FOXY Trial
DAEN

For healthcare professionals

FOXY Trial design and clinical overview

An overview of eligibility, randomized treatment, endpoints, and follow-up according to the trial protocol.

Eligibility

Who is eligible?

Inclusion criteria

  • Verified NSTEMI
  • Age ≥18 years
  • Expected remaining lifespan ≥1 year
  • Capacity to provide written and oral informed consent

Exclusion criteria

  • Treatment with anticoagulants (DOACs, warfarin, or dalteparin, etc.)
  • CAG and PCI not possible within 72 hours
  • Unsuitable for CAG and possible PCI because of poor clinical condition
  • eGFR <20 mL/min/1.73 m²
  • Known liver disease
  • Active bleeding or high bleeding risk where fondaparinux is contraindicated
  • Haemoglobin <6.0 mmol/L
  • Pregnancy or breastfeeding
  • Endocarditis
  • Indication for acute CAG before enrolment

Interventions

Treatment groups

Participants are randomized 1:1, stratified by sex and site.

Aspirin alone

  • 300 mg loading dose
  • 75 mg once daily

No routine anticoagulation.

Aspirin + fondaparinux

  • 300 mg aspirin loading dose
  • 75 mg aspirin once daily
  • 2.5 mg fondaparinux SC once daily
During PCI UFH administered in both groups according to local practice
Timing Target: CAG (or CTCA) within 72 hours of randomization.

Non-inferiority design

Interpreting non-inferiority

Hypothetical estimates illustrating how non-inferiority is assessed for the 30-day primary endpoint. Upper CI bound must remain below margin to conclude non-inferiority.

8.0% Expected control
event rate
+2.2 pp NI margin
(relative margin 1.275)
80% Power
97.5% One-sided CI

Endpoints

Primary and safety endpoints

Primary efficacy endpoint 30 days

Composite of:

  • 30-day mortality
  • 30-day recurrent MI
  • Clinical deterioration Resulting in acute CAG before the scheduled
Safety endpoints 30 days
  • Major bleeding (BARC ≥3)
  • Severe thrombotic events Acute MI · CVA
Secondary endpoints View prespecified secondary endpoints
Death or new MI 180 days · 1 · 3 · 5 · 10 years
Cerebrovascular events · 30 days Ischemic stroke · TIA
In-hospital measures Length of stay · LVEF at discharge · TIMI flow

Follow-up

Short-term and Long-term

30 days

Electronic medical records

Primary and safety outcomes

1 · 3 · 5 · 10 years

Danish national registries

Long-term outcomes

No study-specific follow-up visits are required

This website provides general information about the FOXY Trial and does not replace the approved trial protocol or other trial-specific documentation.