Platelet Aggregation During Acute Myocardial InfarctionPhase 3NCT02377388
DPP-4 Inhibitors and Acute Myocardial Infarction:Effects on Platelet Function
A Phase 3 study testing sitagliptin OR saxagliptin in people with Platelet Aggregation During Acute Myocardial Infarction, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Aggregation During Acute Myocardial Infarction
- What is being tested?
- sitagliptin OR saxagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Feb 2017to 28 Feb 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute(InCor)-Acute Coronary Care Unit
São Paulo, São Paulo, 01406000
About this study
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.
Read the 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.
- Being tested
- sitagliptin OR saxagliptin, placebo
- Keywords
- diabetes mellitus, platelet function testing, acute coronary syndromes, saxagliptin, sitagliptin, dpp-4 inhibitors
- Medical subject headings
- Diabetes Mellitus, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sitagliptin OR saxagliptinDrug
Also called januvia ® OR onglyza ®
sitagliptin OR saxagliptin tablets, 48(+-24) hours after the beginning of an AMI,and both arms in use of dual anti-platelet therapy (DAPT) .
placeboDrug
Also called PBO
placebo tablets, 48(+-24) hours after the beginning of an AMI,and both arms in use of dual anti-platelet therapy (DAPT) .
| Study group | Role | What they receive |
|---|---|---|
| treatment: DPP4 -i | Active comparator | 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) Receives: Drug: sitagliptin OR saxagliptin |
| control | Placebo comparator | placebo tablets identical to active comparator,administered according to GFR at randomization,during 30 days,OD Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline and 4(+-2) days after drug exposure.
Secondary outcomes (3)
changes on platelet aggregability.
Primary outcome measure analyzed at baseline and 30(+-5) days after drug exposure.
Measured: 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.
Measured: 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 .
Measured: baseline and 30(+-5) days after drug exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study start7 Feb 2017
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for Platelet Aggregation During Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute
- Responsible party
- Sponsor
- Investigators
- Jose C Nicolau, MD,PhD, Principal investigator, Heart Institute(InCor)-University of São Paulo GH-Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377388
- Sponsor's protocol ID
- University of São Paulo GH
- Status last verified
- Feb 2020
- First submitted
- 5 Jan 2015
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kosiborod M, Rathore SS, Inzucchi SE, Masoudi FA, Wang Y, Havranek EP, Krumholz HM. Admission glucose and mortality in elderly patients hospitalized with acute myocardial infarction: implications for patients with and without recognized diabetes. Circulation. 2005 Jun 14;111(23):3078-86. doi: 10.1161/CIRCULATIONAHA.104.517839. Epub 2005 Jun 6.
PubMed 15939812Kosiborod M, Inzucchi SE, Krumholz HM, Xiao L, Jones PG, Fiske S, Masoudi FA, Marso SP, Spertus JA. Glucometrics in patients hospitalized with acute myocardial infarction: defining the optimal outcomes-based measure of risk. Circulation. 2008 Feb 26;117(8):1018-27. doi: 10.1161/CIRCULATIONAHA.107.740498. Epub 2008 Feb 11.
PubMed 18268145Goyal A, Mahaffey KW, Garg J, Nicolau JC, Hochman JS, Weaver WD, Theroux P, Oliveira GB, Todaro TG, Mojcik CF, Armstrong PW, Granger CB. Prognostic significance of the change in glucose level in the first 24 h after acute myocardial infarction: results from the CARDINAL study. Eur Heart J. 2006 Jun;27(11):1289-97. doi: 10.1093/eurheartj/ehi884. Epub 2006 Apr 12.
PubMed 16611669Nicolau JC, Maia LN, Vitola JV, Mahaffey KW, Machado MN, Ramires JA. Baseline glucose and left ventricular remodeling after acute myocardial infarction. J Diabetes Complications. 2007 Sep-Oct;21(5):294-9. doi: 10.1016/j.jdiacomp.2006.01.003.
PubMed 17825753Nicolau JC, Serrano CV Jr, Giraldez RR, Baracioli LM, Moreira HG, Lima F, Franken M, Kalil R, Ramires JA, Giugliano RP. In patients with acute myocardial infarction, the impact of hyperglycemia as a risk factor for mortality is not homogeneous across age-groups. Diabetes Care. 2012 Jan;35(1):150-2. doi: 10.2337/dc11-1170. Epub 2011 Oct 25.
PubMed 22028280Monnier L, Mas E, Ginet C, Michel F, Villon L, Cristol JP, Colette C. Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes. JAMA. 2006 Apr 12;295(14):1681-7. doi: 10.1001/jama.295.14.1681.
