Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
3,090
Countries
2
Sites
25
Non-ST-segment elevation acute coronary syndrome
This study will assess whether omitting aspirin reduces the rate of major or minor bleeding while remaining non-inferior to the current standard of care with regards to ischemic events in patients with non-ST segment elevation acute coronary syndrome.
Key facts
- Sponsor
- Amsterdam UMC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Trial duration
- 13 May 2022 → ongoing
- Decision date (initial)
- 2023-10-19
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-504360-42-00
- EudraCT number
- 2021-005550-28
- ClinicalTrials.gov
- NCT05125276
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
This study will assess whether omitting aspirin reduces the rate of major or minor bleeding while remaining non-inferior to the current standard of care with regards to ischemic events in patients with non-ST segment elevation acute coronary syndrome.
Conditions and MedDRA coding
Non-ST-segment elevation acute coronary syndrome
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina)
- Successful PCI (according to the treating physician)
Exclusion criteria 6
- Known allergy or contraindication for aspirin or all commercially available P2Y12-inhibitors (i.e. ticagrelor, prasugrel and clopidogrel)
- Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation)
- Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS)
- Planned surgical intervention within 12 months of PCI
- Pregnant or breastfeeding women at time of enrolment
- Participation in another trial with an investigational drug or device
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Major or minor bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding at 12 months
- Composite of all-cause mortality, myocardial infarction, and stroke at 12 months
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Acetylsalicylzuur Cardio Aurobindo 80 mg, dispergeerbare tabletten.
PRD1772702 · Product
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- DISPERSIBLE TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 37200 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC06 — ACETYLSALICYLIC ACID
- Marketing authorisation
- RVG 102607
- MA holder
- AUROBINDO PHARMA B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC
- Sponsor organisation
- Amsterdam UMC
- Address
- Meibergdreef 9
- City
- Amsterdam
- Postcode
- 1105 AZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC
- Contact name
- I.T. Küçük
Public contact point
- Organisation
- Amsterdam UMC
- Contact name
- I.T. Küçük
Locations
2 EU/EEA countries · 25 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 400 | 7 |
| Netherlands | Ongoing, recruitment ended | 2,690 | 18 |
| Rest of world | — | 0 | — |
Investigational sites
Imelda
Cardiology, Imeldalaan 9, 2820, Bonheiden
Het Ziekenhuisnetwerk Antwerpen
Cardiology, Lindendreef 1, 2020, Antwerp
UZ Leuven
Cardiology, Herestraat 49, 3000, Leuven
CHC MontLegia
Cardiology, Boulev. De Patience Et Beajonc 2, 4000, Liege
CHU Helora
Cardiology, Rue Ferrer 159 Boite 1, 7100, La Louviere
Onze Lieve Vrouw Ziekenhuis
cardiology, Moorselbaan 164, 9300, Aalst
UZ Brussel
Cardiology, Laarbeeklaan 101, 1090, Jette
St Antonius Hospital
Cardiology, Koekoekslaan 1, 3435 CM, Nieuwegein
Utrecht University
Cardiology, Heidelberglaan 100, 3584 CX, Utrecht
Medisch Centrum Leeuwarden B.V.
Cardiology, Henri Dunantweg 2, 8934 AD, Leeuwarden
Stichting Treant Ziekenhuiszorg
Cardiology, Boermarkeweg 60, 7824 AA, Emmen
Stichting Rijnstate Ziekenhuis
Cardiology, Wagnerlaan 55, 6815 AD, Arnhem
Amsterdam UMC
Cardiology, De Boelelaan 1118, 1081 HZ, Amsterdam
Haga Hospital
Cardiology, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Stichting OLVG
Cardiology, Oosterpark 9, 1091 AC, Amsterdam
Stichting Radboud University Medical Center
Cardiology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Stichting Zuyderland Medisch Centrum
Cardiology, Henri Dunantstraat 5, 6419 PC, Heerlen
Tergooiziekenhuizen
Cardiology, Van Riebeeckweg 212, 1213 XZ, Hilversum
Amsterdam UMC
Cardiology, Meibergdreef 9, 1105 AZ, Amsterdam
Noordwest Ziekenhuisgroep Stichting
Cardiology, Wilhelminalaan 12, 1815 JD, Alkmaar
Leiden University Medical Center
Cardiology, Albinusdreef 2, 2333 ZA, Leiden
Maastricht University
Cardiology, P Debyelaan 25, 6229 HX, Maastricht
Jeroen Bosch Ziekenhuis
Cardiology, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch
Isala Klinieken Stichting
Cardiology, Dokter Van Heesweg 2, 8025 AB, Zwolle
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Cardiology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
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 |
|---|---|---|---|---|---|
| Belgium | 2024-01-26 | 2024-01-26 | 2025-10-28 | ||
| Netherlands | 2022-05-13 | 2022-05-13 | 2025-10-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements (for publication) | Blank document | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | Addendum L1_SIS and ICF | 1.0 |
| Subject information and informed consent form (for publication) | D4_Patient facing documents accomponying letter questionnaire | 1 |
| Subject information and informed consent form (for publication) | D4_Patient facing documents EQ-5D-5L questionnaire Dutch | 1 |
| Subject information and informed consent form (for publication) | D4_Patient facing documents EQ-5D-5L questionnaire French | 1 |
| Subject information and informed consent form (for publication) | D4_Patient facing documents studiekaart | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF French | 1.3 |
| Subject information and informed consent form (for publication) | SponsorStatement ICF redacted | 1 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-10 | Netherlands | Acceptable 2023-04-03
|
2023-04-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-06-02 | Netherlands | Acceptable 2023-07-17
|
2023-07-28 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2023-08-11 | 2023-10-19 | ||
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-11-06 | Acceptable | 2024-01-26 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-12-22 | Netherlands | Acceptable | 2024-01-25 |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-02-28 | Netherlands | Acceptable 2024-04-22
|
2024-04-23 |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-05-08 | Netherlands | Acceptable | 2024-07-10 |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2024-05-27 | Acceptable 2024-04-22
|
||
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-07-08 | Acceptable | 2024-08-26 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-09-17 | Acceptable | 2024-10-28 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-11 | 2024-10-09 | Netherlands | Acceptable | 2024-12-02 |