Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
590
Countries
2
Sites
4
Acute ischemic stroke
The overall objective of this study is to demonstrate that the efficacy of DOACs is superior to the standard of care (SOC, i.e. treatment with antiplatelets until study end or until AF is detected) for the prevention of stroke recurrence in MR-proANP selected acute ischemic stroke patients without known AF on admission…
Key facts
- Sponsor
- Universitaetsspital Basel
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-01-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Swiss National Science Foundation · BRAHMS GmbH
External identifiers
- EU CT number
- 2024-517600-11-01
- EudraCT number
- 2019-002404-41
- ClinicalTrials.gov
- NCT03961334
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
The overall objective of this study is to demonstrate that the efficacy of DOACs is superior to the standard of care (SOC, i.e. treatment with antiplatelets until study end or until AF is detected) for the prevention of stroke recurrence in MR-proANP selected acute ischemic stroke patients without known AF on admission.
Conditions and MedDRA coding
Acute ischemic stroke
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-517600-11-00 | MidregiOnal proatrial natriuretic peptide to guide SEcondary Stroke prevention: The MOSES-study | University Hospital Zurich |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- MR-proANP level ≥200pmol/L within 72 hours from symptom onset, Age ≥ 18 years, Clinical diagnosis of ischemic stroke, Written informed consent according to country specific details
Exclusion criteria 1
- History of AF, AF on 12-lead ECG on admission or any AF ≥30 seconds during heart-rhythm monitoring prior to randomization; Other condition that require anticoagulant therapy (e.g., venous thromboembolism) as per Investigator’s judgment including therapeutic dose of low-molecularweight heparin or heparin; Strong likelihood to be treated with prolonged (i.e. more than 90 days) dual antiplatelet therapy during the course of the trial (such as coronary stenting, etc.); Patients undergoing planned procedures where therapy with a DOAC is a contraindication (e.g. acute surgery); Previous intracranial symptomatic hemorrhage in the last 24 months; Evidence of severe cerebral amyloid angiopathy if MRI scan performed; Chronic kidney disease with creatinine clearance <30ml/min and or subject who requires haemodialysis or peritoneal dialysis; Known bleeding diathesis (e.g. active peptic ulcer disease, platelet count < 100’000/mm3 or haemoglobin < 8 g/dl or INR ≥ 1.7, documented haemorrhagic tendencies or blood dyscrasias); Active infective endocarditis; Known allergy or intolerance to antiplatelets or DOACs; Female who is pregnant or lactating or has a positive pregnancy test at time of admission; If restricted by national law: Current participation in another drug trial
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary outcome measure is the time to any recurrent stroke within 1 year after the index ischemic stroke.
Secondary endpoints 1
- Composite of major bleeding, recurrent stroke and/or vascular death (whichever occurs first) within 1 year after the index ischemic stroke; single components of the composite outcome above
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD300197 · Product
- Active substance
- Dabigatran Etexilate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 220 mg milligram(s)
- Max total dose
- 86900 mg milligram(s)
- Max treatment duration
- 13 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AE07 — -
- Marketing authorisation
- EU/1/08/442/005
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD298739 · Product
- Active substance
- Dabigatran Etexilate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 118500 mg milligram(s)
- Max treatment duration
- 13 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AE07 — -
- Marketing authorisation
- EU/1/08/442/009
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Eliquis 2.5 mg film-coated tablets
PRD2351235 · Product
- Active substance
- Apixaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 1975 mg milligram(s)
- Max treatment duration
- 13 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AF02 — -
- Marketing authorisation
- EU/1/11/691/001
- MA holder
- BRISTOL-MYERS SQUIBB/PFIZER EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lixiana 30 mg film-coated tablets
PRD2965666 · Product
- Active substance
- Edoxaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 11850 mg milligram(s)
- Max treatment duration
- 13 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AF03 — -
- Marketing authorisation
- EU/1/15/993/002
- MA holder
