Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
146
Countries
1
Sites
1
Postoperative Atrial Fibrillation
To prevent incidence of postoperative atrial fibrillation on patients undergoing cardiothoracic surgery
Key facts
- Sponsor
- Stichting Amsterdam UMC
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2024-09-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Innovation Exchange Amsterdam (IXA) · Atrial Fibrilltion Innnovation Platform (AFIP)
External identifiers
- EU CT number
- 2024-514743-28-00
- WHO UTN
- U1111-1301-9293
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
To prevent incidence of postoperative atrial fibrillation on patients undergoing cardiothoracic surgery
Secondary objectives 1
- The secondary trial endpoints are assessments of activation of HSPs by biochemical analysis and microscopic imaging; in blood, atrial tissue and epicardial adipose tissue.
Conditions and MedDRA coding
Postoperative Atrial Fibrillation
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-000655-36 | Evaluation of GeranylGeranylAcetone in heart failure with preserved ejection fraction |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Aged between 18 and 80 years old
- Elected for cardiothoracic surgery for mitral valve stenosis or regurgitation, and/or aortic valve stenosis or regurgitation, and/or coronary artery disease
Exclusion criteria 8
- Documented history of AF
- Not able to undergo the complete study protocol
- Previous cardiothoracic surgery
- Doubt about compliance
- Pre-menopausal women who are nursing, pregnant, or of child-bearing potential
- Chronic malabsorption
- Any documented or suspected malignancy or history of malignancy within 1 year prior to screening, except appropriate treated basal cell carcinoma or in situ carcinoma of the cervix
- Currently enrolled in another drug trial
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Assessment of Postoperative atrial fibrillation incidence, by Holter monitoring
Secondary endpoints 1
- The secondary trial endpoints are assessments of activation of HSPs by biochemical analysis and microscopic imaging; in blood, atrial tissue and epicardial adipose tissue
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB15486MIG · Substance
- Active substance
- Teprenone
- Pharmaceutical form
- GRANULES
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 2400 mg milligram(s)
- Max treatment duration
- 8 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Medium-chain triglycerides (Miglyol 812N), CAS Number: 73398-61-5
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Amsterdam UMC
- Sponsor organisation
- Stichting Amsterdam UMC
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Amsterdam UMC
- Contact name
- Principal Investigator
Public contact point
- Organisation
- Stichting Amsterdam UMC
- Contact name
- Principal Investigator
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Stichting Amsterdam UMC ORG-100008355
|
Amsterdam, Netherlands | Laboratory analysis |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 146 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Stichting Amsterdam UMC
Physiology/Cardiothoracic surgery, Meibergdreef 9, 1105 AZ, Amsterdam
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-12 | Netherlands | Acceptable 2024-09-20
|
2024-09-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-20 | Netherlands | Acceptable 2024-09-20
|
2025-01-20 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-01-21 | Netherlands | Acceptable 2024-09-20
|
2025-01-21 |