Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Authorised, recruitment pending
Participants planned
16,836
Countries
1
Sites
23
Obstetrics – Preeclampsia
To evaluate whether stopping ASA between weeks 24 and 26 is non-inferior in preventing preterm preeclampsia compared to the control group, which will continue ASA until week 36
Key facts
- Sponsor
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Not possible to specify
- Decision date (initial)
- 2026-05-07
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To evaluate whether stopping ASA between weeks 24 and 26 is non-inferior in preventing preterm preeclampsia compared to the control group, which will continue ASA until week 36
Secondary objectives 2
- To evaluate whether stopping ASA does not increase maternal, fetal, or neonatal morbidity or mortality.
- To evaluate whether stopping ASA reduces the risk of maternal bleeding.
Conditions and MedDRA coding
Obstetrics – Preeclampsia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients older than 18 years
- Ability to read and understand the informed consent
- Singleton pregnancy
- Having undergone first-trimester preeclampsia screening (11+0 to 13+6 weeks) using a multiparametric algorithm and being classified as high risk.
- Voluntary informed consent signature and willing to comply with study protocol (including acceptance of aspirin [ASA] treatment, additional blood tests and ultrasounds, and the assigned treatment duration at randomization).
Exclusion criteria 4
- Early pregnancy loss, stillbirth or fetus with major malformations
- Fetus affected by a known genetic or chromosomal disease
- Contraindication, allergy, or intolerance to aspirin (AAS)
- Inability to discontinue aspirin (e.g., antiphospholipid syndrome, etc.)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To assess whether ASA discontinuation at 24–26 weeks is non-inferior in preventing preterm PE compared with the control group, who will continue ASA until 36 weeks.
Secondary endpoints 2
- To assess whether ASA discontinuation does not increase maternal, fetal, or neonatal morbidity or mortality.
- To assess whether ASA discontinuation discontinuing aspirin treatment reduces the risk of maternal hemorrhage
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB12730MIG · Substance
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 25 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
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Sponsor organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Address
- Passeig De La Vall D'Hebron 119-129
- City
- Barcelona
- Postcode
- 08035
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Contact name
- Manel Mendoza Cobaleda
Public contact point
- Organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Contact name
- Manel Mendoza Cobaleda
Locations
1 EU/EEA country · 23 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 11,836 | 23 |
| Rest of world
Senegal, United Kingdom, Ghana, Gambia
|
— | 5,000 | — |
Investigational sites
Hospital Universitario Fundacion Jimenez Diaz
Obstetrics and Gynecology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Joan XXIII De Tarragona
Obstetrician and Gynecologist, Calle Del Doctor Mallafre Guasch 4, 43005, Tarragona
Consorci Sanitari De Terrassa
Obstetrician and Gynecologist, Carretera De Torrebonica S/N, 08227, Terrassa
Hospital De Jerez De La Frontera
Obstetrician and Gynecologist, Carretera De La Ronda Circunvalacion S/n, 11407, Jerez De La Frontera
Hospital Universitario De Leon
Obstetrician and Gynecologist, Calle Altos De Nava S/n, 24071, Leon
Hospital Universitario Clinico San Cecilio
Obstetrician and Gynecologist, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Fundacio Assistencial De Mutua De Terrassa Fpc
Obstetrician and Gynecologist, Calle De San Antonio No 32, 08221, Terrassa
Hospital Universitario Rey Juan Carlos
Obstetrics and Gynecology, Calle Gladiolo S/n, 28933, Mostoles
Hospital Universitario Puerta Del Mar
Obstetrician and Gynecologist, Avenida De Ana De Viya 21, 11009, Cadiz
Hospital De La Santa Creu I Sant Pau
Obstetrician and Gynecologist, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Complejo Hospitalario Universitario Juan Canalejo
Obstetrician and Gynecologist, Barrio As Xubias 84, 15006, A Coruna
Hospital Universitario De Burgos
Obstetrician and Gynecologist, Avenida De Las Islas Baleares 3, 09006, Burgos
University Clinical Hospital Virgen De La Arrixaca
Obstetrician and Gynecologist, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Hospital Universitario De Cruces
Obstetrician and Gynecologist, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario Virgen De Las Nieves
Obstetrics and Gynecology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Universitari De Girona Doctor Josep Trueta
Obstetrician and Gynecologist, Avinguda De Franca S/n, 17007, Girona
Hospital Universitario Severo Ochoa
Obstetrician and Gynecologist, Avenida Orellana S/n, 28911, Leganes
Hospital Universitari Vall D Hebron
Obstetrician and Gynecologist, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitari Dexeus Grupo Quironsalud
Obstetrics and Gynecology, Calle De Sabino Arana 5-19, 08028, Barcelona
Clinica Universidad De Navarra
Obstetrician and Gynecologist, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital General Universitario Dr. Balmis
Obstetrician and Gynecologist, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Obstetrician and Gynecologist, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Hospital Universitario De Getafe
Obstetrician and Gynecologist, Carretera De Madrid Toledo Km 12,500, 28905, Getafe
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol_ EU CT 2025-524646-94-00 | 1.0 |
| Protocol (for publication) | D1_ Protocol_ EU CT 2025-524646-94-00_CC | 1 |
| Protocol (for publication) | D1_ Protocol_ EU CT 2025-524646-94-00_cc | 1.0 |
| Protocol (for publication) | D1_ Protocol_ EU CT 2025-524646-94-00_clean | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_EU-CT_2025-524646-94-00 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF General | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF General_clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF General_con cambios | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_TROMALYT | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Spanish_EU-CT_2025-524646-94-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Spanish_EU-CT_2025-524646-94-00_cc | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Spanish_EU-CT_2025-524646-94-00_clean | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EU-CT_2025-524646-94-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EU-CT_2025-524646-94-00_cc | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EU-CT_2025-524646-94-00_clean | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-29 | Spain | Acceptable 2026-05-04
|
2026-05-07 |