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Treatment With Aspirin Alone Versus Aspirin in Combination With Fondaparinux Before Early Coronary Assessment in Patients With Non-ST-Elevation Myocardial Infarction

Study acronym: FOXY
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Minor Study sites: 1 to 10v3
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary completion date: Jan 1, 2028 to Jan 1, 2029
    • Primary endpoint revised
    • Enrollment target: 5068 to 5076
    • Study completion date: Jul 1, 2028 to Jul 1, 2029
    • Start date changed from estimate of Feb 1, 2025 to May 1, 2025
    • Site details revised
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The main goal of this study is to compare two treatments in patients with a specific type of heart attack called Non-ST-elevation Myocardial Infarction (NSTEMI). The investigators want to find out whether using aspirin alone is as effective and safer than using aspirin together with a second blood thinner called fondaparinux. Both treatments will be given before a scheduled heart procedure called coronary angiography (CAG), which may include balloon dilation and stent placement (PCI) if needed. The current guidelines recommend using aspirin in combination with a second blood thinner like fondaparinux before CAG and possible PCI. However, these recommendations are based on studies from the 1990s, a time when invasive procedures were not standard practice for these patients. In contrast, nearly all patients with NSTEMI in Denmark (96%) now undergo CAG within 72 hours. This change in practice raises questions about whether the older studies still provide a valid foundation for today's guidelines. The study aims to answer two questions: 1. Is aspirin alone as effective as aspirin combined with fondaparinux before early CAG and possible PCI? 2. Is aspirin alone safer, with a lower risk of severe bleeding, compared to the combination treatment? To answer these questions, the investigators will enroll about 5,000 patients with NSTEMI. Participants will be randomly assigned to receive either aspirin alone or aspirin with fondaparinux. The investigators will monitor them for 30 days to compare outcomes such as death, new heart attacks, the need for urgent CAG before the scheduled, and severe bleeding.
Trial Details
NCT Number NCT06710184
Lead Sponsor University of Aarhus
Collaborators: Danske Regioner, Aalborg University Hospital, Odense University Hospital, Rigshospitalet, Denmark, Randers Regional Hospital, Viborg Regional Hospital, Gødstrup Hospital, Sydvestjysk Hospital Esbjerg, Lillebaelt Hospital, Kolding and Vejle, Denmark, Hospital of Southern Jutland, Horsens Hospital
Conditions
(from sponsor)
NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI), Acute Myocardial Infarction (AMI)
Related terms Ischemia
Enrollment 5,076 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov