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Myocardial Infarction, AcutePhase 3APERITIFNCT05077683

Direct Oral Anticoagulants for Prevention of lEft ventRIcular Thrombus After Anterior Acute Myocardial InFarction - APERITIF

A Phase 3 study testing Rivaroxaban 2.5 MG [Xarelto] and DAPT strategy in people with Myocardial Infarction, Acute and Left Ventricular Thrombus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rivaroxaban 2.5 MG [Xarelto] and DAPT strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
560 participants
Where
1 siteFrance
Study dates
10 Oct 2021to 9 Feb 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years;
  • Anterior STEMI (e.g., ST elevation above the J-point of ≥0.1 millivolt in ≥two contiguous leads or left bundle branch block) or very high-risk NSTEMI (e.g., dynamic ECG changes or ongoing chest pain or acute heart failure or hemodynamic instability independent of ECG changes or life-threatening ventricular arrhythmias) with echographic evidence of anterior wall motion abnormalities and, with a culprit lesion of the proximal or mid portion of the left anterior descending (LAD) on the coronary angiography;
  • No contraindication to CMR (e.g., claustrophobia, pacemaker or defibrillator not compatible);
  • Ability to provide written informed consent and willing to participate in 1-month follow-up period.
  • Affiliation of social security regime.

Who cannot join

  • Patients with cardiogenic shock (systolic blood pressure <90 mmHg with clinical signs of low output or patients requiring inotropic agents);
  • Patients referred to surgery for coronary artery bypass grafting (CABG) or treatment of acute complications (e.g. ventricular septal rupture);
  • Patients treated with fibrinolytic therapy;
  • LV thrombus diagnosed before randomization using a transthoracic echocardiography;
  • Active major bleeding or major surgery within the last 30 days;High bleeding risk (patients considered at increased risk of bleeding during DAPT; e.g. PRECISE-DAPT score >25; severe liver failure or Child Pugh class C);
  • Known history of intracranial hemorrhagic stroke or intra-cranial aneurysm;
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  • Known history of peptic ulcer;
  • Known stroke (any type) within the last 30 days;
  • Known intolerance to aspirin, P2Y12 inhibitors, rivaroxaban and their excipients;
  • Patients with presence of malignant neoplasms at high risk of bleeding
  • Patients with hepatic impairment
  • According to the SmPC any contraindication to rivaroxaban, aspirin, clopidogrel, ticagrelor
  • Known intolerance to gadolinium chelates;
  • Chronic kidney disease (creatinine clearance (ClCr) <30 mL/min);
  • Indication for anticoagulation (e.g. atrial fibrillation, mechanical valves, LV thrombus…);
  • Life expectancy <1 month;
  • Known pregnancy at time of randomization (pregnancy test done) or breastfeeding women;
  • Currently participating in another trial
  • Protected adults (including individual under guardianship by court order)
  • Persons deprived of their liberty by judicial or administrative decision

Trial locations and contacts

1 site in 1 country.

France1 site

  • HEGP

    Paris

Other trials in France

About this study

Official title: Direct Oral Anticoagulants for Prevention of lEft ventRIcular Thrombus After Anterior Acute Myocardial InFarction

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.

Being tested
Rivaroxaban 2.5 MG [Xarelto], DAPT strategy
Keywords
Myocardial infarction, Left ventricular thrombus
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • DAPT strategyDrug

    usual DAPT strategy (aspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily)) +

Study groups in NCT05077683
Study groupRoleWhat they receive
DAPTActive comparatoraspirin (≤100mg per day) and P2Y12 inhibitors (i.e. clopidogrel 75mg per day or ticagrelor 90mg twice a day), as per current guidelines
Receives: Drug: DAPT strategy
DAPT + Direct Oral AntiCoagulants (DOAC)Experimentalaspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily) and rivaroxaban 2.5mg twice daily.
Receives: Drug: Rivaroxaban 2.5 MG [Xarelto]; Drug: DAPT strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 month

Secondary outcomes (5)

  1. Description of the thrombus

    LV thrombus dimension (greatest diameter)

    Measured: 1 month

  2. 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),

    Measured: 1 month

  3. 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

    Measured: 1 month

  4. 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

    Measured: 1 year

  5. Rate of antithrombotic using

    Antithrombotic drugs used in the patients with confirmed LV thrombus on CMR between 1 month and 1 year

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2021
  2. Study start10 Oct 2021
  3. Primary completion10 Mar 2023
  4. Study completion9 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
560 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05077683
Sponsor's protocol ID
APHP200015
Other IDs
2021-001534-19
Acronym
APERITIF
Status last verified
Jul 2023
First submitted
27 Sep 2021
Last updated
10 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 41739450

  • 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.

    PubMed 37716448

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban 2.5 MG [Xarelto] and DAPT strategy in people with Myocardial Infarction, Acute and Left Ventricular Thrombus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of thrombus between the two arms (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05077683, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.

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