Overview
Sponsor-declared trial summary
Patent foramen ovale or atrial septum defect
The goal of the study is to evaluate hemostasis, such as coagulation activation, thrombin generation and platelet reactivity following catheter-based closure of patent foramen ovale or atrial septal defect. Differences between post-procedural regimen (i.e. DAPT and rivaroxaban) will be assessed in the current pilot stu…
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
- 4 May 2022 → ongoing
- Decision date (initial)
- 2024-08-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517115-70-00
- EudraCT number
- 2021-005788-34
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The goal of the study is to evaluate hemostasis, such as coagulation activation, thrombin generation and platelet reactivity following catheter-based closure of patent foramen ovale or atrial septal defect. Differences between post-procedural regimen (i.e. DAPT and rivaroxaban) will be assessed in the current pilot study.
Conditions and MedDRA coding
Patent foramen ovale or atrial septum defect
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-514194-22-00 | Platelet inhibition versus direct oral anticoagulation in patients undergoing percutaneous closure of patent foramen ovale or atrial septal defect | Sint Antonius Ziekenhuis Stichting |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- The subject is aged 18 years or older - The subject is scheduled for percutaneous closure of a PFO or ASD as indicated by the treating physician - The subject is able to understand and is willing to provide written informed consent to participate in the trial
Exclusion criteria 1
- - Unable or unwilling to return for required follow-up visits - High likelihood of being unavailable for follow-up or psycho-social condition making study participation impractical - Mechanical heart valves or valvular disease requiring surgery or interventional procedure - Ongoing major bleeding or complicated or recent (<72 hours) major surgery - Severe thrombocytopenia (<50.000/ml) - Mitral valve regurgitation grade 3 or more - Aortic valve stenosis (AVA<1.0cm2 or Pmax>50 mmHg) or regurgitation grade 3 or more - Left ventricular ejection fraction <30% - Life expectancy of less than 1 year - Any indication for long-term oral anticoagulation other than presence/closure of a PFO/ASD (such as atrial fibrillation) - Any indication for long-term (dual) antiplatelet therapy other than presence/closure of a PFO/ASD (such as recent coronary stenting) - Contraindication for the use of rivaroxaban or DAPT (e.g. history of intracranial bleeding) in the investigator's opinion - Pregnant or planning to become pregnant during the time of the study - Estimated glomerular filtration rate <50 ml/min/1.73m2 - Use of medication that significantly interacts with rivaroxaban; medication that inhibits cytochrome P450 3A4 or P-glycoprotein (such as ketoconazole, human immunodeficiency virus (HIV) protease inhibitors, clarithromycin, erythromycin and fluconazole) or induces cytochrome P450 3A4 (such as rifampicin and several anti-epileptic drugs).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- This study will capture the following hemostatic endpoints: • Coagulation activation (e.g. prothrombin fragment 1+2, thrombin antithrombin III complex) • Platelet activation (e.g. P-selectin, CD40 ligand) • Von Willebrand Factor Antigen (VWF Ag) • Beta-thrombglobulin (beta-TG) • Plasminogen activator inhibitor-1 (PAI-1) • D-dimer • Thrombin Generation Test • Anti Xa activity
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Xarelto 20 mg film-coated tablets
PRD2976469 · Product
- Active substance
- Rivaroxaban
- Substance synonyms
- BAY59-7939, 5-CHLORO-N-(((5S)-2-OXO-3-(4-(3-OXOMORPHOLIN-4-YL)PHENYL)-1,3-OXAZOLIDIN-5-YL)METHYL)THIOPHENE-2-CARBOXAMIDE, BAY 59-7939, JNJ-39039039
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 660 mg milligram(s)
- Max treatment duration
- 5 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AF01 — -
- Marketing authorisation
- EU/1/08/472/037
- MA holder
- BAYER AG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
Plavix 75 mg film-coated tablets
PRD2912264 · Product
- Active substance
- Clopidogrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 25.50 g gram(s)
- Max treatment duration
- 12 Month(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
SCP12592488 · ATC
- Active substance
- Acetylsalicylic Acid
- Substance synonyms
- ASPIRIN, ACETYLSALICYLIC ACID (ASA), ACIDUM ACETYLSALICYLICUM
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 36500 mg milligram(s)
- Max treatment duration
- 5 Week(s)
- Authorisation status
- Authorised
- ATC code
- N02BA01 — ACETYLSALICYLIC ACID
- Marketing authorisation
- -
- 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
- Errol Aarnink
Public contact point
- Organisation
- Sint Antonius Ziekenhuis Stichting
- Contact name
- Errol Aarnink
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruiting | 52 | 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 | 2022-05-04 |
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 POPular CLOSE redacted | 2.3 |
| Recruitment arrangements (for publication) | Transition study | 1 |
| Subject information and informed consent form (for publication) | SIS and ICF_redacted | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2 SmPC [clopidogrel] | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2 SmPC [rivaroxaban] | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2 SmPC acetylsalicylic acid | 202106 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-08 | Netherlands | Acceptable with conditions 2024-08-15
|
2024-08-15 |