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NCT Number: NCT02377388

DPP-4 Inhibitors 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.

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Key information

Conditions

Platelet Aggregation During Acute Myocardial Infarction Acute Coronary Syndrome Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Heart Institute(InCor)-Acute Coronary Care Unit

São Paulo, 01406000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • previous diagnosis of type 2 diabetes mellitus,with treatment including insulin and/or oral antidiabetic agent;
  • subjects without previous diagnosis of diabetes,but HbA1c admission >= 6,5% during current hospital-stay
  • AMI with or without ST-elevation;
  • use of double antiplatelet therapy;
  • signed informed consent term

Exclusion criteria

  • GFR <30 ml/min;
  • use of DPP4 inhibitors or glucagon- like peptide-1(GLP1) analogue in the past 6 months;
  • use of strong inhibitors of cytochrome P450(CYP3A4/5) ou glucocorticoids;
  • severe systemic decompensation requiring insulin infusion;
  • Killip classification of myocardial infarction grade >2;
  • previous history of pancreatitis

Treatment and study plan

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) .

Other names: januvia ® OR onglyza ®

Placebo

Drug

placebo tablets, 48(+-24) hours after the beginning of an AMI,and both arms in use of dual anti-platelet therapy (DAPT) .

Other names: PBO

Primary outcomes

  1. changes on platelet aggregability.

    Time frame: baseline and 4(+-2) days after drug exposure.

    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).

Secondary outcomes

  1. changes on platelet aggregability.

    Time frame: baseline and 30(+-5) days after drug exposure.

    Primary outcome measure analyzed at baseline and 30(+-5) days after drug exposure.

  2. platelet aggregability differences by two point-of-care methods.

    Time frame: baseline and 4 (+-2) days after drug exposure.

    Comparison on platelet aggregability by two different methods :Verify Now and Multiplate.

  3. platelet aggregability differences by two point-of-care methods.

    Time frame: baseline and 30(+-5) days after drug exposure.

    Comparison on platelet aggregability by two different methods (Verify Now and Multiplate .

Other outcomes

  1. changes in glycemic control(glycemic variability assessed by standard deviation(SD) of capillary glucose samples).

    Time frame: baseline up to 1 week.

    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).

  2. changes in glycemic control(glycemic variability assessed by continuous glucose monitoring system - CGM).

    Time frame: baseline and 48 (+-24) hours after drug exposure.

    Evaluated by mean amplitude of glycemic excursions(MAGE) by the use of CGM

  3. changes on platelet aggregability on pre-specified subgroups.

    Time frame: baseline and 4 (+-2)days after drug exposure.

    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 %

  4. rate of hypoglycemia during coronary care unit stay.

    Time frame: baseline up to 1 week .

    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).

  5. total of insulin doses requirement during coronary care unit stay.

    Time frame: baseline up to 1 week .

    Comparison of the total requirement of correctional insulin between treatment and control arms after drug exposure.

  6. incidence of composite end-point.

    Time frame: baseline and 30 (+-5) days after drug exposure

    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 .

  7. Infarct size.

    Time frame: baseline up to 1 week

    Analysis of infarct size between two arms, by peak of creatine kinase(CK-MB) during CCU stay(expected average of 1 week).

  8. cholesterylester transfer protein(CETP) mass

    Time frame: baseline

    Analysis of CETP mass between two arms.

  9. measure of safety, Number of participants with adverse effects by analysis on changes of serum level

    Time frame: baseline and 30(+-5) days after drug exposure.

    Number of participants with adverse effects by analysis on changes of serum level of :

    alanine transferase;

    brain natriuretic peptide(BNP);

    amylase;

    lipase.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • InCor Heart Institute

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2015
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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