PubMed 16609090Esposito K, Nappo F, Marfella R, Giugliano G, Giugliano F, Ciotola M, Quagliaro L, Ceriello A, Giugliano D. Inflammatory cytokine concentrations are acutely increased by hyperglycemia in humans: role of oxidative stress. Circulation. 2002 Oct 15;106(16):2067-72. doi: 10.1161/01.cir.0000034509.14906.ae.
PubMed 12379575Standl E, Schnell O, Ceriello A. Postprandial hyperglycemia and glycemic variability: should we care? Diabetes Care. 2011 May;34 Suppl 2(Suppl 2):S120-7. doi: 10.2337/dc11-s206.
PubMed 21525442Hermanides J, Vriesendorp TM, Bosman RJ, Zandstra DF, Hoekstra JB, Devries JH. Glucose variability is associated with intensive care unit mortality. Crit Care Med. 2010 Mar;38(3):838-42. doi: 10.1097/CCM.0b013e3181cc4be9.
PubMed 20035218Krinsley JS. Glycemic variability: a strong independent predictor of mortality in critically ill patients. Crit Care Med. 2008 Nov;36(11):3008-13. doi: 10.1097/CCM.0b013e31818b38d2.
PubMed 18824908Lipska KJ, Venkitachalam L, Gosch K, Kovatchev B, Van den Berghe G, Meyfroidt G, Jones PG, Inzucchi SE, Spertus JA, DeVries JH, Kosiborod M. Glucose variability and mortality in patients hospitalized with acute myocardial infarction. Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):550-7. doi: 10.1161/CIRCOUTCOMES.111.963298. Epub 2012 Jun 12.
PubMed 22693348Siegelaar SE, Kerr L, Jacober SJ, Devries JH. A decrease in glucose variability does not reduce cardiovascular event rates in type 2 diabetic patients after acute myocardial infarction: a reanalysis of the HEART2D study. Diabetes Care. 2011 Apr;34(4):855-7. doi: 10.2337/dc10-1684.
PubMed 21447661Malmberg K, Ryden L, Efendic S, Herlitz J, Nicol P, Waldenstrom A, Wedel H, Welin L. Randomized trial of insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction (DIGAMI study): effects on mortality at 1 year. J Am Coll Cardiol. 1995 Jul;26(1):57-65. doi: 10.1016/0735-1097(95)00126-k.
PubMed 7797776Malmberg K, Ryden L, Wedel H, Birkeland K, Bootsma A, Dickstein K, Efendic S, Fisher M, Hamsten A, Herlitz J, Hildebrandt P, MacLeod K, Laakso M, Torp-Pedersen C, Waldenstrom A; DIGAMI 2 Investigators. Intense metabolic control by means of insulin in patients with diabetes mellitus and acute myocardial infarction (DIGAMI 2): effects on mortality and morbidity. Eur Heart J. 2005 Apr;26(7):650-61. doi: 10.1093/eurheartj/ehi199. Epub 2005 Feb 23.
PubMed 15728645de Mulder M, Umans VA, Cornel JH, van der Zant FM, Stam F, Oemrawsingh RM, Akkerhuis KM, Boersma E. Intensive glucose regulation in hyperglycemic acute coronary syndrome: results of the randomized BIOMarker study to identify the acute risk of a coronary syndrome-2 (BIOMArCS-2) glucose trial. JAMA Intern Med. 2013 Nov 11;173(20):1896-904. doi: 10.1001/jamainternmed.2013.10074.
PubMed 24018647
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DPP-4 Inhibitors in Patients With Type 2 Diabetes and Acute Myocardial Infarction:Effects on Platelet Function
- ClinicalTrials.gov ID
- NCT02377388
- Acronym / sponsor ID
- University of São Paulo GH
- Keywords
- diabetes mellitus, platelet function testing, acute coronary syndromes, saxagliptin, sitagliptin, dpp-4 inhibitors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- InCor Heart Institute
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment: DPP4 -i | Active comparator | Drug: sitagliptin OR saxagliptinUse 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) |
| control | Placebo comparator | Drug: placeboplacebo tablets identical to active comparator,administered according to GFR at randomization,during 30 days,OD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sitagliptin OR saxagliptinAlso: januvia ® OR onglyza ®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 | treatment: DPP4 -i |
| placeboAlso: PBOplacebo tablets, 48(+-24) hours after the beginning of an AMI,and both arms in use of dual anti-platelet therapy (DAPT) . | Drug | control |
Primary outcome
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).
3 secondary outcomes
changes on platelet aggregability.
Time frame: baseline and 30(+-5) days after drug exposure.
platelet aggregability differences by two point-of-care methods.
Time frame: baseline and 4 (+-2) days after drug exposure.
platelet aggregability differences by two point-of-care methods.
