Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ongoing, recruiting
Participants planned
5,076
Countries
1
Sites
18
Non-ST-Elevation Myocardial Infarction (NSTEMI)
To compare efficacy in patients treated with aspirin alone compared to combination therapy with fondaparinux and aspirin prior to early invasive strategy in patients with NSTEMI.
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 30 Apr 2025 → ongoing
- Decision date (initial)
- 2025-01-22
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To compare efficacy in patients treated with aspirin alone compared to combination therapy with fondaparinux and aspirin prior to early invasive strategy in patients with NSTEMI.
Secondary objectives 1
- To evaluate and compare the relative bleeding risk associated with the use of aspirin alone and in combination with fondaparinux prior to an invasive strategy in patients with NSTEMI
Conditions and MedDRA coding
Non-ST-Elevation Myocardial Infarction (NSTEMI)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10088133 | NSTEMI | 100000004848 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Diagnosis of NSTEMI verified by: Rise or/and fall in cardiac troponin and symptoms of acute schema or ECG-changes compatible with acute schema
- Age > 18 years of age
- Expected remaining lifespan > 1 year
- Independent capacity to act and provide informed written and oral consent
Exclusion criteria 10
- Treatment with any anticoagulants before enrollment and randomization
- 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
- Endocarditis
- Active bleeding or high risk of bleeding where treatment with Fondaparinux is contraindicated
- Anemia (B-Hemoglobin < 6.0 mmol/l)
- Pregnancy or breastfeeding
- Indication for acute CAG before enrollment and randomization, such as STEMI or patients classified as "Very High Risk" according to ESC 2023 Guidelines
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Composite endpoint of: 30-day mortality, 30-day new MI and refractory ischemia resulting in acute CAG before scheduled
Secondary endpoints 4
- Composite of occurrence of death or new MI within 180 days, 1 year, 3 years, 5 years and 10 years.
- Incidence cerebrovascular accident (CVA) within 30 days including: Ischemic stroke and Transient ischemic attack (TIA)
- Length of hospital stay
- Left ventricular ejection fraction (LVEF) at discharge
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB12504MIG · Substance
- Active substance
- Fondaparinux Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 17.5 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12504MIG · Substance
- Active substance
- Fondaparinux Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 1.5 mg milligram(s)
- Max total dose
- 10.5 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
SUB12730MIG · Substance
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12730MIG · Substance
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 750 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Hjertesygdomme AUH
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Hjertesygdomme AUH
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring, Code 8 |
Locations
1 EU/EEA country · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 5,076 | 18 |
| Rest of world | — | 0 | — |
Investigational sites
Region Midtjylland
Hjertesygdomme, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Esbjerg Og Grindsted Sygehus
Hjertesygdomme, Finsensgade 35, 6700, Esbjerg
Region Midtjylland
Medicinske afdeling | Hjertesygdomme, Skovlyvej 15, 8930, Randers Noe
Sygehus Soenderjylland Soenderborg
Hjertesygdomme, Kresten Philipsens Vej 15, 6200, Aabenraa
Aalborg University Hospital
Hjertesygdomme, Hobrovej 18-22, 9000, Aalborg
Region Midtjylland
Hjertesygdomme, Heibergs Alle 4, 8800, Viborg
Region Midtjylland
Hjertesygdomme, Sundvej 30, 8700, Horsens
Region Hovedstaden
Cardiology, Dyrehavevej 29, 3400, Hilleroed
Odense University Hospital
Hjertesygdomme, J B Winsloews Vej 4, 5000, Odense C
Region Hovedstaden
Hjertesygdomme, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Lillebaelt Hospital
Hjertesygdomme, Sygehusvej 24, 6000, Kolding
Rigshospitalet
Hjertesygdomme, Blegdamsvej 9, 2100, Copenhagen Oe
Regionshospital Nordjylland
Cardiology, Bispensgade 37, 9800, Hjoerring
Region Hovedstaden
Cardiology, Kettegaard Alle 36, 2650, Hvidovre
Region Midtjylland
Hjertesygdomme, Hospitalsparken 15, 7400, Herning
Lillebaelt Hospital
Hjertesygdomme, Beriderbakken 4, 7100, Vejle
Gentofte Hospital
Hjertesygdomme, Gentofte Hospitalsvej 1, 2900, Hellerup
Odense University Hospital
Department of Medicine | Cardiology, Baagoees Alle 15, 5700, Svendborg
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2025-04-30 | 2025-04-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Study Protocol | 2.0.2 |
| Protocol (for publication) | Study Protocol v2-0-2 - Track Changes | 1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements | 1.0.1 |
| Subject information and informed consent form (for publication) | Deltagerinformation + informed consent - Skabelon | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | Summary of product characteristics | 1 |
| Synopsis of the protocol (for publication) | Synopsis | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-30 | Denmark | Acceptable 2025-01-17
|
2025-01-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-10 | Denmark | Acceptable 2025-02-28
|
2025-02-28 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-20 | Denmark | Acceptable 2025-09-22
|
2025-09-22 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-07 | Denmark | Acceptable 2026-04-17
|
2026-04-17 |