Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
1,316
Countries
1
Sites
29
Stroke
To investigate whether discontinuation of antiplatelet therapy is non-inferior to continuation of antiplatelet therapy, to prevent major cardiovascular events three to ten years after cryptogenic TIA or ischaemic stroke at young age.
Key facts
- Sponsor
- Stichting Radboud universitair medisch centrum
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 5 Dec 2024 → ongoing
- Decision date (initial)
- 2024-08-04
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Netherlands Organisation for Health Research and Development (ZonMw)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To investigate whether discontinuation of antiplatelet therapy is non-inferior to continuation of antiplatelet therapy, to prevent major cardiovascular events three to ten years after cryptogenic TIA or ischaemic stroke at young age.
Secondary objectives 4
- To investigate whether discontinuation of antiplatelet therapy after cryptogenic stroke or TIA at young age reduces risk of major bleeding.
- To investigate whether discontinuation of antiplatelet therapy after cryptogenic stroke or TIA at young age reduces all-cause mortality.
- To investigate whether discontinuation of antiplatelet therapy after cryptogenic stroke or TIA at young age improves quality of life
- To investigate whether discontinuation of antiplatelet therapy after cryptogenic stroke or TIA at young age is cost-effective
Conditions and MedDRA coding
Stroke
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- First ever ischaemic stroke, or TIA with evidence of ischaemia on imaging, 3-10 years prior to study participation
- Age 18-49 years at the time of TIA/ischaemic stroke
- Cryptogenic aetiology, defined as no other aetiology after standard work-up according to national and international guidelines for young stroke (imaging of the brain (CT-scan or MRI-scan) and cervical arteries (CTA, MRA or carotid ultrasound), routine blood tests (complete blood count, erythrocyte sedimentation rate, CRP, antiphospholipid antibodies), ECG, at least 24 hours cardiac rhythm monitoring and transthoracic/transesophageal echocardiography).
Exclusion criteria 7
- History of MI, coronary revascularisation or documented peripheral arterial disease
- Other indication for antiplatelet therapy
- Indication for oral anticoagulants or low molecular weight heparin
- Recurrent ischaemic event at any time after the index event
- Any stenosis of intracranial or cervical artery at time of stroke
- Two or more risk factors for atherosclerotic disease according to the following definitions: • arterial hypertension (treated or known blood pressure before stroke >140/90 mm Hg) • diabetes mellitus (treated or known blood fasting glucose >7 mmol/l) • current smoking (or smoking stopped within the last 6 months), • hypercholesterolaemia (treated or known low-density lipoprotein before the stroke >160 mg/dl or 4, mmol/l)
- Any condition that prevents long-term follow-up
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- A composite endpoint of major vascular events, defined as TIA with imaging confirmation, stroke, myocardial infarction, or death from vascular causes.
Secondary endpoints 4
- Major bleeding
- All-cause mortality
- Cost-effectiveness
- Quality of life
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Clopidogrel Viatris 75 mg film-coated tablets
PRD10095739 · Product
- Active substance
- Clopidogrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 260 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AC04 — CLOPIDOGREL
- Marketing authorisation
- EU/1/09/568/013
- MA holder
- VIATRIS LIMITED
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 3
SCP131039 · ATC
- Active substance
- Carbasalate Calcium
- Substance synonyms
- Carbaspirin calcium
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 146000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC06 — ACETYLSALICYLIC ACID
- Marketing authorisation
- -
- 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
- 19500 mg milligram(s)
- Max treatment duration
- 260 Week(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
SCP12713335 · ATC
- Active substance
- Dipyridamole
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 730000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC07 — DIPYRIDAMOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Radboud universitair medisch centrum
- Sponsor organisation
- Stichting Radboud universitair medisch centrum
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- Frank-Erik de Leeuw
Public contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- Frank-Erik de Leeuw
Locations
1 EU/EEA country · 29 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 1,316 | 29 |
| Rest of world | — | 0 | — |
Investigational sites
Stichting OLVG
Neurology, Oosterpark 9, 1091 AC, Amsterdam
Bernhoven B.V.
