Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
200
Countries
1
Sites
10
Atrial fibrillation
1. To compare safety and efficacy of early DAPT discontinuation at 30 days postprocedure and continuation of SAPT up until 6-month vs 6 months of postprocedural DAPT (randomized comparison) 2. To compare safety and efficacy of chronic SAPT beyond 6 months postprocedure vs discontinuation of all antiplatelet treatment 6…
Key facts
- Sponsor
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2024-12-16
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516382-37-00
- EudraCT number
- 2017-001826-16
- ClinicalTrials.gov
- NCT03445949
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
1. To compare safety and efficacy of early DAPT discontinuation at 30 days postprocedure and continuation of SAPT up until 6-month vs 6 months of postprocedural DAPT (randomized comparison)
2. To compare safety and efficacy of chronic SAPT beyond 6 months postprocedure vs discontinuation of all antiplatelet treatment 6 months after LAAC (nonrandomized comparison).
Secondary objectives 1
- not applicable
Conditions and MedDRA coding
Atrial fibrillation
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Successful percutaneous left atrial appendage occlusion with Amplatzer or WATCHMAN devices within 37 days prior to randomization 2. Treatment with dual antiplatelet therapy since the procedure (aspirin and clopidogrel) 3. Age >= 18 yrs 4. Participant is willing to comply with all aspects of the protocol including the assigned treatment strategy and follow-up visits 5. The participant is willing to give written informed consent
Exclusion criteria 1
- 1. Any indication to chronic antiplatelet therapy other than atrial fibrillation or left atrial appendage occlusion. 2. Indications to chronic anticoagulation 3. Known allergy to clopidogrel of acetylsalicylic acid 4. Diagnosis of coagulation disorders 5. Peridevice leaks greater than 5mm 6. Thrombus in the left atrium on the qualifying imaging of the left atrium 7. Life expectancy less than the duration of the trial due to noncardiovascular comorbidity 8. Enrollment into a competing trial using a non-approved devices or drugs - currently and up to 3 months prior to enrollment 9. Chronic kidney disease stage IV or V 10. Women who are pregnant or breastfeeding and those women of childbearing potential who do not agree to use at least two contraceptive measures (oral contraception, mechanical contraception, approved contraceptive implants, intrauterine device, tubal ligation). The criterion does not apply to women who have been postmenopausal for at least 2 years prior to study enrollment (defined as at least one year without menstrual periods) or underwent surgical sterilization procedure. All eligible women who are younger than 55 years must have negative pregnancy test within 24 hours prior to randomization.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Primary endpoint: comprising major adverse cardiac and cerebrovascular events defined as: 1. efficacy: MACCE - stroke, TIA, peripheral embolism, nonfatal myocardial infarction, cardiovascular and overall mortality; device related thrombosis; and 2. safety: moderate and severe bleedings (type 2-5 BARC).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB13395MIG · Substance
- Active substance
- Clopidogrel
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 75 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12730MIG · Substance
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 75 mg milligram(s)
- Max treatment duration
- 70 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
- Sponsor organisation
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
- Address
- Alpejska 42
- City
- Warsaw
- Postcode
- 04-628
- Country
- Poland
Scientific contact point
- Organisation
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
- Contact name
- Clinical Research Support Centre Information Desk
Public contact point
- Organisation
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
- Contact name
- Clinical Research Support Centre Information Desk
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Soft Communication Danuta Moreń ORL-000010799
|
Warszawa, Poland | On site monitoring, Other |
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Authorised, recruitment pending | 200 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Oddział Kardiologii Interwencyjnej i Chorób Wewnętrznych, Ulica Szaserow 128, 04-141, Warsaw
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Katedra i Klinika Kardiologii, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca, Alpejska 42, 04-628, Warsaw
Slaskie Centrum Chorob Serca W Zabrzu
I Oddział Kardiologii i Angiologii, Ul. Marii Curie-Sklodowskiej 9, 41-800, Zabrze
Uniwersyteckie Centrum Kliniczne
I KLINIKA KARDIOLOGII, Ul. Debinki 7, 80-211, Gdansk
Szpitale Pomorskie Sp. z o.o.
Oddział Kardiologii i Angiologii Interwencyjnej, Ul. Dr. Alojzego Jagalskiego 10, 84-200, Wejherowo
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Klinika Kardiologii, Ul. Ulica Stefana Banacha 1a, 02-097, Warsaw
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Klinika Elektrokardiologii, Pomorska 251, 92-213, Łódź
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddział Kardiologii, Ul. Dluga 1/2, 61-848, Poznan
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
II Oddział Kardiologii, Ul. Ziolowa 45/47, 40-635, Katowice
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_ 2024-516382-37-00_redacted | 1.4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_placeholder | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_ 2024-516382-37-00 | 1.7 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_SmPC_a_acid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_SmPC_clopidogrel | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_ 2024-516382-37-00_synopsis | 1.4 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Poland | Acceptable 2024-12-11
|
2024-12-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-25 | Poland | Acceptable 2024-12-11
|
2025-04-25 |