NCT06710184 Treatment With Aspirin Alone Versus Aspirin in Combination With Fondaparinux Before Early Coronary Assessment in Patients With Non-ST-Elevation Myocardial Infarction

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 5,076 participants in total. It began in 2025-05-01 with a primary completion date of 2029-01-01.

Brief Summary

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.

Eligibility 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)

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