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Compares treatment options for NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)
Official title Treatment With Aspirin Alone Versus Aspirin in Combination With Fondaparinux Before Early Coronary Assessment in Patients With Non-ST-Elevation Myocardial Infarction
ClinicalTrials.gov ID: NCT06710184
What this study is testing
What is Aspirin?
Aspirin is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for nstemi - non-st segment elevation myocardial infarction (mi).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Herning, Region Midt, Denmark
- Horsens, Region Midt, Denmark
- Viborg, Region Midt, Denmark
- Aalborg, Region Nord, Denmark
- Aabenraa, Region Syd, Denmark
- Esbjerg, Region Syd, Denmark
- Kolding, Region Syd, Denmark
- Odense, Region Syd, Denmark
- Vejle, Region Syd, Denmark
- Aarhus N, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herning, Region Midt, Denmark; Horsens, Region Midt, Denmark; Viborg, Region Midt, Denmark; Aalborg, Region Nord, Denmark; Aabenraa, Region Syd, Denmark; Esbjerg, Region Syd, Denmark and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.