Dapagliflozin Effects on Mayor Adverse Cardiovascular Events in Patients With Acute Myocardial Infarction (DAPA-AMI)

NCT04717986 | Completed DMC

• 1 other identifier: R-2020-1001-155
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Myocardial Infarction; Cardiovascular Morbidity; Heart Failure; Angina, Unstable

Keywords

Acute myocardial infarction; Dapagliflozin; mayor adverse cardiovascular events

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (4)

• Left ventricular ejection fraction

  12 months

• Chronic heart failure

  12 months

• Post infarction angina

  12 months

• Mortality due to cardiovascular cause

  12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Dapagliflozin 10 mg every 24 hours for 12 months

Drug: Dapagliflozin 10Mg Tab

Control Group

PLACEBO COMPARATOR

1 placebo tablet every 24 hours for 12 months

Drug: Placebo

Interventions

Dapagliflozin 10Mg Tab DRUG

patients who meet the inclusion criteria will be randomized to receive dapagliflozin 10 mg every 24 hours for 12 months

Intervention Group

Placebo DRUG

patients meeting the inclusion criteria will be randomized to receive a placebo solution every 24 hours for 12 months

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Unidad Medica de Alta Especialidad No. 1, Bajío

León, Guanajuato, 37260,, Mexico

Location

Related Publications (11)

• 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.

  PMID: 10987628 RESULT

• Thygesen 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.

  PMID: 17951284 RESULT

• Grupo 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.

  PMID: 23040488 RESULT

• Armstrong 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.

  PMID: 23473396 RESULT

• Cantor 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.

  PMID: 19553646 RESULT

• Matheus 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.

  PMID: 23533715 RESULT

• Cowie 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.

  PMID: 32665641 RESULT

• Zinman 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.

  PMID: 26378978 RESULT

• Neal 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.

  PMID: 28605608 RESULT

• Perkovic 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.

  PMID: 30990260 RESULT

• McMurray 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.

  PMID: 31535829 RESULT

MeSH Terms

Conditions

Heart Failure; Angina, Unstable

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Angina Pectoris; Myocardial Ischemia; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hilda E Macias Cervantes, Master in Clinical Research

  Unidad Médica de Alta Especialidad No. 1 Bajío, Boulevard Adolfo López Mateos esquina Insurgentes S/N, colonia Los Paraísos, Leon, Guanajuato, Mexico, 37260

  PRINCIPAL INVESTIGATOR

• German R Bautista Lopez, Cardiology

  Unidad Médica de Alta Especialidad No. 1 Bajío, Boulevard Adolfo López Mateos esquina Insurgentes S/N, colonia Los Paraísos, Leon, Guanajuato, Mexico, 37260

  STUDY DIRECTOR

• Luis J Gonzalez, Cardiology Resident

  Unidad Médica de Alta Especialidad No. 1 Bajío, Boulevard Adolfo López Mateos esquina Insurgentes S/N, colonia Los Paraísos, Leon, Guanajuato, Mexico, 37260

  STUDY CHAIR

• Rodolfo Guardado Mendoza, Endocrinologist

  Unidad de Investigación Metabólica, Universidad de Guanajuato, Boulevard Cañaveral 1001, fracciones de los Aguirre, CP 37672, León, Guanajuato, México

  STUDY DIRECTOR

• Gabriel Fernandez Yañez, Cardiology Resident

  Unidad Médica de Alta Especialidad No. 1 Bajío, Boulevard Adolfo López Mateos esquina Insurgentes S/N, colonia Los Paraísos, Leon, Guanajuato, Mexico, 37260

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internist Physician and Master in Clinical Research assigned to the Internal Medicine Service, High Specialty Medical Unit No. 1, Bajío, Leon, Guanajuato

Model Details: Asses the effect of Dapagliflozin on mayor adverse cardiovascular effects in patients with acute myocardial infarction compared against placebo.

Study Record Dates

• First Submitted: January 17, 2021
• First Posted: January 22, 2021
• Study Start: January 26, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 20, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ME (1)