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Treatment With Aspirin Alone Versus Aspirin in Combination With Fondaparinux Before Early Coronary Assessment in Patients With Non-ST-Elevation Myocardial Infarction

RecruitingPhase 4Ages 18 Years - anyAllUniversity of Aarhus
NCT06710184 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 prac

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📋 Eligibility rules (as published)
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)
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What it tests

  • Aspirin
  • Fondaparinux Sodium
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Where

10 sites
Regionshospitalet Gødstrup
Herning, Denmark
Regionshospitalet Horsens
Horsens, Denmark
Regionshospitalet Viborg
Viborg, Denmark
Aalborg Universitetshospital
Aalborg, Denmark
Sygehus Søndejylland, Aabenraa
Aabenraa, Denmark
Esbjerg Sygehus
Esbjerg, Denmark
Sygehus Lillebælt, Kolding
Kolding, Denmark
Odense Universitetshospital
Odense, Denmark

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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