DPP-4 Inhibitors and Acute Myocardial Infarction:Effects on Platelet Function
NCT ID: NCT02377388
Last Updated: 2020-08-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
74 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-02-07
Study Completion Date
2020-02-28
Brief Summary
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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.
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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Detailed Description
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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.
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
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Platelet Aggregation During Acute Myocardial Infarction
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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treatment: DPP4 -i
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)
Group Type
ACTIVE_COMPARATOR
sitagliptin OR saxagliptin
Intervention Type
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) .
control
placebo tablets identical to active comparator,administered according to GFR at randomization,during 30 days,OD
Group Type
PLACEBO_COMPARATOR
placebo
Intervention Type
DRUG
placebo tablets, 48(+-24) hours after the beginning of an AMI,and both arms in use of dual anti-platelet therapy (DAPT) .
Interventions
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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) .
Intervention Type
DRUG
placebo
placebo tablets, 48(+-24) hours after the beginning of an AMI,and both arms in use of dual anti-platelet therapy (DAPT) .
Intervention Type
DRUG
Other Intervention Names
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januvia ® OR onglyza ®
PBO
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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InCor Heart Institute
OTHER
Sponsor Role
collaborator
University of Sao Paulo General Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jose C Nicolau, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Heart Institute(InCor)-University of São Paulo GH-Medical School
Locations
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Heart Institute(InCor)-Acute Coronary Care Unit
São Paulo, São Paulo, Brazil
Site Status
Countries
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Brazil
References
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Reference Type
BACKGROUND
McGuire DK, Van de Werf F, Armstrong PW, Standl E, Koglin J, Green JB, Bethel MA, Cornel JH, Lopes RD, Halvorsen S, Ambrosio G, Buse JB, Josse RG, Lachin JM, Pencina MJ, Garg J, Lokhnygina Y, Holman RR, Peterson ED; Trial Evaluating Cardiovascular Outcomes With Sitagliptin (TECOS) Study Group. Association Between Sitagliptin Use and Heart Failure Hospitalization and Related Outcomes in Type 2 Diabetes Mellitus: Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 May 1;1(2):126-35. doi: 10.1001/jamacardio.2016.0103.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
University of São Paulo GH
Identifier Type: -
Identifier Source: org_study_id
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