Time frame: baseline and 30(+-5) days after drug exposure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Background: PubMed 15939812Kosiborod M, Rathore SS, Inzucchi SE, Masoudi FA, Wang Y, Havranek EP, Krumholz HM. Admission glucose and mortality in elderly patients hospitalized with acute myocardial infarction: implications for patients with and without recognized diabetes. Circulation. 2005 Jun 14;111(23):3078-86. doi: 10.1161/CIRCULATIONAHA.104.517839. Epub 2005 Jun 6.
- Background: PubMed 18268145Kosiborod M, Inzucchi SE, Krumholz HM, Xiao L, Jones PG, Fiske S, Masoudi FA, Marso SP, Spertus JA. Glucometrics in patients hospitalized with acute myocardial infarction: defining the optimal outcomes-based measure of risk. Circulation. 2008 Feb 26;117(8):1018-27. doi: 10.1161/CIRCULATIONAHA.107.740498. Epub 2008 Feb 11.
- Background: PubMed 16611669Goyal A, Mahaffey KW, Garg J, Nicolau JC, Hochman JS, Weaver WD, Theroux P, Oliveira GB, Todaro TG, Mojcik CF, Armstrong PW, Granger CB. Prognostic significance of the change in glucose level in the first 24 h after acute myocardial infarction: results from the CARDINAL study. Eur Heart J. 2006 Jun;27(11):1289-97. doi: 10.1093/eurheartj/ehi884. Epub 2006 Apr 12.
- Background: PubMed 17825753Nicolau JC, Maia LN, Vitola JV, Mahaffey KW, Machado MN, Ramires JA. Baseline glucose and left ventricular remodeling after acute myocardial infarction. J Diabetes Complications. 2007 Sep-Oct;21(5):294-9. doi: 10.1016/j.jdiacomp.2006.01.003.
- Background: PubMed 22028280Nicolau JC, Serrano CV Jr, Giraldez RR, Baracioli LM, Moreira HG, Lima F, Franken M, Kalil R, Ramires JA, Giugliano RP. In patients with acute myocardial infarction, the impact of hyperglycemia as a risk factor for mortality is not homogeneous across age-groups. Diabetes Care. 2012 Jan;35(1):150-2. doi: 10.2337/dc11-1170. Epub 2011 Oct 25.
- Background: PubMed 16609090Monnier L, Mas E, Ginet C, Michel F, Villon L, Cristol JP, Colette C. Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes. JAMA. 2006 Apr 12;295(14):1681-7. doi: 10.1001/jama.295.14.1681.
- Background: PubMed 12379575Esposito K, Nappo F, Marfella R, Giugliano G, Giugliano F, Ciotola M, Quagliaro L, Ceriello A, Giugliano D. Inflammatory cytokine concentrations are acutely increased by hyperglycemia in humans: role of oxidative stress. Circulation. 2002 Oct 15;106(16):2067-72. doi: 10.1161/01.cir.0000034509.14906.ae.
- Background: PubMed 21525442Standl E, Schnell O, Ceriello A. Postprandial hyperglycemia and glycemic variability: should we care? Diabetes Care. 2011 May;34 Suppl 2(Suppl 2):S120-7. doi: 10.2337/dc11-s206.
- Background: PubMed 20035218Hermanides J, Vriesendorp TM, Bosman RJ, Zandstra DF, Hoekstra JB, Devries JH. Glucose variability is associated with intensive care unit mortality. Crit Care Med. 2010 Mar;38(3):838-42. doi: 10.1097/CCM.0b013e3181cc4be9.
- Background: PubMed 18824908Krinsley JS. Glycemic variability: a strong independent predictor of mortality in critically ill patients. Crit Care Med. 2008 Nov;36(11):3008-13. doi: 10.1097/CCM.0b013e31818b38d2.
- Background: PubMed 22693348Lipska KJ, Venkitachalam L, Gosch K, Kovatchev B, Van den Berghe G, Meyfroidt G, Jones PG, Inzucchi SE, Spertus JA, DeVries JH, Kosiborod M. Glucose variability and mortality in patients hospitalized with acute myocardial infarction. Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):550-7. doi: 10.1161/CIRCOUTCOMES.111.963298. Epub 2012 Jun 12.
- Background: PubMed 21447661Siegelaar SE, Kerr L, Jacober SJ, Devries JH. A decrease in glucose variability does not reduce cardiovascular event rates in type 2 diabetic patients after acute myocardial infarction: a reanalysis of the HEART2D study. Diabetes Care. 2011 Apr;34(4):855-7. doi: 10.2337/dc10-1684.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose C Nicolau, MD,PhD principal investigator
Heart Institute(InCor)-University of São Paulo GH-Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sitagliptin OR saxagliptin in people with Platelet Aggregation During Acute Myocardial Infarction, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes on platelet aggregability. (time frame: baseline and 4(+-2) days after drug exposure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02377388, which also lists 54 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.