Clinical trial • Cardiology

FONDAPARINUX SODIUM for Non-ST-elevation myocardial infarction (NSTEMI)

Clinical trial of FONDAPARINUX SODIUM for Non-ST-elevation myocardial infarction (NSTEMI).

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Non-ST-elevation myocardial infarction (NSTEMI)
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
30-10-2024
First CTIS Authorization Date
22-01-2025

Trial design

Randomised, aspirin (acetylsalicylic acid) — oral film-coated tablet; max daily dose reported 300 mg (product entries list maxdailydoseamount 300 mg); fondaparinux sodium — solution for injection, subcutaneous; standard dose reported 2.5 mg daily (product entry maxdailydoseamount 2.5 mg) with reduced dose 1.5 mg for patients with egfr 20-50 ml/min. trial compares aspirin alone versus aspirin plus fondaparinux.-controlled trial across 18 sites in Denmark.

Randomised
Yes
Comparator
Aspirin (acetylsalicylic acid) — oral film-coated tablet; max daily dose reported 300 mg (product entries list maxDailyDoseAmount 300 mg); Fondaparinux sodium — solution for injection, subcutaneous; standard dose reported 2.5 mg daily (product entry maxDailyDoseAmount 2.5 mg) with reduced dose 1.5 mg for patients with eGFR 20-50 ml/min. Trial compares aspirin alone versus aspirin plus fondaparinux.
Target Sample Size
5076

Eligibility

Recruits 5076 Vulnerable population not selected; inclusion requires 'Independent capacity to act and provide informed written and oral consent'. Informed consent form (template provided) must be signed by participants and includes permission to share anonymised individual participant data..

Pregnancy Exclusion
Pregnancy or breastfeeding
Vulnerable Population
Vulnerable population not selected; inclusion requires 'Independent capacity to act and provide informed written and oral consent'. Informed consent form (template provided) must be signed by participants and includes permission to share anonymised individual participant data.

Inclusion criteria

  • {"criterion_text":"- Diagnosis of NSTEMI verified by: Rise or/and fall in cardiac troponin and symptoms of acute schema or ECG-changes compatible with acute schema"}
  • {"criterion_text":"- Age > 18 years of age"}
  • {"criterion_text":"- Expected remaining lifespan > 1 year"}
  • {"criterion_text":"- Independent capacity to act and provide informed written and oral consent"}

Exclusion criteria

  • {"criterion_text":"- Treatment with any anticoagulants before enrollment and randomization"}
  • {"criterion_text":"- Indication for acute CAG before enrollment and randomization, such as STEMI or patients classified as \"Very High Risk\" according to ESC 2023 Guidelines"}
  • {"criterion_text":"- Not possible with CAG and PCI within 72 hours"}
  • {"criterion_text":"- Unsuitable for CAG and possible PCI due to poor condition"}
  • {"criterion_text":"- Estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2"}
  • {"criterion_text":"- Known liver disease"}
  • {"criterion_text":"- Endocarditis"}
  • {"criterion_text":"- Active bleeding or high risk of bleeding where treatment with Fondaparinux is contraindicated"}
  • {"criterion_text":"- Anemia (B-Hemoglobin < 6.0 mmol/l)"}
  • {"criterion_text":"- Pregnancy or breastfeeding"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Composite endpoint of: 30-day mortality, 30-day new MI and refractory ischemia resulting in acute CAG before scheduled","definition_or_measurement_approach":"Composite measured as occurrence within 30 days of: mortality, new myocardial infarction (MI), and refractory ischemia leading to acute coronary angiography (CAG) before the scheduled procedure."}

Secondary endpoints

  • {"endpoint_text":"- Composite of occurrence of death or new MI within 180 days, 1 year, 3 years, 5 years and 10 years.","definition_or_measurement_approach":"Composite outcome measured at specified follow-up timepoints (180 days, 1 year, 3 years, 5 years, 10 years) capturing death or new MI."}
  • {"endpoint_text":"- Incidence cerebrovascular accident (CVA) within 30 days including: Ischemic stroke and Transient ischemic attack (TIA)","definition_or_measurement_approach":"Incidence of ischemic stroke and transient ischemic attack (TIA) occurring within 30 days."}
  • {"endpoint_text":"- Length of hospital stay","definition_or_measurement_approach":"Duration of index hospital admission measured in days."}
  • {"endpoint_text":"- Left ventricular ejection fraction (LVEF) at discharge","definition_or_measurement_approach":"LVEF assessment at hospital discharge (echocardiographic measurement as recorded in clinical records)."}

Recruitment

Planned Sample Size
5076
Recruitment Window Months
30
Consent Approach
Adults must have independent capacity and provide informed written and oral consent ('Independent capacity to act and provide informed written and oral consent'). A subject information and informed consent form template is provided; the consent form includes permission to share anonymised individual participant data. No assent/minor consent procedures are described.

