Aspirin alone versus aspirin plus fondaparinux before early coronary angiography for NSTEMI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Regionshospitalet Gødstrup
  Herning, Region Midt, Denmark Recruiting
• Regionshospitalet Viborg
  Viborg, Region Midt, Denmark Recruiting
• Sygehus Søndejylland, Aabenraa
  Aabenraa, Region Syd, Denmark Recruiting
• Sygehus Lillebælt, Kolding
  Kolding, Region Syd, Denmark Recruiting
• Odense Universitetshospital
  Odense, Region Syd, Denmark Recruiting
• Sygehus Lillebælt, Vejle
  Vejle, Region Syd, Denmark Recruiting

Study contacts

• Study coordinator: Christian B Fur, MD
• Email: chbyni@rm.dk
• Phone: +4524918071

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.