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Antiplatelet Agent

DAPT + Direct Oral AntiCoagulants (DOAC) for Heart Attack (APERITIF Trial)

Phase 3
Waitlist Available
Led By Etienne PUYMIRAT
Research Sponsored by Assistance Publique - Hôpitaux de Paris
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Pivotal Trial
Approved for 20 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

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 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.

Eligible Conditions
  • Heart Attack
  • Left Ventricular Thrombus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of thrombus between the two arms
Secondary study objectives
Description of the thrombus
Rate of antithrombotic using
Rate of bleeding events
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DAPT + Direct Oral AntiCoagulants (DOAC)Experimental Treatment2 Interventions
aspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily) and rivaroxaban 2.5mg twice daily.
Group II: DAPTActive Control1 Intervention
aspirin (≤100mg per day) and P2Y12 inhibitors (i.e. clopidogrel 75mg per day or ticagrelor 90mg twice a day), as per current guidelines
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rivaroxaban
FDA approved
DAPT strategy
2021
Completed Phase 3
~560

Find a Location

Who is running the clinical trial?

Assistance Publique - Hôpitaux de ParisLead Sponsor
3,255 Previous Clinical Trials
56,909,991 Total Patients Enrolled
Etienne PUYMIRATPrincipal InvestigatorAssistance Publique - Hôpitaux de Paris
~140 spots leftby Nov 2025
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