Acute Myocardial InfarctionDAPA-AMINCT04717986
Dapagliflozin Effects on Mayor Adverse Cardiovascular Events in Patients With Acute Myocardial Infarction (DAPA-AMI)
A study testing Dapagliflozin 10Mg Tab in people with Acute Myocardial Infarction and Cardiovascular Morbidity, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
The actual evidence is solid about the use of de SGLT2-inhibitors in wide spectrum of cardiorenal targets, which has been shown in a great amount of randomized clinical trials compared with placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myocardial Infarction, Cardiovascular Morbidity, Heart Failure
- What is being tested?
- Dapagliflozin 10Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteMexico
- Study dates
- 26 Jan 2021to 20 Jun 2023
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female IMSS eligible patients over 18 years of age
- Meet the criteria of the fourth definition of ST-segment elevation myocardial infarction
- Known with diabetes mellitus 2 or newly diagnosed diabetes according to ADA criteria
Who cannot join
- Patients diagnosed with Type 1 Diabetes Mellitus
- Patients on chronic replacement therapy for renal function through peritoneal dialysis or hemodialysis
- Patients who have recently undergone immunosuppressive therapy
- Patients with a history of recurrent urinary tract infection
- Patients known to be allergic to SGLT-2 inhibitors
- Patients presenting as sudden aborted death
- Patients who after percutaneous coronary intervention require orotracheal intubation
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unidad Medica de Alta Especialidad No. 1, Bajío
León, Guanajuato, 37260,
About this study
Official title: Dapagliflozin Effects on Mayor Adverse Cardiovascular Events in Patients With Acute Myocardial Infarction (DAPA-AMI). Randomized Clinical Trial
The actual evidence is solid about the use of de SGLT2-inhibitors in wide spectrum of cardiorenal targets, which has been shown in a great amount of randomized clinical trials compared with placebo. At present it must be taken into account as first line treatment in patients with DM2, even their security profile has allowed the use in patients without diagnosis of DM2, since they have be shown a beneficial cardioprotect effects. Most studies support they use in patients with high cardiovascular risk, nevertheless, their use in patients with recent diagnosis of ischemic hearth disease its limited, being the latter entity the most frequent etiology found in patients who develop chronic hearth failure either as part of heart attack or unstable angina.
Read the detailed description
According with the World Health Organization, cardiovascular disease is the leading cause of mortality in the world, estimating 17.9 millions of deaths a year. The cardiovascular disease are a group of disorders of the hearth and the blood vessels including coronary artery disease, cerebrovascular disease, rheumatic hearth disease and other conditions. Four out of five deaths attributed to cardiovascular cause are related to acute myocardial infarction and cerebrovascular disease and one third of this deaths occur in persons younger than 70 years.
The concept of acute coronary syndrome includes the ST elevation myocardial infarction who presents a ST elevation in two contiguous leads or complete left branch bundle block instead patients who presents without ST elevation in the electrocardiogram they are usually classified as Non ST elevation acute myocardial infarction.
The optimum treatment of the STEMI must be based in the utilization of networks between hospitals with different technology levels connected by an efficient y prioritized ambulance system. The objective of this networks is to provide an efficient medical attention, reduce the lag time and to get better the clinical results. The percutaneous coronary intervention is the preferred treatment of reperfusion for the patients with acute myocardial infarction on the first 12 hours after the development of symptoms, provided it can be done quickly (120 minutes since the diagnosis). In some circumstances, the PCI is not an option, then the fibrinolysis could be started immediately.
Most patients with ischemic heart disease are carriers of DM2. The DM2 is associated to an increase 3 times the risk of cardiovascular disease being this the principal cause of morbidity and mortality in this patients. Further, more than 40% of the patient with DM2 develops diabetic nephropathy and this increase strongly the risk of poor cardiovascular outcomes.
Improve the glycemic control in patients with DM2 has been a major objective in the clinical practice for decades, abreast to a reduction of the multifactorial cardiovascular risk. On randomized trials, controlled with placebo, the sodium-glucose linked transported inhibitors type 2 have shown convincingly improve the cardiovascular results, including a reduction in cardiovascular death and particularly, the reduction in the occurrence of heart failure leading to hospitalization . The consistent evidence of the beneficial cardiovascular effects of SGLT-2 inhibitors has led to recommend it in international papers for patients with DM2 and cardiovascular disease in addition to metformin, regardless of their basal levels of glycated hemoglobin.
