MedTrace Logo

Short and Intermediate Term Effect of Dapagliflozin on Left Ventricular Remodeling in Anterior STEMI Patients

NCT05957887 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-04-16

No results posted yet for this study

Summary

Methodology This study will enroll (120) patients presenting with acute anterior STEMI who will undergo early reperfusion presenting at Helwan University Hospitals and Ain Shams University Hospitals.

Diagnosis of STEMI will be based on:

Sustained ST-segment elevation of at least 1 mm in at least 2 contiguous leads or new/presumably new left bundle branch block, plus \>Typical anginal pain, or \> diagnostic levels of serum cardiac biomarkers, or \> imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

They will be subdivided into two (2) groups according to Dapagliflozin intake into:

\- Group A:

Patients with diabetes mellitus (DM) (60) patients, they will be further subdivided into 2 subgroups:

Group A1:

30 patients will receive Dapagliflozin in addition to standard anti-ischemic and anti-diabetic treatment.

Group A2:

30 patients will receive standard anti-ischemic and antidiabetic treatment (Dapagliflozin not included).

\- Group B:

Patients without DM (60) patients, subdivided to 2 subgroups:

Group B1:

30 patients will receive standard anti-ischemic treatment.

Group B2:

30 patients will receiv up e standard anti-ischemic treatment and Dapagliflozin.

Methodology in details:

The study patients will undergo early reperfusion according to the recent practice guidelines and the local hospital policy in managing ST elevation MI patients. Echocardiography will be performed twice: within 48 hours of admission and 3 months following the index event.

Management:

Twelve-lead electrocardiogram will be recorded at baseline and 30-min post-procedure. The ST-segment changes will be evaluated in the single lead with the most prominent ST-segment elevation before intervention. The ST-segment elevation will be measured to the nearest 0.5 mm at 60 ms after the J point. Significant ST segment resolution (STR) is defined as a reduction in ST-segment elevation of 50% after 30 min of infarct artery recanalization.

Immediately before the procedure, patients will receive aspirin (300 mg), ticagrelor (180 mg) or clopidogrel (600 mg) depending on availability. Adjunctive pharmacological treatment during the procedure will include:

1. Unfractionated heparin as an initial bolus of 70 U/kg and additional boluses during the procedure to achieve an activated clotting time of 250 to 350 s (200 to 250 s if Glycoprotein IIb/IIIa (GPIIb/IIIa) antagonist is used). Heparin will be discontinued at the end of percutaneous coronary intervention.
2. The use of a GPIIb/IIIa antagonist during the procedure, primary PCI technique, indications, and methods of thrombectomy if indicated will be done under the regulations of the local hospital policy and the most recent practice guidelines.

Conditions

  • STEMI

Interventions

DRUG

Dapagliflozin

Assess the efficacy of Dapagliflozin on cardiac function and LV remodeling in acute ST elevation anterior myocardial infarction patients

Sponsors & Collaborators

  • Mohamed Nabil Elkholy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-15
Primary Completion
2025-03-15
Completion
2025-04-15
FDA Drug
Yes

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05957887 on ClinicalTrials.gov