Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06710184

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

Led by University of Aarhus · Updated on 2026-05-04

5076

Participants Needed

10

Research Sites

217 weeks

Total Duration

On this page

Sponsors

U

University of Aarhus

Lead Sponsor

D

Danske Regioner

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of NSTEMI confirmed by rise or fall in cardiac troponin and symptoms or ECG changes of acute ischemia
  • Age above 18 years
  • Expected to live more than 1 year
  • Able to give informed consent
Not Eligible

You will not qualify if you...

  • Currently treated with any anticoagulant medication including DOAC, LMWH, UFH, or warfarin
  • Unable to have coronary angiography and PCI within 72 hours
  • Too ill for coronary angiography or possible PCI
  • Kidney function (eGFR) below 20 ml/min/1.73m2
  • Known liver disease
  • Active bleeding or high bleeding risk contraindicating fondaparinux
  • Hemoglobin less than 6.0 mmol/l (anemia)
  • Pregnant or breastfeeding
  • Endocarditis
  • Indication for urgent coronary angiography before enrollment such as STEMI, very high risk conditions including hemodynamic instability, cardiogenic shock, acute heart failure from ischemia, life-threatening arrhythmias or cardiac arrest, or mechanical heart complications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 10 locations

1

Regionshospitalet Gødstrup

Herning, Region Midt, Denmark, 7400

Actively Recruiting

2

Regionshospitalet Horsens

Horsens, Region Midt, Denmark, 8700

Not Yet Recruiting

3

Regionshospitalet Viborg

Viborg, Region Midt, Denmark

Actively Recruiting

4

Aalborg Universitetshospital

Aalborg, Region Nord, Denmark, 9000

Not Yet Recruiting

5

Sygehus Søndejylland, Aabenraa

Aabenraa, Region Syd, Denmark, 6200

Actively Recruiting

6

Esbjerg Sygehus

Esbjerg, Region Syd, Denmark, 6700

Not Yet Recruiting

7

Sygehus Lillebælt, Kolding

Kolding, Region Syd, Denmark, 6000

Actively Recruiting

8

Odense Universitetshospital

Odense, Region Syd, Denmark, 5000

Actively Recruiting

9

Sygehus Lillebælt, Vejle

Vejle, Region Syd, Denmark, 7100

Actively Recruiting

10

Aarhus University Hospital, Department of Cardiology

Aarhus N, Denmark, 8200

Actively Recruiting

Loading map...

Research Team

C

Christian B Fur, MD

CONTACT

C

Christian J Terkelsen, MD, PhD, DmSC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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