The clinical trial EMPAREG OUTCOME in patients with DM2 and cardiovascular disease who receive a standard medical treatment shown a reduce in risk of MACE with empagliflozin compared with placebo, conferred mainly by a reduction in cardiovascular death. Mortality from all causes fell as well the risk of hospitalization associated to hearth failure. The CANVAS PROGRAM in patients with DM2 and high cardiovascular risk (66% had cardiovascular disease) shown also a reduction of risk of MACE with the use of canagiflozin compared against placebo, though the reduction on the risk of cardiovascular death and mortality by all causes didn't reach statistical significance.
The clinical trial DAPAHF included patients with LVEF of 45% and DM2 diagnosis. During the follow up (18.2 months) the patients aleatory assigned to receive dapagliflozin (in addition to standard medical therapy) had a significant reduction of 26% in risk of death from cardiovascular cause or deterioration of heart failure compared with placebo group, with a reduction of 18% of cardiovascular death. The amount of the effect were similar between patients with or without DM2, indicating a new beneficial mechanism that goes beyond glycemic control.
The SGLT-2 inhibitors effectively increase glycosuria, improve glycemic control and reduce the corporal mass index due to calorie loss. In addition, promote sodium excretion trough urine early (with a reduction in the plasmatic volume and increase in hematocrit), reduce the systemic blood pressure, and reduce the glomerular hyperfiltation and albuminuria. It is uncertain which of this mechanisms underlies the cardiovascular and renal benefits that had been shown in the big clinical trials but probably the sodium excretion trough urine early followed by a change in tisular sodium give a back up to protect against the decompensation against heart failure and the studies support this includes in patients without diagnosis of DM2. Other beneficial mechanisms includes a reduction in the inflammation mediated by adipose tissue and production of pro inflammatory cytokines, reduction in oxidative stress, inhibition of the exchanger Na+ / H+ of the myocardium and reduced levels of serum uric acid.
- Being tested
- Dapagliflozin 10Mg Tab, Placebo
- Keywords
- Acute myocardial infarction, Dapagliflozin, mayor adverse cardiovascular events
- Medical subject headings
- Heart Failure, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10Mg TabDrug
patients who meet the inclusion criteria will be randomized to receive dapagliflozin 10 mg every 24 hours for 12 months
PlaceboDrug
patients meeting the inclusion criteria will be randomized to receive a placebo solution every 24 hours for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Dapagliflozin 10 mg every 24 hours for 12 months Receives: Drug: Dapagliflozin 10Mg Tab |
| Control Group | Placebo comparator | 1 placebo tablet every 24 hours for 12 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mayor adverse cardiovascular effects
To assess the presence of myocardial infarction, stroke and death from cardiovascular causes in post-infarction patients during the study follow-up
Measured: 12 months
Secondary outcomes (4)
Left ventricular ejection fraction
Evaluate baseline left ventricular ejection fraction in post-infarct patients and 12 months of treatment
Measured: 12 months
Chronic heart failure
Evaluate the effect of Dapagliflozin on the development of chronic heart failure that deserves hospitalization
Measured: 12 months
Post infarction angina
Evaluate the effect of Dapagliflozin on the development of post infarction angina
Measured: 12 months
Mortality due to cardiovascular cause
Assess the presence of mortality due to cardiovascular causes during the study follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start26 Jan 2021
- Primary completion30 Jun 2022
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Asses the effect of Dapagliflozin on mayor adverse cardiovascular effects in patients with acute myocardial infarction compared against placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hilda Elizabeth Macías Cervantes, Instituto Mexicano del Seguro Social
- Investigators
- Hilda E Macias Cervantes, Master in Clinical Research, Principal investigator, Unidad Médica de Alta Especialidad No. 1 Bajío, Boulevard Adolfo López Mateos esquina Insurgentes S/N, colonia Los Paraísos, Leon, Guanajuato, Mexico, 37260German R Bautista Lopez, Cardiology, Study director, Unidad Médica de Alta Especialidad No. 1 Bajío, Boulevard Adolfo López Mateos esquina Insurgentes S/N, colonia Los Paraísos, Leon, Guanajuato, Mexico, 37260Luis J Gonzalez, Cardiology Resident, Study chair, Unidad Médica de Alta Especialidad No. 1 Bajío, Boulevard Adolfo López Mateos esquina Insurgentes S/N, colonia Los Paraísos, Leon, Guanajuato, Mexico, 37260Rodolfo Guardado Mendoza, Endocrinologist, Study director, Unidad de Investigación Metabólica, Universidad de Guanajuato, Boulevard Cañaveral 1001, fracciones de los Aguirre, CP 37672, León, Guanajuato, MéxicoGabriel Fernandez Yañez, Cardiology Resident, Study chair, Unidad Médica de Alta Especialidad No. 1 Bajío, Boulevard Adolfo López Mateos esquina Insurgentes S/N, colonia Los Paraísos, Leon, Guanajuato, Mexico, 37260
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717986
- Sponsor's protocol ID
- R-2020-1001-155
- Acronym
- DAPA-AMI
- Status last verified
- Jun 2023
- First submitted
- 17 Jan 2021
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Alpert JS, Thygesen K, Antman E, Bassand JP. Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol. 2000 Sep;36(3):959-69. doi: 10.1016/s0735-1097(00)00804-4.
