Heart attack study tests if one drug is enough before stent procedure
NCT ID NCT06710184
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether using aspirin alone is as effective and safer than aspirin plus another blood thinner (fondaparinux) before a heart procedure in people with a type of heart attack called NSTEMI. About 5,000 participants will be randomly assigned to one of the two treatments and followed for 30 days. The goal is to see if aspirin alone can prevent death, new heart attacks, or urgent procedures while reducing the risk of severe bleeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 5,076 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aalborg Universitetshospital
NOT_YET_RECRUITINGAalborg, Region Nord, 9000, Denmark
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Aarhus University Hospital, Department of Cardiology
RECRUITINGAarhus N, 8200, Denmark
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Esbjerg Sygehus
NOT_YET_RECRUITINGEsbjerg, Region Syd, 6700, Denmark
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Odense Universitetshospital
RECRUITINGOdense, Region Syd, 5000, Denmark
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Regionshospitalet Gødstrup
RECRUITINGHerning, Region Midt, 7400, Denmark
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Regionshospitalet Horsens
NOT_YET_RECRUITINGHorsens, Region Midt, 8700, Denmark
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Regionshospitalet Viborg
RECRUITINGViborg, Region Midt, Denmark
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Sygehus Lillebælt, Kolding
RECRUITINGKolding, Region Syd, 6000, Denmark
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Sygehus Lillebælt, Vejle
RECRUITINGVejle, Region Syd, 7100, Denmark
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Sygehus Søndejylland, Aabenraa
RECRUITINGAabenraa, Region Syd, 6200, Denmark
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- Can a temporary heart pump save more lives in cardiogenic shock?