About this trial
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.
Eligibility criteria
Qualifiers
Rise or/and fall in cardiac troponin (cTN) and
Symptoms of acute ischemia or ECG-changes compatible with acute ischemia.
Age above 18 years old
Expected remaining lifespan above 1 year
Disqualifiers
Treatment with any anticoagulants before enrollment and randomization
Including any direct anticoagulant (DOAC), LMWH, UFH or warfarin.
Not possible with CAG and PCI within 72 hours
Unsuitable for CAG and possible PCI due to poor condition
Trial design
Treatments tested in this trial
- Aspirin
- Fondaparinux Sodium
Treatment groups
Sponsors and collaborators
University of Aarhus
Lead sponsor
Danske Regioner
Collaborator
Aalborg University Hospital
Collaborator
Odense University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
Randers Regional Hospital
Collaborator
Viborg Regional Hospital
Collaborator
Gødstrup Hospital
Collaborator
Sydvestjysk Hospital Esbjerg
Collaborator
Lillebaelt Hospital, Kolding and Vejle, Denmark
Collaborator
Hospital of Southern Jutland
Collaborator
Horsens Hospital
Collaborator