PubMed 10987628Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction; Jaffe AS, Apple FS, Galvani M, Katus HA, Newby LK, Ravkilde J, Chaitman B, Clemmensen PM, Dellborg M, Hod H, Porela P, Underwood R, Bax JJ, Beller GA, Bonow R, Van der Wall EE, Bassand JP, Wijns W, Ferguson TB, Steg PG, Uretsky BF, Williams DO, Armstrong PW, Antman EM, Fox KA, Hamm CW, Ohman EM, Simoons ML, Poole-Wilson PA, Gurfinkel EP, Lopez-Sendon JL, Pais P, Mendis S, Zhu JR, Wallentin LC, Fernandez-Aviles F, Fox KM, Parkhomenko AN, Priori SG, Tendera M, Voipio-Pulkki LM, Vahanian A, Camm AJ, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Morais J, Brener S, Harrington R, Morrow D, Lim M, Martinez-Rios MA, Steinhubl S, Levine GN, Gibler WB, Goff D, Tubaro M, Dudek D, Al-Attar N. Universal definition of myocardial infarction. Circulation. 2007 Nov 27;116(22):2634-53. doi: 10.1161/CIRCULATIONAHA.107.187397. Epub 2007 Oct 19. No abstract available.
PubMed 17951284Grupo de Trabajo de la Sociedad Europea de Cardiologia (ESC) sobre el manejo del infarto agudo de miocardio con elevacion del segmento ST (IAMCEST). Rev Esp Cardiol. 2009 Mar;62(3):293.e1-293.e47. doi: 10.1016/S0300-8932(09)70373-2. Epub 2009 Mar 19. No abstract available. English, Spanish.
PubMed 23040488Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Danays T, Lambert Y, Sulimov V, Rosell Ortiz F, Ostojic M, Welsh RC, Carvalho AC, Nanas J, Arntz HR, Halvorsen S, Huber K, Grajek S, Fresco C, Bluhmki E, Regelin A, Vandenberghe K, Bogaerts K, Van de Werf F; STREAM Investigative Team. Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction. N Engl J Med. 2013 Apr 11;368(15):1379-87. doi: 10.1056/NEJMoa1301092. Epub 2013 Mar 10.
PubMed 23473396Cantor WJ, Fitchett D, Borgundvaag B, Ducas J, Heffernan M, Cohen EA, Morrison LJ, Langer A, Dzavik V, Mehta SR, Lazzam C, Schwartz B, Casanova A, Goodman SG; TRANSFER-AMI Trial Investigators. Routine early angioplasty after fibrinolysis for acute myocardial infarction. N Engl J Med. 2009 Jun 25;360(26):2705-18. doi: 10.1056/NEJMoa0808276.
PubMed 19553646Matheus AS, Tannus LR, Cobas RA, Palma CC, Negrato CA, Gomes MB. Impact of diabetes on cardiovascular disease: an update. Int J Hypertens. 2013;2013:653789. doi: 10.1155/2013/653789. Epub 2013 Mar 4.
PubMed 23533715Cowie MR, Fisher M. SGLT2 inhibitors: mechanisms of cardiovascular benefit beyond glycaemic control. Nat Rev Cardiol. 2020 Dec;17(12):761-772. doi: 10.1038/s41569-020-0406-8. Epub 2020 Jul 14.
PubMed 32665641Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
PubMed 26378978Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Aug 17;377(7):644-657. doi: 10.1056/NEJMoa1611925. Epub 2017 Jun 12.
PubMed 28605608Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14.
PubMed 30990260McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
PubMed 31535829Macias-Cervantes HE, Guardado-Mendoza R, Gonzalez LJ, Bautista-Lopez GR, Hernandez-Tizapa K, Carrillo-Torres MA, Fernandez-Yanez G, Hinojosa-Gutierrez LR, Bernal-Ruiz EA, Cardenas-Munoz ME, Nava-Cabrera JI, Caporal-Trejo LC, Emigdio-Loeza A, Hernandez-Gonzalez MA, Macias-Cervantes MH. Dapagliflozin in acute myocardial infarction with type 2 diabetes: a randomized clinical trial. Curr Probl Cardiol. 2026 Oct;51(10):103401. doi: 10.1016/j.cpcardiol.2026.103401. Epub 2026 Jul 18.
PubMed 42471097
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dapagliflozin Effects on Mayor Adverse Cardiovascular Events in Patients With Acute Myocardial Infarction (DAPA-AMI). Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04717986
- Acronym / sponsor ID
- DAPA-AMI / R-2020-1001-155
- Keywords
- Acute myocardial infarction, Dapagliflozin, mayor adverse cardiovascular events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 22 Jan 2021 (actual)
- 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.
The actual evidence is solid about the use of de SGLT2-inhibitors in wide spectrum of cardiorenal targets, which has been shown in a great amount of randomized clinical trials compared with placebo. At present it must be taken into account as first line treatment in patients with DM2, even their security profile has allowed the use in patients without diagnosis of DM2, since they have be shown a beneficial cardioprotect effects. Most studies support they use in patients with high cardiovascular risk, nevertheless, their use in patients with recent diagnosis of ischemic hearth disease its limited, being the latter entity the most frequent etiology found in patients who develop chronic hearth failure either as part of heart attack or unstable angina.
Detailed description
According with the World Health Organization, cardiovascular disease is the leading cause of mortality in the world, estimating 17.9 millions of deaths a year. The cardiovascular disease are a group of disorders of the hearth and the blood vessels including coronary artery disease, cerebrovascular disease, rheumatic hearth disease and other conditions. Four out of five deaths attributed to cardiovascular cause are related to acute myocardial infarction and cerebrovascular disease and one third of this deaths occur in persons younger than 70 years.
The concept of acute coronary syndrome includes the ST elevation myocardial infarction who presents a ST elevation in two contiguous leads or complete left branch bundle block instead patients who presents without ST elevation in the electrocardiogram they are usually classified as Non ST elevation acute myocardial infarction.
The optimum treatment of the STEMI must be based in the utilization of networks between hospitals with different technology levels connected by an efficient y prioritized ambulance system. The objective of this networks is to provide an efficient medical attention, reduce the lag time and to get better the clinical results. The percutaneous coronary intervention is the preferred treatment of reperfusion for the patients with acute myocardial infarction on the first 12 hours after the development of symptoms, provided it can be done quickly (120 minutes since the diagnosis). In some circumstances, the PCI is not an option, then the fibrinolysis could be started immediately.
Most patients with ischemic heart disease are carriers of DM2. The DM2 is associated to an increase 3 times the risk of cardiovascular disease being this the principal cause of morbidity and mortality in this patients. Further, more than 40% of the patient with DM2 develops diabetic nephropathy and this increase strongly the risk of poor cardiovascular outcomes.
Improve the glycemic control in patients with DM2 has been a major objective in the clinical practice for decades, abreast to a reduction of the multifactorial cardiovascular risk. On randomized trials, controlled with placebo, the sodium-glucose linked transported inhibitors type 2 have shown convincingly improve the cardiovascular results, including a reduction in cardiovascular death and particularly, the reduction in the occurrence of heart failure leading to hospitalization . The consistent evidence of the beneficial cardiovascular effects of SGLT-2 inhibitors has led to recommend it in international papers for patients with DM2 and cardiovascular disease in addition to metformin, regardless of their basal levels of glycated hemoglobin.
The clinical trial EMPAREG OUTCOME in patients with DM2 and cardiovascular disease who receive a standard medical treatment shown a reduce in risk of MACE with empagliflozin compared with placebo, conferred mainly by a reduction in cardiovascular death. Mortality from all causes fell as well the risk of hospitalization associated to hearth failure. The CANVAS PROGRAM in patients with DM2 and high cardiovascular risk (66% had cardiovascular disease) shown also a reduction of risk of MACE with the use of canagiflozin compared against placebo, though the reduction on the risk of cardiovascular death and mortality by all causes didn't reach statistical significance.