- DAIICHI SANKYO EUROPE GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lixiana 60 mg film-coated tablets
PRD2965685 · Product
- Active substance
- Edoxaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 23700 mg milligram(s)
- Max treatment duration
- 13 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AF03 — -
- Marketing authorisation
- EU/1/15/993/003
- MA holder
- DAIICHI SANKYO EUROPE GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Eliquis 5 mg film-coated tablets
PRD2351268 · Product
- Active substance
- Apixaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 3950 mg milligram(s)
- Max treatment duration
- 13 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AF02 — -
- Marketing authorisation
- EU/1/11/691/012
- MA holder
- BRISTOL-MYERS SQUIBB/PFIZER EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
Aspirine 100, 100 mg Tabletten
PRD1724895 · Product
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 39500 mg milligram(s)
- Max treatment duration
- 13 Month(s)
- Authorisation status
- Authorised
- ATC code
- N02BA01, B01AC06 — ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID
- Marketing authorisation
- BE163581
- MA holder
- BAYER SA NV
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Plavix 75 mg film-coated tablets
PRD2912264 · Product
- Active substance
- Clopidogrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 29625 mg milligram(s)
- Max treatment duration
- 13 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC04 — CLOPIDOGREL
- Marketing authorisation
- EU/1/98/069/001
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsspital Basel
- Sponsor organisation
- Universitaetsspital Basel
- Address
- Petersgraben 4
- City
- Basel
- Postcode
- 4031
- Country
- Switzerland
Scientific contact point
- Organisation
- Universitaetsspital Basel
- Contact name
- Mira Katan
Public contact point
- Organisation
- Universitaetsspital Basel
- Contact name
- Mira Katan
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Hellenic Institute for the Study of Sepsis ORL-000012600
|
Athens, Greece | Code 12, Code 14, Code 5 |
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Greece | Authorised, recruitment pending | 40 | 1 |
| Spain | Authorised, recruitment pending | 150 | 3 |
| Rest of world
Switzerland
|
— | 400 | — |
Investigational sites
Hospital De La Santa Creu I Sant Pau
Unitat de Malalties Vasculars Cerebrals - Stroke Unit, Carrer de Sant Quintí, 89, Barcelona
Hospital Universitario Virgen Macarena
Neurology, Avda. Dr. Fedriani 3, 41009, Sevilla
University Hospital Virgen Del Rocio S.L.
Neurology, Avda. Manuel Siurot, s/n, Sevilla
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 24 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | MOSES English Protocol V1.2 | 1.2 |
| Protocol (for publication) | MOSES Greek Protocol | 1.2 |
| Recruitment arrangements (for publication) | Selection of Participants | 1 |
| Recruitment arrangements (for publication) | Spain Recrtuitment arrangements | 1 |
| Subject information and informed consent form (for publication) | MOSES ICF GR | 1.1 |
| Subject information and informed consent form (for publication) | MOSES ICF Paciente V1 09MAR2021 HSP | 1 |
| Subject information and informed consent form (for publication) | MOSES ICF Paciente V1 09MAR2021 HVM | 1 |
| Subject information and informed consent form (for publication) | MOSES ICF Paciente V1 09MAR2021 HVR | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | plavix | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | salospir | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | AEMPS CEIM SPC Eliquis | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | AEMPS CEIM SPC Lixiana | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | AEMPS CEIM SPC Pradaxa | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Aspirin Smpc | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Aspirin SmPC engl | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Clopidogrel Smpc | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | IB Eliquis | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | IB Pradaxa | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Clopidogrel - Plavix engl | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Eliquis engl | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Lixiana engl | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Pradaxa engl | 1 |
| Synopsis of the protocol (for publication) | MOSES Greek Synopsis | 1.2 |
| Synopsis of the protocol (for publication) | MOSES Protocol Synopsis V1.2 | 1.2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-22 | Greece | Acceptable 2025-01-15
|
2025-01-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-30 | Greece | Acceptable 2026-05-29
|
2026-06-01 |