Geography

Total Number Of Sites
18
Total Number Of Participants
5076

Denmark

Earliest CTIS Part Ii Submission Date
09-01-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
463
Number Of Sites
18
Number Of Participants
5076

Sites

Site Name
Region Hovedstaden
Department Name
Hjertesygdomme
Contact Person Name
Gorm Mørk
Contact Person Email
gorm.moerk@regionh.dk
Site Name
Odense University Hospital
Department Name
Hjertesygdomme
Contact Person Name
Jens Flensted Lassen
Contact Person Email
Jens.Flensted.Lassen@rsyd.dk
Site Name
Lillebaelt Hospital
Department Name
Hjertesygdomme
Contact Person Name
Dilek Hunerel Alan
Contact Person Email
Dilek.Hunerel.Alan@rsyd.dk
Site Name
Region Midtjylland
Department Name
Hjertesygdomme
Contact Person Name
Morten Würtz
Contact Person Email
mortwurt@rm.dk
Site Name
Regionshospital Nordjylland
Department Name
Cardiology
Contact Person Name
Peter Bisgaard Stæhr
Contact Person Email
p.staehr@rn.dk
Site Name
Region Hovedstaden
Department Name
Cardiology
Contact Person Name
Jens Dahlgaard Hove
Contact Person Email
jens.dahlgaard.hove@regionh.dk
Site Name
Rigshospitalet
Department Name
Hjertesygdomme
Contact Person Name
Niels Thue Olsen
Contact Person Email
niels.thue.olsen@regionh.dk
Site Name
Region Hovedstaden
Department Name
Cardiology
Contact Person Name
Charlotte Kragelund
Contact Person Email
charlotte.kragelund@regionh.dk
Site Name
Aalborg University Hospital
Department Name
Hjertesygdomme
Contact Person Name
Ashkan Efterkhari
Contact Person Email
asef@rn.dk
Site Name
Gentofte Hospital
Department Name
Hjertesygdomme
Contact Person Name
Kristian Eskesen
Contact Person Email
kristian.eskesen@regionh.dk
Site Name
Esbjerg Og Grindsted Sygehus
Department Name
Hjertesygdomme
Contact Person Name
Christian Oliver Fallesen
Site Name
Region Midtjylland
Department Name
Hjertesygdomme
Contact Person Name
Claus Kjær Pedersen
Contact Person Email
Clapes@rm.dk
Site Name
Region Midtjylland
Department Name
Hjertesygdomme
Contact Person Name
Hanne Maare Søndergaard
Site Name
Region Midtjylland
Department Name
Hjertesygdomme
Contact Person Name
Christian Juhl Terkelsen
Site Name
Lillebaelt Hospital
Department Name
Hjertesygdomme
Contact Person Name
Remmon R Leo Francis Washington
Contact Person Email
remmon.washington2@rsyd.dk
Site Name
Sygehus Soenderjylland Soenderborg
Department Name
Hjertesygdomme
Contact Person Name
Ghassan Jadou
Contact Person Email
ghassan.jadou@rsyd.dk
Site Name
Region Midtjylland
Department Name
Medicinske afdeling | Hjertesygdomme
Contact Person Name
Bo Løfgren
Contact Person Email
borloe@rm.dk
Site Name
Odense University Hospital
Department Name
Department of Medicine | Cardiology
Contact Person Name
Jess Lambrechtsen
Contact Person Email
Jess.lambrechtsen@rsyd.dk

Sponsor

Primary sponsor

Full Name
Region Midtjylland
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties codes: 1, 8","organisation_type":"Educational Institution"}

Investigational products

Investigational Product Name
FONDAPARINUX SODIUM
Active Substance
FONDAPARINUX SODIUM
Modality
Small molecule
Routes Of Administration
Subcutaneous injection
Route
Subcutaneous injection
Authorisation Status
prodAuthStatus: 2
Starting Dose
2.5 mg
Dose Levels
2.5 mg; 1.5 mg (reduced dose for patients with eGFR 20-50 ml/min)
Frequency
Daily
Maximum Dose
maxTotalDoseAmount: 17.5 mg (standard); 10.5 mg (reduced dose)
Investigational Product Name
ACETYLSALICYLIC ACID (Aspirin)
Active Substance
ACETYLSALICYLIC ACID
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
prodAuthStatus: 2
Starting Dose
300 mg (max daily dose reported 300 mg)
Dose Levels
300 mg
Frequency
As per guideline-recommended dosing (daily)
Maximum Dose
maxTotalDoseAmount: 300 mg or up to 750 mg in other product entry
Combination Treatment
Yes

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