Overview
Sponsor-declared trial summary
Myocardial ischemia Myocardial infarction
The objective of this trial is to examine the effect of immediate versus late administration of beta blockers, angiotensin converting enzyme inhibitors (ACEI), and sodium/glucose cotransporter 2 (SGLT2) inhibitors on echocardiographic parameters and biomarkers in subjects with ST-elevation myocardial infarction (STEMI)…
Key facts
- Sponsor
- Vaestra Goetalandsregionen, University Of Gothenburg
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 5 Jan 2025 → ongoing
- Decision date (initial)
- 2024-06-27
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- University of Gothenburg · Region Västra Götaland
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
The objective of this trial is to examine the effect of immediate versus late administration of beta blockers, angiotensin converting enzyme inhibitors (ACEI), and sodium/glucose cotransporter 2 (SGLT2) inhibitors on echocardiographic parameters and biomarkers in subjects with ST-elevation myocardial infarction (STEMI).
Conditions and MedDRA coding
Myocardial ischemia Myocardial infarction
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10064345 | ST segment elevation myocardial infarction | 10007541 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Patients with STEMI who undergo primary PCI within 6 hours of symptom onset* (*Excluding prodromal symptoms)
- Informed consent
Exclusion criteria 7
- Killip class ≥ 3
- Pre-existing non-reversible cardiac dysfunction or heart failure
- Current treatment with any beta blocker, RAAS inhibitor or SGLT2 inhibitor
- Absolute or relative contraindication to any one of the study drugs that confers a risk of patient safety if the patient participates in the trial and adheres to the protocol-specified recommendations, per the assessment of the treating physician
- Life expectancy less than one year
- Pregnancy or women of childbearing potential who is not sterilized or is not using a medically accepted form of contraception.
- Additional exclusion criteria for the CMRI sub-study of the trial: 7. Any absolute contraindication for CMRI
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Global longitudinal strain (GLS, %) at day 7±24 hours after PCI, adjusted for baseline (day 0) GLS.
Secondary endpoints 5
- Left ventricular ejection fraction (LVEF), adjusted for baseline LVEF
- NT-proBNP on day 7, adjusted for baseline NT-proBNP
- Area under the curve of cardiac troponin-T at day 30
- Area under the curve of cardiac troponin-I at day 30
- Infarct size at 30 days (assessed by cardiac magnetic resonance imaging [CMRI])
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
SUB13096MIG · Substance
- Active substance
- Bisoprolol
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10.0 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB31650 · Substance
- Active substance
- Dapagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10248MIG · Substance
- Active substance
- Ramipril
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 1 Month(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
Vaestra Goetalandsregionen
- Sponsor organisation
- Vaestra Goetalandsregionen
- Address
- Regionens Hus
- City
- Vänersborg
- Postcode
- 462 80
- Country
- Sweden
Scientific contact point
- Organisation
- University Of Gothenburg
- Contact name
- Björn Redfors
Public contact point
- Organisation
- University Of Gothenburg
- Contact name
- Björn Redfors
University Of Gothenburg
- Sponsor organisation
- University Of Gothenburg
- Address
- P. O. Box 100
- City
- Gothenburg
- Postcode
- 405 30
- Country
- Sweden
Scientific contact point
- Organisation
- University Of Gothenburg
- Contact name
- Björn Redfors
Public contact point
- Organisation
- University Of Gothenburg
- Contact name
- Björn Redfors
Sponsor responsibilities
- Article 77 compliance
- Vaestra Goetalandsregionen
- Contact point sponsor
- Vaestra Goetalandsregionen
- Article 77 implementation
- Vaestra Goetalandsregionen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 120 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Sweden | 2025-01-05 | 2025-01-05 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-08 | Sweden | Acceptable 2024-06-19
|
2024-06-27 |