Overview
Sponsor-declared trial summary
Non-ST-segment Elevation Acute Coronary Syndrome
1. To assess ischemic risk (i.e. efficacy) of genotype-guided clopidogrel monotherapy during the first 6 months following successful PCI in NSTE-ACS patients. 2. To assess bleeding risk (i.e. safety) of genotype-guided clopidogrel monotherapy during the first 6 months following successful PCI in NSTE-ACS patients.
Key facts
- Sponsor
- Sint Antonius Ziekenhuis Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 15 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518464-12-00
- EudraCT number
- 2022-003061-38
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Pharmacogenetic, Safety
1. To assess ischemic risk (i.e. efficacy) of genotype-guided clopidogrel monotherapy during the first 6 months following successful PCI in NSTE-ACS patients.
2. To assess bleeding risk (i.e. safety) of genotype-guided clopidogrel monotherapy during the first 6 months following successful PCI in NSTE-ACS patients.
Secondary objectives 1
- The secondary endpoints includes the individual components of the primary safety and efficacy endpoints at 1 and 6 months.
Conditions and MedDRA coding
Non-ST-segment Elevation Acute Coronary Syndrome
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age 18 or older
- Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina)
- Successful PCI (according to the treating physician)
- CYP2C19 extensive or ultra-rapid metabolizer
Exclusion criteria 10
- CYP2C19 poor or intermediate metabolizer
- Pregnant or breastfeeding women at time of enrolment
- Participation in another trial with an investigational drug or device
- Known allergy or contraindication for aspirin or 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)
- High-risk features for PCI including left main disease, chronic total occlusion, bifurcation lesion requiring 2-stent treatment, saphenous or arterial graft lesion, severely calcified lesion requiring the use of the Rotablator system, ≥3 treated vessels, ≥ 3 stents implanted and total stent length >60 mm
- Recent stroke, transient ischemic attack (TIA) or intracranial bleeding
- Severe hepatic impairment (Child Pugh class C)
- Planned surgical intervention within 6 months of PCI
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- The primary ischemic endpoints at 6 months is the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis, and ischemic stroke
- The primary bleeding endpoint at 6 months is major or minor bleeding (BARC type 2, 3 or 5 bleeding)
Secondary endpoints 6
- Primary ischemic and bleeding endpoint at 1 month
- Each individual component of the primary endpoints at 1 and 6 months
- Cardiovascular mortality at 1 and 6 months.
- Non-cardiovascular mortality at 1 and 6 months.
- Any need for revascularization at 1 and 6 months.
- Any periprocedural complications.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Clopidogrel 75 mg film-coated tablets
PRD11227919 · Product
- Active substance
- Clopidogrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 999 mg milligram(s)
- Max treatment duration
- 999 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC04 — CLOPIDOGREL
- Marketing authorisation
- PL 08553/0766
- MA holder
- DR. REDDY'S LABORATORIES (UK) LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Acetylsalicylzuur Cardio Teva 80 mg
PRD557052 · Product
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- DISPERSIBLE TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 999 mg milligram(s)
- Max treatment duration
- 999 Month(s)
- Authorisation status
- Authorised
- ATC code
- N02BA01, B01AC06 — ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID
- Marketing authorisation
- RVG 16466
- MA holder
- TEVA NEDERLAND 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
Sint Antonius Ziekenhuis Stichting
- Sponsor organisation
- Sint Antonius Ziekenhuis Stichting
- Address
- Koekoekslaan 1
- City
- Nieuwegein
- Postcode
- 3435 CM
- Country
- Netherlands
Scientific contact point
- Organisation
- Sint Antonius Ziekenhuis Stichting
- Contact name
- Ashley Verburg
Public contact point
- Organisation
- Sint Antonius Ziekenhuis Stichting
- Contact name
- Ashley Verburg
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 200 | 1 |
| 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 | 2024-10-15 | 2024-10-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518464-12-00_CLEAN | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Procedure NL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_CLEAN | 1.3 |
| Summary of Product Characteristics (SmPC) (for publication) | G2 SPC Ascal | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2 SPC Clopidogrel | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-518464-12-00_EN | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-518464-12-00_EN_TC | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-518464-12-00_NL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-518464-12-00_NL_TC | 2.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-26 | Netherlands | Acceptable with conditions 2024-10-15
|
2024-10-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-29 | Netherlands | Acceptable 2024-11-26
|
2024-11-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-23 | Netherlands | Acceptable 2026-01-29
|
2026-01-29 |