Clinical trial • Phase III • Other

acetylsalicylic acid for Preeclampsia

Phase III trial of acetylsalicylic acid for Preeclampsia.

Overview

Trial Therapeutic Area
Other
Trial Disease
Preeclampsia
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
29-01-2026
First CTIS Authorization Date
07-05-2026

Trial design

Randomised, control: continue aspirin (asa) until 36 weeks. intervention: stop asa between weeks 24 and 26. dose/schedule not specified in ctis record. Phase III trial across 23 sites in Spain.

Randomised
Yes
Comparator
Control: continue aspirin (ASA) until 36 weeks. Intervention: stop ASA between weeks 24 and 26. Dose/schedule not specified in CTIS record.
Target Sample Size
5000

Eligibility

Recruits 5000 Vulnerable population not selected. Participants must be older than 18 years and able to read and understand the informed consent; pregnant women are the target population. Consent is provided by the participant (no assent procedures described)..

Pregnancy Exclusion
Early pregnancy loss, stillbirth or fetus with major malformations
Vulnerable Population
Vulnerable population not selected. Participants must be older than 18 years and able to read and understand the informed consent; pregnant women are the target population. Consent is provided by the participant (no assent procedures described).

Inclusion criteria

  • {"criterion_text":"- Patients older than 18 years\n- Ability to read and understand the informed consent\n- Singleton pregnancy\n- Having undergone first-trimester preeclampsia screening (11+0 to 13+6 weeks) using a multiparametric algorithm and being classified as high risk.\n- 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

  • {"criterion_text":"- Early pregnancy loss, stillbirth or fetus with major malformations\n- Fetus affected by a known genetic or chromosomal disease\n- Contraindication, allergy, or intolerance to aspirin (AAS)\n- Inability to discontinue aspirin (e.g., antiphospholipid syndrome, etc.)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Non-inferiority comparison of incidence of preterm preeclampsia between the arm stopping ASA at 24–26 weeks and the arm continuing ASA until 36 weeks; specific measurement methods/timepoints not specified in the CTIS record."}

Secondary endpoints

  • {"endpoint_text":"- To assess whether ASA discontinuation does not increase maternal, fetal, or neonatal morbidity or mortality.","definition_or_measurement_approach":"Assessment of maternal, fetal, and neonatal morbidity and mortality comparing arms; specific endpoints and measurement approach not specified in the CTIS record."}
  • {"endpoint_text":"- To assess whether ASA discontinuation discontinuing aspirin treatment reduces the risk of maternal hemorrhage","definition_or_measurement_approach":"Assessment of maternal hemorrhage risk comparing arms; specific definitions/measurement approach not specified in the CTIS record."}

Recruitment

Planned Sample Size
5000
Recruitment Window Months
35
Consent Approach
Informed consent is required from participants who must be >18 years and able to read and understand the informed consent. Subject information and informed consent form documents are listed (L1_SIS and ICF General). No assent procedures described; languages available not specified in the CTIS record.

Geography

Total Number Of Sites
23
Total Number Of Participants
11836

Spain

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
38
Number Of Sites
23
Number Of Participants
11836

Sites

Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Agueda Rodriguez Vicente
Principal Investigator Email
Arodriguezv.girona.ics@gencat.cat
Contact Person Name
Agueda Rodriguez Vicente
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Obstetrics and Gynecology
Principal Investigator Name
Raquel Mula Used
Principal Investigator Email
raqmul@dexeus.com
Contact Person Name
Raquel Mula Used
Contact Person Email
raqmul@dexeus.com
Site Name
Hospital De Jerez De La Frontera
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Cristina Romero Garri
Contact Person Name
Cristina Romero Garri
Site Name
Hospital Universitario De Leon
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Camino Fernandez Fernandez
Principal Investigator Email
cfdezfdez@saludcastillayleon.es
Contact Person Name
Camino Fernandez Fernandez
Site Name
Clinica Universidad De Navarra
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Laura Emilia Muñoz Saa
Principal Investigator Email
lmunozs@unav.com
Contact Person Name
Laura Emilia Muñoz Saa
Contact Person Email
lmunozs@unav.com
Site Name
Hospital Universitario De Burgos
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Leire González Mañaricua
Principal Investigator Email
lgonzalezm@saludcastillayleon.es
Contact Person Name
Leire González Mañaricua
Site Name
Hospital Universitario De Cruces
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Elena Gibbone
Principal Investigator Email
elena.gibbone@osakidetza.eus
Contact Person Name
Elena Gibbone
Contact Person Email
elena.gibbone@osakidetza.eus
Site Name
Complejo Hospitalario Universitario Juan Canalejo
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Nuria Valiño Calviño
Principal Investigator Email
Nuria.Valino.Calvino@sergas.es
Contact Person Name
Nuria Valiño Calviño
Contact Person Email
Nuria.Valino.Calvino@sergas.es
Site Name
Hospital Universitario Rey Juan Carlos
Department Name
Obstetrics and Gynecology
Principal Investigator Name
Marina Perez Serrano
Principal Investigator Email
marina.pserrano@hospitalreyjuancarlos.es
Contact Person Name
Marina Perez Serrano
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Ana Maria Palacios Marqués
Principal Investigator Email
ana.palacios.marques@gmail.com
Contact Person Name
Ana Maria Palacios Marqués
Contact Person Email
ana.palacios.marques@gmail.com
Site Name
Fundacio Assistencial De Mutua De Terrassa Fpc
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Eva Lucia Lopez Quesada
Principal Investigator Email
evalopez@mutuaterrassa.es
Contact Person Name
Eva Lucia Lopez Quesada
Contact Person Email
evalopez@mutuaterrassa.es
Site Name
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Ivanna LLordella Sarmiento
Principal Investigator Email
Lsarmiento.lleida.ics@gencat.cat
Contact Person Name
Ivanna LLordella Sarmiento
Site Name
Hospital Universitario De Getafe
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Elena Pintado
Principal Investigator Email
elenapintadoparedes@gmail.com
Contact Person Name
Elena Pintado
Contact Person Email
elenapintadoparedes@gmail.com
Site Name
Consorci Sanitari De Terrassa
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Àngels Vives Argilagós
Principal Investigator Email
MAVives@cst.cat
Contact Person Name
Àngels Vives Argilagós
Contact Person Email
MAVives@cst.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Manel Mendoza Cobaleda
Principal Investigator Email
manel.mendoza@vallhebron.cat
Contact Person Name
Manel Mendoza Cobaleda
Contact Person Email
manel.mendoza@vallhebron.cat
Site Name
Hospital Universitari Joan XXIII De Tarragona
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Monica López Rodriguez
Principal Investigator Email
mlopezrodriguez.hj23.ics@gencat.cat
Contact Person Name
Monica López Rodriguez
Site Name
Hospital Universitario Puerta Del Mar
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
María de los Ángeles Anaya Baz
Principal Investigator Email
angeles.anaya.sspa@juntadeandalucia.es
Contact Person Name
María de los Ángeles Anaya Baz
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Pablo Garcia Manau
Principal Investigator Email
pgarciama@santpau.cat
Contact Person Name
Pablo Garcia Manau
Contact Person Email
pgarciama@santpau.cat
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Elena Benitez-Cano Naranjo
Principal Investigator Email
elena.benitezcano.sspa@juntadeandalicia.es
Contact Person Name
Elena Benitez-Cano Naranjo
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Obstetrics and Gynecology
Principal Investigator Name
María Setefilla López Criado
Principal Investigator Email
mmefilla@gmail.com
Contact Person Name
María Setefilla López Criado
Contact Person Email
mmefilla@gmail.com
Site Name
Hospital Universitario Severo Ochoa
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Laura De Mingo Romanillos
Principal Investigator Email
laura.demingo@salud.madrid.org
Contact Person Name
Laura De Mingo Romanillos
Contact Person Email
laura.demingo@salud.madrid.org
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Obstetrics and Gynecology
Principal Investigator Name
Miguel Alvaro Navidad
Principal Investigator Email
malvaro@quironsalud.es
Contact Person Name
Miguel Alvaro Navidad
Contact Person Email
malvaro@quironsalud.es
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Obstetrician and Gynecologist
Principal Investigator Name
Laura Hernandez Hernandez
Principal Investigator Email
sms_medicinafetalmurcia@carm.es
Contact Person Name
Laura Hernandez Hernandez

Sponsor

Primary sponsor

Full Name
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
ACETYLSALICYLIC ACID
Active Substance
acetylsalicylic acid
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
150 mg per day

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