Neurology, Nistelrodeseweg 10, 5406 PT, Uden
Gelre Hospitals
Neurology, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn
Universiteit Maastricht
Neurology, P Debyelaan 25, 6229 HX, Maastricht
Deventer Ziekenhuis
Neurology, Nico Bolkesteinlaan 75, 7416 SE, Deventer
Amphia Hospital
Neurology, Molengracht 21, 4818 CK, Breda
Stichting Elisabeth-Tweesteden Ziekenhuis
Neurology, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Maasstad Ziekenhuis Stichting
Neurology, Maasstadweg 21, 3079 DZ, Rotterdam
Catharina Ziekenhuis Stichting
Neurology, Michelangelolaan 2, 5623 EJ, Eindhoven
Jeroen Bosch Ziekenhuis Stichting
Neurology, Henri Dunantstraat 1, 5223 GZ, 'S-Hertogenbosch
Isala Klinieken Stichting
Neurology, Dokter Van Heesweg 2, 8025 AB, Zwolle
Sint Franciscus Vlietland Groep Stichting
Neurology, Kleiweg 500, 3045 PM, Rotterdam
Universitair Medisch Centrum Groningen
Neurology, Hanzeplein 1, 9713 GZ, Groningen
Reinier de Graaf Groep
Neurology, Reinier De Graafweg 5, 2625 AD, Delft
Leids Universitair Medisch Centrum (LUMC)
Neurology, P. O. Box 9600, 2300 RC, Leiden
Medisch Spectrum Twente
Neurology, Koningsplein 1, 7512 KZ, Enschede
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Neurology, Dr. Molewaterplein 60, 3015 GJ, Rotterdam
Rijnstate Ziekenhuis Stichting
Neurology, Wagnerlaan 55, 6815 AD, Arnhem
Albert Schweitzer Ziekenhuis
Neurology, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Canisius Wilhelmina Ziekenhuis
Neurology, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
Universitair Medisch Centrum Utrecht
Neurology, Heidelberglaan 100, 3584 CX, Utrecht
Radboud universitair medisch centrum / RADBOUDUMC
Neurology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Academisch Medisch Centrum
Neurology, Meibergdreef 9, 1105 AZ, Amsterdam
Medisch Centrum Leeuwarden B.V.
Neurology, Henri Dunantweg 2, 8934 AD, Leeuwarden
Haaglanden Medisch Centrum Stichting
Neurology, Lijnbaan 32, 2512 VA, 'S-Gravenhage
Spaarne Gasthuis Stichting
Neurology, Boerhaavelaan 24, 2035 RC, Haarlem
Zuyderland Medisch Centrum Stichting
Neurology, Henri Dunantstraat 5, 6419 PC, Heerlen
Haga Hospital
Neurology, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Alrijne Zorggroep Stichting
Neurology, Simon Smitweg 1, 2353 GA, Leiderdorp
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-12-05 | 2024-12-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-513092-40 | 9.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K2 Radboudumc_website_STOPtrial_dec2025 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_redacted | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_low litteracy | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Acetylsalicylzuur 80mg NL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Clopidogrel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dipyridamole NL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Justification for not uploading IB or SmPC | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-513092-40 (EN) | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS 2024-513092-40 (NL) | 1 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-09 | Netherlands | Acceptable with conditions 2024-08-04
|
2024-08-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-05 | Netherlands | Acceptable 2024-11-14
|
2024-11-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-19 | Netherlands | Acceptable 2025-03-06
|
2025-03-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-02 | Netherlands | Acceptable 2025-05-19
|
2025-05-19 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-15 | Netherlands | Acceptable 2025-08-06
|
2025-08-06 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-02 | Netherlands | Acceptable 2026-01-15
|
2026-02-12 |