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| Name | Class |
|---|---|
| InCor Heart Institute | OTHER |
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Cardiovascular events are the main cause of mortality in diabetic patients ,on the other hand,during an acute myocardial infarction(AMI),hyperglycemia increases mortality and is related to different pathophysiologic processes.
More important evidence regarding the effect of glycemic control on AMI patients prognosis is contradictory,and the potential benefits of dipeptidyl peptidase-4 inhibitors(DPP4-i) in this setting is unknown.
The aim of this study is to assess the presence of pleiotropic effects of DPP4-i(sitagliptin or saxagliptin) and their relationship with glycemic control during in-hospital phase of AMI.
Randomized clinical trial,double-blinded,placebo-controlled, in a single center, to assess the influence of DPP4-i on platelet aggregability in type 2 diabetic patients with acute myocardial infarction in use of dual anti platelet therapy (DAPT) .
Others exploratory analysis include:glycemic control ,infarct size,genetic analysis and cholesterol metabolism.
After giving signed informed consent,eligible subjects will be randomly allocated to receive saxagliptin or placebo, in the first 48 hours (+-24) after the beginning of an AMI.
The investigator and subjects will be blinded to trial treatment,and a person not involved in trial conduct will prepare the doses of study drug.The doses will be administered by mouth,in a once daily basis by the investigator.
Blood samples will be collected by the investigator according to pre-specified outcomes and time frames.
Evaluation of glycemic control by CGM will be carried out by the investigator,including insert and withdrawal of the device.
Treatment of the acute event,(AMI) will be done according to routine procedures from coronary care unit.
Serious adverse event report taking into consideration all-cause mortality, cardiovascular mortality, hospitalization for heart failure and pancreatitis, will be done according to presence of these events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment: DPP4 -i | Active Comparator | Use of DPP4-i : sitagliptin 50 mg (if glomerular filtration rate-GFR <50 ml/min at randomization) or 100 mg (if GFR>50 ml/min at randomization),during 30 days,once-daily(OD) OR saxagliptin 2,5 mg (if glomerular filtration rate-GFR <50 ml/min at randomization) or 5 mg (if GFR>50 ml/min at randomization),during 30 days,once-daily(OD) |
|
| control | Placebo Comparator | placebo tablets identical to active comparator,administered according to GFR at randomization,during 30 days,OD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin OR saxagliptin | Drug | sitagliptin OR saxagliptin tablets, 48(+-24) hours after the beginning of an AMI,and both arms in use of dual anti-platelet therapy (DAPT) . |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes on platelet aggregability. | Comparison on platelet function between two therapeutic arms in a double-blind randomized fashion. Platelet aggregability will be measured 4(+-2) days after drug exposure,using a point-of-care test (VerifyNow Aspirin) in type 2 diabetic patients with AMI on dual antiplatelet therapy (ASA+ ticagrelor or clopidogrel according to institutional routine). | baseline and 4(+-2) days after drug exposure. |
| Measure | Description | Time Frame |
|---|---|---|
| changes on platelet aggregability. | Primary outcome measure analyzed at baseline and 30(+-5) days after drug exposure. | baseline and 30(+-5) days after drug exposure. |
| platelet aggregability differences by two point-of-care methods. |
| Measure | Description | Time Frame |
|---|---|---|
| changes in glycemic control(glycemic variability assessed by standard deviation(SD) of capillary glucose samples). | Evaluated by measurements of capillary glucose samples by point-of care test during the length of coronary care unit(CCU) stay( expected average of 1 week).The glycemic variability will be obtained by calculating the standard deviation(SD). | baseline up to 1 week. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose C Nicolau, MD,PhD | Heart Institute(InCor)-University of São Paulo GH-Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute(InCor)-Acute Coronary Care Unit | São Paulo | São Paulo | 01406000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15939812 | Background | Kosiborod M, Rathore SS, Inzucchi SE, Masoudi FA, Wang Y, Havranek EP, Krumholz HM. Admission glucose and mortality in elderly patients hospitalized with acute myocardial infarction: implications for patients with and without recognized diabetes. Circulation. 2005 Jun 14;111(23):3078-86. doi: 10.1161/CIRCULATIONAHA.104.517839. Epub 2005 Jun 6. | |
| 18268145 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 22, 2022 | |
| Unrelease | Sep 7, 2022 | |
| Release | Sep 8, 2022 | |
| Unrelease | Sep 18, 2022 | |
| Release | Sep 19, 2022 | |
| Reset | Aug 7, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 22, 2022 | Sep 7, 2022 | |||
| Sep 8, 2022 | Sep 18, 2022 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| C502994 | saxagliptin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| placebo | Drug | placebo tablets, 48(+-24) hours after the beginning of an AMI,and both arms in use of dual anti-platelet therapy (DAPT) . |
|
|
Comparison on platelet aggregability by two different methods :Verify Now and Multiplate.
| baseline and 4 (+-2) days after drug exposure. |
| platelet aggregability differences by two point-of-care methods. | Comparison on platelet aggregability by two different methods (Verify Now and Multiplate . | baseline and 30(+-5) days after drug exposure. |
| changes in glycemic control(glycemic variability assessed by continuous glucose monitoring system - CGM). | Evaluated by mean amplitude of glycemic excursions(MAGE) by the use of CGM | baseline and 48 (+-24) hours after drug exposure. |
| changes on platelet aggregability on pre-specified subgroups. | Changes on platelet aggregability will be compared on pre-specified subgroups: elderly (age >65 yrs-old) versus non-elderly; male versus female; smoking versus non-smoking patients; obese(BMI>30 Kg/m2) versus non-obese; length of diabetes; baseline glucose; glycated hemoglobin(HbA1c) < 9% and >9 % | baseline and 4 (+-2)days after drug exposure. |
| rate of hypoglycemia during coronary care unit stay. | Rate of capillary glucose <70 mg/dL and <40 mg/dL,evaluated by capillary glucose measurements by point-of-care tests,during CCU stay(expected average of 1 week). | baseline up to 1 week . |
| total of insulin doses requirement during coronary care unit stay. | Comparison of the total requirement of correctional insulin between treatment and control arms after drug exposure. | baseline up to 1 week . |
| incidence of composite end-point. | Comparison the incidence of composite end-point between two arms.Composite end-point include: cardiovascular death; unstable angina; stroke ; hospitalization for heart failure; new non fatal myocardial infarction ; coronary revascularization . | baseline and 30 (+-5) days after drug exposure |
| Infarct size. | Analysis of infarct size between two arms, by peak of creatine kinase(CK-MB) during CCU stay(expected average of 1 week). | baseline up to 1 week |
| cholesterylester transfer protein(CETP) mass | Analysis of CETP mass between two arms. | baseline |
| measure of safety, Number of participants with adverse effects by analysis on changes of serum level | Number of participants with adverse effects by analysis on changes of serum level of : alanine transferase; brain natriuretic peptide(BNP); amylase; lipase. | baseline and 30(+-5) days after drug exposure. |
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| Sep 19, 2022 | Aug 7, 2023 |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D011719 |
| Pyrazines |