NCT04300582: FARADMI

Fast Radial Pharmaco-invasive Strategy In ST Elevation Myocardial Infarction Trial

Status unknown NA Last updated 31 March 2020

What this trial tests

NA trial testing Cardiac catheterization standard strategy in ST-segment Elevation Myocardial Infarction (STEMI) in 120 participants. Status unknown.

Timeline

13 December 2019

Primary endpoint
31 July 2021

31 August 2021

Quick facts

Lead sponsor	University of Sao Paulo General Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	13 December 2019
Primary completion	31 July 2021
Estimated completion	31 August 2021
Sites	1 location across Brazil

Drugs / interventions tested

• Cardiac catheterization standard strategy
• Cardiac catheterization fast strategy

Conditions studied

• ST-segment Elevation Myocardial Infarction (STEMI) — all drugs for ST-segment Elevation Myocardial Infarction (STEMI) →

Sponsor

University of Sao Paulo General Hospital

Who can join

Adults 18 to 80, any sex, with ST-segment Elevation Myocardial Infarction (STEMI). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

INTRODUCTION: The pharmaco-invasive strategy is a safe alternative to primary percutaneous coronary intervention (PCI) in patients with ST elevation acute myocardial infarction, who cannot be in the cathlab in less than 120 minutes. However, previous studies of this strategy used the femoral artery as the main vascular access. Current studies show that the use of the radial artery in cases of acute myocardial infarction minimizes the risk of bleeding and mortality. Therefore, in the scenario where vascular access through the forearm vessels is recommended, the best timing to perform cardiac catheterization in the pharmaco-invasive strategy is not known.

OBJECTIVE: To compare the 24-hour hemoglobin drop (acute anemia) between the fast pharmaco-invasive strategy (within 3 hours) and the standard pharmaco-invasive strategy (3 to 24 hours) in patients with acute myocardial infarction (AMI) by coronary occlusion treated in Sancta Maggiore hospitals in São Paulo and underwent to cardiac catheterization through the forearm vessels.

METHOD: A prospective, randomized, multicenter study will be conducted in which 120 subjects will be randomly divided for fast and standard cardiac catheterization (1: 1). Stent implantation in the culprit vessel will be performed. The primary objective is to assess whether the fast cardiac catheterization is non-inferior to the standard strategy for a hemoglobin (Hb) drop within 24 hours. Considering in the control group an average drop of Hb 0.6 ± 1g / dl and that a drop greater than 3 g/dL of Hb is related to unfavorable clinical outcome, using a two-tailed alpha of 0.05 and a power of 90% to test the non-inferiority of the fast strategy with respect to standard strategy, each group will require 60 patients, totaling 120 individuals to include. However, if Hb fall in the fast strategy is greater than 3 g/dL and this result does not reproduce in the standard strategy, the study will allow us to show the superiority of the standard approach (between 3 and 24 hours).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.