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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001534-19 | EudraCT Number |
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APERITIF is a prospective randomized open-label, blinded end-point (PROBE) trial, nested in the ongoing the "FRENCHIE" registry, a French multicenter prospective observational study granted by "ANR-RHU Grand Emprunt", in which all consecutive patients admitted within 48 hours after symptom onset in a cardiac Intensive Care Unit (ICU) for an acute myocardial infarction (AMI) are included (NCT04050956). Among them, eligible Patients for "APERITIF" will be randomized into two groups: Dual Anti-Platelet Therapy (DAPT) alone or DAPT plus rivaroxaban 2.5mg twice daily for 4 weeks, prescribed as soon as possible after admission and completion of the initial percutaneous coronary intervention/angiography procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAPT | Active Comparator | aspirin (≤100mg per day) and P2Y12 inhibitors (i.e. clopidogrel 75mg per day or ticagrelor 90mg twice a day), as per current guidelines |
|
| DAPT + Direct Oral AntiCoagulants (DOAC) | Experimental | aspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily) and rivaroxaban 2.5mg twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 2.5 MG [Xarelto] | Drug | Experimental group: usual DAPT strategy (aspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily)) + rivaroxaban 2.5mg twice daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of thrombus between the two arms | The main objective of this randomized trial is to determine whether, in anterior AMI patients (e.g., large necrosis area), the use of rivaroxaban 2.5mg twice daily in addition to DAPT (dual antiplatelet therapy) will reduce LV thrombus formation, compared with the use of DAPT alone (current practice). The primary endpoint is the presence of Left Ventricular (LV) thrombus at 1-month, as detected by the validated delayed enhancement (Cardiovascular Magnetic Resonance) CMR method | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the thrombus | LV thrombus dimension (greatest diameter) | 1 month |
| Rate of bleeding events | Rate of bleeding events using the Thrombolysis in Myocardial Infarction (TIMI) and the Bleeding Academic Research Consortium (BARC) criteria at 1 month (investigator-reported), |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Etienne PUYMIRAT | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HEGP | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41739450 | Derived | Puymirat E, Soulat G, Lattuca B, Bouleti C, Delarche N, Roubille F, Cottin Y, Bression D, Combaret N, Gerbaud E, Lhermusier T, Biere L, Dubreuil O, Mousseaux E, Steg PG, Cayla G, Lemesle G, Silvain J, Dillinger JG, Georges JL, Ducrocq G, Genet T, Morelle JF, Montalescot G, Berard L, Rousseau A, Soen M, Simon T, Danchin N; APERITIF study investigators. Low-Dose Rivaroxaban to Prevent Left Ventricular Thrombosis After Anterior Myocardial Infarction: The APERITIF Randomized Clinical Trial. JAMA Cardiol. 2026 Apr 1;11(4):323-331. doi: 10.1001/jamacardio.2026.0026. | |
| 37716448 |
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| DAPT strategy | Drug | usual DAPT strategy (aspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily)) + |
|
| 1 month |
| Rate of major adverse cardiac events (MACE) at 1 month | Rate of major adverse cardiac events (MACE) defined as a composite of death, non-fatal MI or stroke at 1 month | 1 month |
| Rate of major adverse cardiac events (MACE) at 1 year | Rate of major adverse cardiac events (MACE) defined as a composite of death, non-fatal MI or stroke at 1-year | 1 year |
| Rate of antithrombotic using | Antithrombotic drugs used in the patients with confirmed LV thrombus on CMR between 1 month and 1 year | 1 year |
| Derived |
| Puymirat E, Soulat G, Fayol A, Mousseaux E, Montalescot G, Cayla G, Steg PG, Berard L, Rousseau A, Drouet E, Simon T, Danchin N; APERITIF study investigators. Rationale and design of the direct oral anticoagulants for prevention of left ventricular thrombus after anterior acute myocardial infarction (APERITIF) trial. Am Heart J. 2023 Dec;266:98-105. doi: 10.1016/j.ahj.2023.09.005. Epub 2023 Sep 14. |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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