The clinical trial DAPAHF included patients with LVEF of 45% and DM2 diagnosis. During the follow up (18.2 months) the patients aleatory assigned to receive dapagliflozin (in addition to standard medical therapy) had a significant reduction of 26% in risk of death from cardiovascular cause or deterioration of heart failure compared with placebo group, with a reduction of 18% of cardiovascular death. The amount of the effect were similar between patients with or without DM2, indicating a new beneficial mechanism that goes beyond glycemic control.
The SGLT-2 inhibitors effectively increase glycosuria, improve glycemic control and reduce the corporal mass index due to calorie loss. In addition, promote sodium excretion trough urine early (with a reduction in the plasmatic volume and increase in hematocrit), reduce the systemic blood pressure, and reduce the glomerular hyperfiltation and albuminuria. It is uncertain which of this mechanisms underlies the cardiovascular and renal benefits that had been shown in the big clinical trials but probably the sodium excretion trough urine early followed by a change in tisular sodium give a back up to protect against the decompensation against heart failure and the studies support this includes in patients without diagnosis of DM2. Other beneficial mechanisms includes a reduction in the inflammation mediated by adipose tissue and production of pro inflammatory cytokines, reduction in oxidative stress, inhibition of the exchanger Na+ / H+ of the myocardium and reduced levels of serum uric acid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Asses the effect of Dapagliflozin on mayor adverse cardiovascular effects in patients with acute myocardial infarction compared against placebo.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Dapagliflozin 10Mg TabDapagliflozin 10 mg every 24 hours for 12 months |
| Control Group | Placebo comparator | Drug: Placebo1 placebo tablet every 24 hours for 12 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female IMSS eligible patients over 18 years of age
- Meet the criteria of the fourth definition of ST-segment elevation myocardial infarction
- Known with diabetes mellitus 2 or newly diagnosed diabetes according to ADA criteria
Key exclusion criteria (7 listed)
- Patients diagnosed with Type 1 Diabetes Mellitus
- Patients on chronic replacement therapy for renal function through peritoneal dialysis or hemodialysis
- Patients who have recently undergone immunosuppressive therapy
- Patients with a history of recurrent urinary tract infection
- Patients known to be allergic to SGLT-2 inhibitors
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 |
|---|---|---|
| Dapagliflozin 10Mg Tabpatients who meet the inclusion criteria will be randomized to receive dapagliflozin 10 mg every 24 hours for 12 months | Drug | Intervention Group |
| Placebopatients meeting the inclusion criteria will be randomized to receive a placebo solution every 24 hours for 12 months | Drug | Control Group |
Primary outcome
Mayor adverse cardiovascular effects
Time frame: 12 months
To assess the presence of myocardial infarction, stroke and death from cardiovascular causes in post-infarction patients during the study follow-up
4 secondary outcomes
Left ventricular ejection fraction
Time frame: 12 months
Chronic heart failure
Time frame: 12 months
Post infarction angina
Time frame: 12 months
Mortality due to cardiovascular cause
Time frame: 12 months
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 26 Jun 2023.
- Results publication: PubMed 10987628Alpert JS, Thygesen K, Antman E, Bassand JP. Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol. 2000 Sep;36(3):959-69. doi: 10.1016/s0735-1097(00)00804-4.
- Results publication: PubMed 17951284Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction; Jaffe AS, Apple FS, Galvani M, Katus HA, Newby LK, Ravkilde J, Chaitman B, Clemmensen PM, Dellborg M, Hod H, Porela P, Underwood R, Bax JJ, Beller GA, Bonow R, Van der Wall EE, Bassand JP, Wijns W, Ferguson TB, Steg PG, Uretsky BF, Williams DO, Armstrong PW, Antman EM, Fox KA, Hamm CW, Ohman EM, Simoons ML, Poole-Wilson PA, Gurfinkel EP, Lopez-Sendon JL, Pais P, Mendis S, Zhu JR, Wallentin LC, Fernandez-Aviles F, Fox KM, Parkhomenko AN, Priori SG, Tendera M, Voipio-Pulkki LM, Vahanian A, Camm AJ, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Morais J, Brener S, Harrington R, Morrow D, Lim M, Martinez-Rios MA, Steinhubl S, Levine GN, Gibler WB, Goff D, Tubaro M, Dudek D, Al-Attar N. Universal definition of myocardial infarction. Circulation. 2007 Nov 27;116(22):2634-53. doi: 10.1161/CIRCULATIONAHA.107.187397. Epub 2007 Oct 19. No abstract available.
