Aspirin alone versus aspirin plus fondaparinux before early coronary angiography for NSTEMI
Aspirin Versus Aspirin and Fondaparinux Prior to Early Invasive Strategy in Patients With NSTEMI
This trial will test whether giving aspirin alone or aspirin plus the anticoagulant fondaparinux before early coronary angiography is better and safer for adults with NSTEMI.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 5076 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 10 sites (Herning, Region Midt and 9 other locations) |
| Trial ID | NCT06710184 on ClinicalTrials.gov |
What this trial studies
Patients with confirmed NSTEMI who are planned for early coronary angiography (usually within 72 hours) are randomized to receive either aspirin alone or aspirin plus fondaparinux before the procedure. Treatments are given prior to coronary angiography, and patients may undergo PCI (balloon/stent) if indicated. The trial excludes patients already on anticoagulants, those with very low kidney function, active bleeding, or other high bleeding risk, and those needing immediate emergency angiography. Outcomes focus on balancing ischemic protection with bleeding risk in the context of modern early invasive care.
Who should consider this trial
Good fit: Adults with a confirmed NSTEMI who can undergo coronary angiography within 72 hours, are not on anticoagulants, and do not have severe renal or liver disease, active bleeding, or other contraindications to fondaparinux.
Not a fit: Patients already on anticoagulants, those with STEMI or who need immediate invasive care, those with very low eGFR, active bleeding, or pregnancy are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the study could show that aspirin alone provides similar protection with less bleeding and simpler care compared with adding fondaparinux.
How similar studies have performed: Older randomized trials showed benefit for fondaparinux in some NSTEMI populations, but those trials largely predate routine early invasive management, so the question remains in current practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Diagnosis of NSTEMI verified by:
* 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
* Informed consent
Exclusion Criteria:
* 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
* Estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2
* Known liver disease
* Active bleeding or high risk of bleeding where treatment with Fondaparinux is contraindicated.
* Anemia (B-Hemoglobin \< 6.0 mmol/l)
* Pregnancy or breastfeeding
* Endocarditis
* Indication for acute CAG before enrollment and randomization:
* ST-elevation Myocardial Infarction (STEMI)
* Patients classified as "Very High Risk" according to ESC guidelines, defined as(1):
* Hemodynamic instability (in need of inotropic support) or cardiogenic shock (DANGER-SHOCK criteria (20)) at time of admission.
* Acute heart failure because of presumed acute ischemia
* Life-threatening arrhythmias or cardiac arrest
* Mechanical complications (such as papillary muscle rupture with acute mitral regurgitation, free wall rupture and interventricular rupture)
Where this trial is running
Herning, Region Midt and 9 other locations
- Regionshospitalet Gødstrup — Herning, Region Midt, Denmark (Recruiting)
- Regionshospitalet Horsens — Horsens, Region Midt, Denmark (Not_yet_recruiting)
- Regionshospitalet Viborg — Viborg, Region Midt, Denmark (Recruiting)
- Aalborg Universitetshospital — Aalborg, Region Nord, Denmark (Not_yet_recruiting)
- Sygehus Søndejylland, Aabenraa — Aabenraa, Region Syd, Denmark (Recruiting)
- Esbjerg Sygehus — Esbjerg, Region Syd, Denmark (Not_yet_recruiting)
- Sygehus Lillebælt, Kolding — Kolding, Region Syd, Denmark (Recruiting)
- Odense Universitetshospital — Odense, Region Syd, Denmark (Recruiting)
- Sygehus Lillebælt, Vejle — Vejle, Region Syd, Denmark (Recruiting)
- Aarhus University Hospital, Department of Cardiology — Aarhus N, Denmark (Recruiting)
Study contacts
- Study coordinator: Christian B Fur, MD
- Email: chbyni@rm.dk
- Phone: +4524918071
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.