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Clinical Trial Details

Trial ID: L6283
Source ID: NCT02377388
Associated Drug: Sitagliptin Or Saxagliptin
Title: DPP-4 Inhibitors and Acute Myocardial Infarction:Effects on Platelet Function
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Platelet Aggregation During Acute Myocardial Infarction
Interventions: DRUG: sitagliptin OR saxagliptin|DRUG: placebo
Outcome Measures: Primary: 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. | Secondary: 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., 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. | Other: 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.|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.
Sponsor/Collaborators: Sponsor: University of Sao Paulo General Hospital | Collaborators: InCor Heart Institute
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 74
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-02-07
Completion Date: 2020-02-28
Results First Posted:
Last Update Posted: 2020-08-28
Locations: Heart Institute(InCor)-Acute Coronary Care Unit, São Paulo, SP, 01406000, Brazil
URL: https://clinicaltrials.gov/show/NCT02377388