Overview
Sponsor-declared trial summary
Acute coronary syndrome and chronic coronary syndrome
This study will assess the feasibility and safety of a single antiplatelet strategy with a reduced dose of prasugrel 5 mg after percutaneous coronary intervention in acute and chronic coronary syndrome patients.
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 13 Nov 2025 → ongoing
- Decision date (initial)
- 2025-07-18
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520351-24-00
- ClinicalTrials.gov
- NCT06916520
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
This study will assess the feasibility and safety of a single antiplatelet strategy with a reduced dose of prasugrel 5 mg after percutaneous coronary intervention in acute and chronic coronary syndrome patients.
Secondary objectives 2
- The study will evaluate treatment satisfaction and treatment adherence in single antiplatelet strategy compared to dual antiplatelet strategy.
- The study will evaluate the occurrence of high on-treatment platelet reactivity in a small subset of patients (the first 40 patients who undergo platelet reactivity testing).
Conditions and MedDRA coding
Acute coronary syndrome and chronic coronary syndrome
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Acute coronary intervention
- Chronic coronary syndrome
- Successfull PCI (according tot treating physician)
Exclusion criteria 6
- Known allergy or contraindication for prasugrel (including active pathological bleeding, severe liver disease (defined as Child Pugh class C))
- Current indication for oral anticoagulant therapy (OAC)
- Indication for ongoing DAPT (e.g. PCI ≤ 6 months for CCS or ACS ≤ 12 months)
- Pregnancy or breast-feeding women
- Participation in another trial with an investigational drug or device
- Recent or ongoing use of CYP2B6 substrates with a narrow therapeutic window
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Net Adverse Clinical Events (NACE), a composite of all-cause mortality, myocardial infarction, definite stent thrombosis, ischemic stroke, major bleeding or clinically relevant non-major bleeding defined as BARC type 2, 3 or 5
Secondary endpoints 11
- Treatment satisfaction, based on the Treatment Satisfaction Questionnaire for Medication II (TSQM-II)
- Treatment adherence, based on the Morisky Medication Adherence Scale (MMAS-8)
- Each individual component of the primary endpoint
- Cardiovascular mortality
- Non-cardiovascular mortality
- Any need for revascularization
- Major or clinically relevant non-major bleeding defined as BARC type 2, 3 or 5
- Minor or clinically relevant non-major bleeding defined as BARC type 2 at 1, 6 and 12 month(s)
- Any periprocedural complications
- On-treatment platelet reactivity at week 2 in the first 40 patients
- Non-adherence to antiplatelet regimen
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Efient 5 mg film-coated tablets.
PRD9985400 · Product
- Active substance
- Prasugrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 1885 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC22 — -
- Marketing authorisation
- EU/1/08/503/001
- MA holder
- SUBSTIPHARM
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- S. Sivanesan
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- S. Sivanesan
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 300 | 2 |
| 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 | 2025-11-13 | 2025-11-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-520351-24-00 | 1.6 |
| Protocol (for publication) | D4_Patient facing documents questionnaire | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1.3 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Prasugrel | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2024-520351-24-00 | 1.2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-04 | Netherlands | Acceptable with conditions 2025-07-18
|
2025-07-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-04 | Netherlands | Acceptable 2025-10-09
|
2025-10-09 |