NCT02377388

DPP-4 Inhibitors and Acute Myocardial Infarction:Effects on Platelet Function

DPP-4 Inhibitors in Patients With Type 2 Diabetes and Acute Myocardial Infarction:Effects on Platelet Function

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Platelet Aggregation During Acute Myocardial Infarction

Interventions

Type	Name	Description
DRUG	sitagliptin OR saxagliptin	sitagliptin OR saxagliptin tablets, 48(+-24) hours after the beginning of an AMI,and both arms in use of dual anti-platelet therapy (DAPT) .
DRUG	placebo	placebo tablets, 48(+-24) hours after the beginning of an AMI,and both arms in use of dual anti-platelet therapy (DAPT) .

Timeline

• Start date: 2017-02-07
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2015-03-03
• Last updated: 2020-08-28

Locations

1 site across 1 country: Brazil