Aspirin Versus Aspirin and Fondaparinux Prior to Early Invasive Strategy in Patients With NSTEMI

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Aarhus University Hospital, Department of Cardiology
RECRUITING
Aarhus N
Contact Information
Primary
Christian B Fur, MD
chbyni@rm.dk
+4524918071
Backup
Christian J Terkelsen, MD, PhD, DmSC
christian.terkelsen@skejby.rm.dk
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2029-07-01
Participants
Target number of participants: 5076
Treatments
Experimental: Aspirin alone
Treatment with aspirin alone. The intervention is removal of treatment with fondaparinux
Active_comparator: Standard Treatment - Aspirin and Fondaparinux
Standard treatment regime with Aspirin in combination with Fondaparinux.
Related Therapeutic Areas
Sponsors
Collaborators: Sydvestjysk Hospital Esbjerg, Regional Hospital Gødstrup, Lillebaelt Hospital, Kolding and Vejle, Denmark, Viborg Regional Hospital, Danske Regioner, Odense University Hospital, Randers Regional Hospital, Hospital of Southern Jutland, Horsens Hospital, Aalborg University Hospital, Rigshospitalet, Denmark
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov