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

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.

Conditions

• NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)
• Acute Myocardial Infarction (AMI)

Interventions

DRUG

Aspirin

Aspirin bolus of 300 mg followed by 75 mg daily until CAG

DRUG

Fondaparinux Sodium

Fondaprinux 2.5 mg subcutaneus daily until CAG (1.5 mg for patients with eGFR 20-50 ml/min/1.73m2)

Sponsors & Collaborators

• Danske Regioner

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Randers Regional Hospital

  collaborator OTHER

• Viborg Regional Hospital

  collaborator OTHER

• Gødstrup Hospital

  collaborator OTHER

• Sydvestjysk Hospital Esbjerg

  collaborator UNKNOWN

• Lillebaelt Hospital, Kolding and Vejle, Denmark

  collaborator UNKNOWN

• Hospital of Southern Jutland

  collaborator OTHER

• Horsens Hospital

  collaborator OTHER

• University of Aarhus

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-01

Primary Completion

2029-01-01

Completion

2029-07-01

Countries

• Denmark

Study Locations