Overview
Sponsor-declared trial summary
non-ST-elevation myocardial infarction (NSTEMI), ST-elevation myocardial infarction (STEMI), coronary artery disease
To assess whether the number of clinical endpoints (MACCE) can be reduced by antibiotic treatment, targeting mainly bacteria that have in previous studies been shown to be involved in complex atherosclerotic plaques, such as those found in patients suffering from acute myocardial infarction.
Key facts
- Sponsor
- TAYS Sydaenkeskus Oy
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-08-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To assess whether the number of clinical endpoints (MACCE) can be reduced by antibiotic treatment, targeting mainly
bacteria that have in previous studies been shown to be involved in complex atherosclerotic plaques, such as those found
in patients suffering from acute myocardial infarction.
Conditions and MedDRA coding
non-ST-elevation myocardial infarction (NSTEMI), ST-elevation myocardial infarction (STEMI), coronary artery disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Clinically diagnosed ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI)
- Invasive strategy has been chosen, i.e. angiography is performed
- Age ≥18 years
- Informed consent has been obtained
- at least 3 of following high risk criteria are met (hypertension, DM, moderate renal insufficiency eGFR<60ml/min, peripheral arterial disease ASO, multivessel coronary artery disease, previous myocardial infraction, previous stroke or TIA)
Exclusion criteria 12
- Cardiogenic shock
- Probable finding of SCAD (spontaneous coronary dissection)
- Definite coronary embolism
- Severe valvular disease
- On-going bleeding or very high bleeding risk
- < 1 year life expectancy
- On-going antibiotic therapy
- Severe allergy to contrast agents or ASA
- Allergy to cephalosporin
- On-going methotrexate medication
- Clinical diagnosis of Takotsubo syndrome
- Pregnancy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Major adverse cardiac and cerebrovascular events (MACCE) in 12 months follow-up, including: cardiovascular death, myocardial infarction, hospitalization for NYHA IV heart failure, stroke or transient ischemic attack (TIA)
Secondary endpoints 3
- Individual components of the primary end point at 12 months
- MACCE at 3 months
- MACCE at 2 and 5 years
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Ceftriaxon Navamedic 2 g infuusiokuiva-aine, liuosta varten
PRD11970659 · Product
- Active substance
- Ceftriaxone
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 00 g gram(s)
- Max total dose
- 00 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DD04 — -
- Marketing authorisation
- 20157
- MA holder
- NAVAMEDIC ASA
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Amoxin 500 mg kalvopäällysteinen tabletti
PRD11942803 · Product
- Active substance
- Amoxicillin Trihydrate
- Substance synonyms
- AMOXYCILLIN TRIHYDRATE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA04 — AMOXICILLIN
- Marketing authorisation
- 11517
- MA holder
- RATIOPHARM GMBH
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
TAYS Sydaenkeskus Oy
- Sponsor organisation
- TAYS Sydaenkeskus Oy
- Address
- P. O. Box 2000
- City
- Tampere
- Postcode
- 33521
- Country
- Finland
Scientific contact point
- Organisation
- TAYS Sydaenkeskus Oy
- Contact name
- Jussi Hernesniemi
Public contact point
- Organisation
- TAYS Sydaenkeskus Oy
- Contact name
- Kati Helleharju
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 1,070 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-522136-14-00_ public | 1 |
| Protocol (for publication) | D1_Protocol_2025-522136-14-00_public_v2.1 | 1 |
| Recruitment arrangements (for publication) | K1_Recruiment arrangements_public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_2025-522136-14-00 public | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPc_Amoxin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPc_Ceftriaxon Navmedic | 1 |
| Synopsis of the protocol (for publication) | D1_protocol synopsis_FI EU 2025-522136-14-00_public | 1 |
| Synopsis of the protocol (for publication) | D1_protocol synopsis_FI EU 2025-522136-14-00_v 2.1 public | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-11 | Finland | Acceptable 2025-08-20
|
2025-08-27 |