Rationale and design of the direct oral anticoagulants for prevention of left ventricular thrombus after anterior acute myocardial infarction (APERITIF) trial.
Humans
Platelet Aggregation Inhibitors
/ therapeutic use
ST Elevation Myocardial Infarction
/ therapy
Rivaroxaban
/ therapeutic use
Treatment Outcome
Myocardial Infarction
/ diagnosis
Anterior Wall Myocardial Infarction
Thrombosis
/ etiology
Anticoagulants
/ therapeutic use
Percutaneous Coronary Intervention
/ adverse effects
Journal
American heart journal
ISSN: 1097-6744
Titre abrégé: Am Heart J
Pays: United States
ID NLM: 0370465
Informations de publication
Date de publication:
12 2023
12 2023
Historique:
received:
07
06
2023
revised:
07
09
2023
accepted:
09
09
2023
medline:
20
11
2023
pubmed:
17
9
2023
entrez:
16
9
2023
Statut:
ppublish
Résumé
Anterior acute myocardial infarction (AMI) is associated with an increased risk of left ventricular (LV) thrombus formation. We hypothesized that adding low-dose oral rivaroxaban to the usual antiplatelet regimen would reduce the risk of LV thrombus in patients with large AMI. APERITIF is an investigator-initiated, multicenter randomized open-label, blinded end-point (PROBE) trial, nested in the ongoing "FRENCHIE" registry, a French multicenter prospective observational study, in which all consecutive patients admitted within 48 hours of symptom onset in a cardiac Intensive Care Unit (ICU) for AMI are included (NCT04050956). Among them, patients with anterior ST-elevation-myocardial infarction (STEMI) or very high-risk non- ST-elevation-myocardial infarction (NSTEMI) patients with involvement of the left anterior descending artery are randomized into 2 groups: Dual Antiplatelet Therapy (DAPT) alone or DAPT plus rivaroxaban 2.5mg twice daily for 4 weeks, started as soon as possible after completion of the initial percutaneous coronary intervention/angiography procedure. The primary endpoint is the presence of LV thrombus at 1 month, as detected by contrast enhanced CMR (CE-CMR). Secondary endpoints include LV thrombus dimension (greatest diameter), the rate of major bleedings and major cardiovascular events at 1 month. Based on estimated event rates, a sample size of 560 patients is needed to show superiority of DAPT plus rivaroxaban therapy versus DAPT alone, with 80% power. The APERITIF trial will determine whether, in patients with large AMIs, the use of rivaroxaban 2.5mg twice daily in addition to DAPT reduces LV thrombus formation, compared with DAPT alone. gov Identifier: NCT05077683.
Sections du résumé
BACKGROUND
Anterior acute myocardial infarction (AMI) is associated with an increased risk of left ventricular (LV) thrombus formation. We hypothesized that adding low-dose oral rivaroxaban to the usual antiplatelet regimen would reduce the risk of LV thrombus in patients with large AMI.
STUDY DESIGN
APERITIF is an investigator-initiated, multicenter randomized open-label, blinded end-point (PROBE) trial, nested in the ongoing "FRENCHIE" registry, a French multicenter prospective observational study, in which all consecutive patients admitted within 48 hours of symptom onset in a cardiac Intensive Care Unit (ICU) for AMI are included (NCT04050956). Among them, patients with anterior ST-elevation-myocardial infarction (STEMI) or very high-risk non- ST-elevation-myocardial infarction (NSTEMI) patients with involvement of the left anterior descending artery are randomized into 2 groups: Dual Antiplatelet Therapy (DAPT) alone or DAPT plus rivaroxaban 2.5mg twice daily for 4 weeks, started as soon as possible after completion of the initial percutaneous coronary intervention/angiography procedure. The primary endpoint is the presence of LV thrombus at 1 month, as detected by contrast enhanced CMR (CE-CMR). Secondary endpoints include LV thrombus dimension (greatest diameter), the rate of major bleedings and major cardiovascular events at 1 month. Based on estimated event rates, a sample size of 560 patients is needed to show superiority of DAPT plus rivaroxaban therapy versus DAPT alone, with 80% power.
CONCLUSION
The APERITIF trial will determine whether, in patients with large AMIs, the use of rivaroxaban 2.5mg twice daily in addition to DAPT reduces LV thrombus formation, compared with DAPT alone.
CLINICALTRIALS
gov Identifier: NCT05077683.
Identifiants
pubmed: 37716448
pii: S0002-8703(23)00278-8
doi: 10.1016/j.ahj.2023.09.005
pii:
doi:
Substances chimiques
Platelet Aggregation Inhibitors
0
Rivaroxaban
9NDF7JZ4M3
Anticoagulants
0
Banques de données
ClinicalTrials.gov
['NCT05077683']
Types de publication
Randomized Controlled Trial
Multicenter Study
Observational Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
98-105Informations de copyright
Copyright © 2023 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Disclosures EP has received fees for lectures and/or consulting: Amgen, Astra-Zeneca, BMS, Bayer, Boehringer Ingelheim, Daiichi-Sankyo, Lilly, MSD, Novartis, Pfizer, The Medicine Company, Sanofi, Saint Jude Medical, Servier, Siemens. BAYER is a sponsor of the trial.