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

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

Interventions

DRUG

Dapagliflozin 10Mg Tab

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

DRUG

Placebo

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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social

  lead OTHER_GOV

Principal Investigators

• 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

• 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

• 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

• Rodolfo Guardado Mendoza, Endocrinologist · Unidad de Investigación Metabólica, Universidad de Guanajuato, Boulevard Cañaveral 1001, fracciones de los Aguirre, CP 37672, León, Guanajuato, México

• 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 Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-26

Primary Completion

2022-06-30

Completion

2023-06-20

Countries

• Mexico

Study Locations