Platelet Aggregation During Acute Myocardial Infarction Clinical Trial
Official title:
DPP-4 Inhibitors in Patients With Type 2 Diabetes and Acute Myocardial Infarction:Effects on Platelet Function
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.
;