., Determine changes in the total burden of atherosclerotic disease with the use of Dapagliflozin, A baseline tomography will be performed at the time of randomization and at 12 months of follow-up.|Number of patients with new event of acute myocardial infarction, Determine the association of the coronary calcium score on the development of acute myocardial infarction in both study groups, 12 months|Number of patients with new event of unstable angina, Determine the association of the coronary calcium score on the development of unstable angina in both study groups, 12 months|Mortality due to cardiovascular causes, During the follow-up of the study, the cause of cardiovascular origin will be taken as that related to acute myocardial infarction or worsening of heart failure, 12 months
|
| Sponsor/Collaborators: |
Sponsor: Hilda Elizabeth Macías Cervantes
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
|
| Enrollment: |
54
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2021-06-21
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| Completion Date: |
2023-06-01
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| Results First Posted: |
|
| Last Update Posted: |
2023-08-21
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| Locations: |
Unidad Medica de Alta Especialidad No. 1, Bajío, Leon, Guanajuato, 37260,, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT05998525
|
