Treatment With Aspirin Alone Versus Aspirin in Combination With Fondaparinux Before Early Coronar… (NCT06710184) | Clinical Trial Compass
RecruitingPhase 4
Treatment With Aspirin Alone Versus Aspirin in Combination With Fondaparinux Before Early Coronary Assessment in Patients With Non-ST-Elevation Myocardial Infarction
Denmark5,076 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 4 trial comparing aspirin alone against aspirin plus fondaparinux in NSTEMI — since Phase 4 studies are done after a drug is already approved, does that mean the safety profile of fondaparinux is well established, and how does that change the risk picture for me specifically?
2The trial is measuring a combined outcome of death, another heart attack, and clinical deterioration requiring urgent coronary angiography — can you walk me through what each of those outcomes would mean in my situation, and how likely they are with my current condition?
3Since this trial involves an anticoagulant (fondaparinux) on top of aspirin, what bleeding risks would that combination carry for me personally, given my medical history?
4Is early coronary assessment — the kind being studied in this trial — already part of the standard treatment plan you're considering for me, or would joining this trial change the timing or approach to my care?
5Given that this trial is still actively recruiting, would waiting to be enrolled or randomized affect how quickly I receive treatment, and is there a standard-of-care option you'd recommend I consider first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite endpoint of mortality, new myocardial infarction, and clinical deterioration resulting in acute CAG
Timeframe: The primary endpoints will be assessed after day 30.