Actively Recruiting
Treatment With Aspirin Alone Versus Aspirin in Combination With Fondaparinux Before Early Coronary Assessment in Patients With Non-ST-Elevation Myocardial Infarction
Led by University of Aarhus · Updated on 2026-05-04
5076
Participants Needed
10
Research Sites
217 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
D
Danske Regioner
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment With Aspirin Alone Versus Aspirin in Combination With Fondaparinux Before Early Coronary Assessment in Patients With Non-ST-Elevation Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of NSTEMI confirmed by rise or fall in cardiac troponin and symptoms or ECG changes of acute ischemia
- Age above 18 years
- Expected to live more than 1 year
- Able to give informed consent
You will not qualify if you...
- Currently treated with any anticoagulant medication including DOAC, LMWH, UFH, or warfarin
- Unable to have coronary angiography and PCI within 72 hours
- Too ill for coronary angiography or possible PCI
- Kidney function (eGFR) below 20 ml/min/1.73m2
- Known liver disease
- Active bleeding or high bleeding risk contraindicating fondaparinux
- Hemoglobin less than 6.0 mmol/l (anemia)
- Pregnant or breastfeeding
- Endocarditis
- Indication for urgent coronary angiography before enrollment such as STEMI, very high risk conditions including hemodynamic instability, cardiogenic shock, acute heart failure from ischemia, life-threatening arrhythmias or cardiac arrest, or mechanical heart complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Regionshospitalet Gødstrup
Herning, Region Midt, Denmark, 7400
Actively Recruiting
2
Regionshospitalet Horsens
Horsens, Region Midt, Denmark, 8700
Not Yet Recruiting
3
Regionshospitalet Viborg
Viborg, Region Midt, Denmark
Actively Recruiting
4
Aalborg Universitetshospital
Aalborg, Region Nord, Denmark, 9000
Not Yet Recruiting
5
Sygehus Søndejylland, Aabenraa
Aabenraa, Region Syd, Denmark, 6200
Actively Recruiting
6
Esbjerg Sygehus
Esbjerg, Region Syd, Denmark, 6700
Not Yet Recruiting
7
Sygehus Lillebælt, Kolding
Kolding, Region Syd, Denmark, 6000
Actively Recruiting
8
Odense Universitetshospital
Odense, Region Syd, Denmark, 5000
Actively Recruiting
9
Sygehus Lillebælt, Vejle
Vejle, Region Syd, Denmark, 7100
Actively Recruiting
10
Aarhus University Hospital, Department of Cardiology
Aarhus N, Denmark, 8200
Actively Recruiting
Research Team
C
Christian B Fur, MD
CONTACT
C
Christian J Terkelsen, MD, PhD, DmSC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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