- Results publication: PubMed 23040488Grupo de Trabajo de la Sociedad Europea de Cardiologia (ESC) sobre el manejo del infarto agudo de miocardio con elevacion del segmento ST (IAMCEST). Rev Esp Cardiol. 2009 Mar;62(3):293.e1-293.e47. doi: 10.1016/S0300-8932(09)70373-2. Epub 2009 Mar 19. No abstract available. English, Spanish.
- Results publication: PubMed 23473396Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Danays T, Lambert Y, Sulimov V, Rosell Ortiz F, Ostojic M, Welsh RC, Carvalho AC, Nanas J, Arntz HR, Halvorsen S, Huber K, Grajek S, Fresco C, Bluhmki E, Regelin A, Vandenberghe K, Bogaerts K, Van de Werf F; STREAM Investigative Team. Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction. N Engl J Med. 2013 Apr 11;368(15):1379-87. doi: 10.1056/NEJMoa1301092. Epub 2013 Mar 10.
- Results publication: PubMed 19553646Cantor WJ, Fitchett D, Borgundvaag B, Ducas J, Heffernan M, Cohen EA, Morrison LJ, Langer A, Dzavik V, Mehta SR, Lazzam C, Schwartz B, Casanova A, Goodman SG; TRANSFER-AMI Trial Investigators. Routine early angioplasty after fibrinolysis for acute myocardial infarction. N Engl J Med. 2009 Jun 25;360(26):2705-18. doi: 10.1056/NEJMoa0808276.
- Results publication: PubMed 23533715Matheus AS, Tannus LR, Cobas RA, Palma CC, Negrato CA, Gomes MB. Impact of diabetes on cardiovascular disease: an update. Int J Hypertens. 2013;2013:653789. doi: 10.1155/2013/653789. Epub 2013 Mar 4.
- Results publication: PubMed 32665641Cowie MR, Fisher M. SGLT2 inhibitors: mechanisms of cardiovascular benefit beyond glycaemic control. Nat Rev Cardiol. 2020 Dec;17(12):761-772. doi: 10.1038/s41569-020-0406-8. Epub 2020 Jul 14.
- Results publication: PubMed 26378978Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
- Results publication: PubMed 28605608Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Aug 17;377(7):644-657. doi: 10.1056/NEJMoa1611925. Epub 2017 Jun 12.
- Results publication: PubMed 30990260Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14.
- Results publication: PubMed 31535829McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
- Derived from this study: PubMed 42471097Macias-Cervantes HE, Guardado-Mendoza R, Gonzalez LJ, Bautista-Lopez GR, Hernandez-Tizapa K, Carrillo-Torres MA, Fernandez-Yanez G, Hinojosa-Gutierrez LR, Bernal-Ruiz EA, Cardenas-Munoz ME, Nava-Cabrera JI, Caporal-Trejo LC, Emigdio-Loeza A, Hernandez-Gonzalez MA, Macias-Cervantes MH. Dapagliflozin in acute myocardial infarction with type 2 diabetes: a randomized clinical trial. Curr Probl Cardiol. 2026 Oct;51(10):103401. doi: 10.1016/j.cpcardiol.2026.103401. Epub 2026 Jul 18.
- Individual participant dataSharing planned: Yes
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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.
Hilda E Macias Cervantes, Master in Clinical Research principal investigator
Unidad Médica de Alta Especialidad No. 1 Bajío, Boulevard Adolfo López Mateos esquina Insurgentes S/N, colonia Los Paraísos, Leon, Guanajuato, Mexico, 37260
German R Bautista Lopez, Cardiology study director
Unidad Médica de Alta Especialidad No. 1 Bajío, Boulevard Adolfo López Mateos esquina Insurgentes S/N, colonia Los Paraísos, Leon, Guanajuato, Mexico, 37260
Luis J Gonzalez, Cardiology Resident study chair
Unidad Médica de Alta Especialidad No. 1 Bajío, Boulevard Adolfo López Mateos esquina Insurgentes S/N, colonia Los Paraísos, Leon, Guanajuato, Mexico, 37260
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dapagliflozin 10Mg Tab in people with Acute Myocardial Infarction and Cardiovascular Morbidity, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 3 inclusion and 7 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 26 Jun 2023. 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 Mexico. 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.
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?
Mayor adverse cardiovascular effects (time frame: 12 months). 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 NCT04717986, which also lists 12 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 26 Jun 2023.