Clinical trial • Not applicable • Cardiology

ticagrelor for Severe Symptomatic Aortic Stenosis

Not applicable trial of ticagrelor for Severe Symptomatic Aortic Stenosis.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Severe Symptomatic Aortic Stenosis
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
21-12-2023
First CTIS Authorization Date
16-01-2024

Trial design

Randomised, test arm: brilique (ticagrelor) 60 mg film-coated tablets (oral; product file indicates max daily dose amount 120 mg). comparator arm: adiro 100 mg (acetylsalicylic acid) gastro-resistant tablets (oral; product file indicates max daily dose amount 100 mg). exact on-trial dosing schedule not explicitly stated in the provided record.-controlled Not applicable trial across 32 sites in Spain, Italy, Portugal.

Randomised
Yes
Comparator
Test arm: Brilique (ticagrelor) 60 mg film-coated tablets (oral; product file indicates max daily dose amount 120 mg). Comparator arm: Adiro 100 mg (acetylsalicylic acid) gastro-resistant tablets (oral; product file indicates max daily dose amount 100 mg). Exact on-trial dosing schedule not explicitly stated in the provided record.
Target Sample Size
1200
Trial Duration For Participant
365

Eligibility

Recruits 1200 No vulnerable populations selected. Trial enrols adult patients (>18 years) only; requirement: provision of informed consent prior to any study-specific procedures. No assent procedures for minors are described and minors are excluded..

Pregnancy Exclusion
For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at screening & eligibility visit by one of the following: (a) Postmenopausal, defined as amenorrhea for ≥ 12 months following cessation of all exogenous hormonal treatments, and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range. (b) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered a irreversible surgical sterilization
Vulnerable Population
No vulnerable populations selected. Trial enrols adult patients (>18 years) only; requirement: provision of informed consent prior to any study-specific procedures. No assent procedures for minors are described and minors are excluded.

Inclusion criteria

  • {"criterion_text":"- Provision of informed consent prior to any study specific procedures\n- