Overview
Sponsor-declared trial summary
ST elevation myocardial infarction (STEMI)
To assess whether direct omission of aspirin after primary PCI with the continuation of ticagrelor monotherapy for 12 months versus 12 months ticagrelor plus aspirin is equally safe regarding the incidence of ischemic events in STEMI patients. Furthermore, the two treatment strategies will be compared regarding the inc…
Key facts
- Sponsor
- Radboud universitair medisch centrum Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Trial duration
- 20 Sep 2024 → ongoing
- Decision date (initial)
- 2024-09-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517783-37-00
- EudraCT number
- 2022-003218-36
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
To assess whether direct omission of aspirin after primary PCI with the continuation of ticagrelor monotherapy for 12 months versus 12 months ticagrelor plus aspirin is equally safe regarding the incidence of ischemic events in STEMI patients. Furthermore, the two treatment strategies will be compared regarding the incidence and extent of IMH in the first week after PCI
Conditions and MedDRA coding
ST elevation myocardial infarction (STEMI)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Clinical and electrocardiographical diagnosis of STEMI
- Successful PCI (according to the treating physician) of the infarct-related vessel with a modern DES
Exclusion criteria 13
- Known allergy or contraindication for aspirin, ticagrelor or prasugrel.
- Previous PCI or MI less than 12 months ago
- Previous cardiac surgery
- Participation in another clinical cardiology study or study concerning platelet aggregation/ thrombosis (unless the antithrombotic therapy prescribed in this other study will end due to clinical reasons (e.g. the STEMI))
- Pregnancy and breast feeding
- Concurrent use of oral anticoagulants (OAC)
- The periprocedural use of GPIIb/IIIa inhibitors
- Planned surgical intervention within 12 months of PCI
- Creatinine clearance <30 mL/min or dialysis
- PCI of stent thrombosis
- Suboptimal stent result as judged by the interventional cardiologist
- Life expectancy shorter than 13 months
- Contra-indications for MRI or unable to undergo MRI (only applicable for the CMR subgroup population)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Composite of major adverse cardiac and cerebral events (MACCE), consisting of: Myocardial infarction; Stent thrombosis; Ischemic stroke;Cardiovascular mortality.
- Infarct size and size of IMH determined by CMR at day 5-8 post-PPCI.
Secondary endpoints 5
- Bleeding complications BARC ≥ 2
- All-cause mortality
- To compare platelet reactivity between ticagrelor monotherapy and ticagrelor + ASA.
- To assess the anti-inflammatory effects of ticagrelor with or without aspirin on the inflammation response elicited by the myocardial infarction.
- To assess coagulation factors after the myocardial infarction in patients using ticagrelor with or without aspirin.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Acetylsalicylzuur Aurobindo cardio 80 mg, tabletten.
PRD594121 · Product
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 9999 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC06 — ACETYLSALICYLIC ACID
- Marketing authorisation
- RVG 26865
- 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
Radboud universitair medisch centrum Stichting
- Sponsor organisation
- Radboud universitair medisch centrum Stichting
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Peter Damman
Public contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Peter Damman
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 200 | 5 |
| 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 |
|---|---|---|---|---|---|
| Netherlands | 2024-09-20 | 2024-09-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Onderzoeksprotocol_STOP IMH_unredacted | 1.5 |
| Recruitment arrangements (for publication) | K1_blank_document_Recruitment_arrangements | 1 |
| Subject information and informed consent form (for publication) | Proefpersoneninformatie en toestemmingsverklaring STOP IMH_redacted | 1.3 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC acetylsalicylzuur | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-05 | Netherlands | Acceptable with conditions 2024-09-20
|
2024-09-20 |