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.
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
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
Parallel
Aspirin
DrugAspirin bolus of 300 mg followed by 75 mg daily until CAG
Fondaparinux Sodium
DrugFondaprinux 2.5 mg subcutaneus daily until CAG (1.5 mg for patients with eGFR 20-50 ml/min/1.73m2)
Composite endpoint of mortality, new myocardial infarction, and clinical deterioration resulting in acute CAG
Composite of 30-day mortality, 30-day new MI, and clinical deterioration resulting in acute CAG. The endpoints will be assessed through review of the patient's medical journal. New Myocardial infarction (MI): Defined as a new MI after the early invasive strategy. Clinical deterioration resulting in acute CAG: Defined as conversion to acute coronary angiography (CAG) before the scheduled. Indication for acute CAG is based on the ESC guidelines of "very high risk" NSTEMI (1):
All-cause mortality
Assessed through danish registries
New Myocardial Infarction
Assessed through danish registries
Cerebrovascular accident (CVA)
Including ischemic stroke and Transient Ischemic Attack. Assessed through Danish registries
Length of hospital stay
From admission to discharge at enrollment. Will be assessed through registries and patients medical journal.
Severe bleeding
Safety Endpoint: Incidence of severe bleeding defined as BARC criteria equal or above 3 within 30 days.
Severe thrombotic event
Safety endpoint: Incidence of severe thrombotic events within 30 days including acute MI and CVA
Click on the lead sponsor to view all of their trials.
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
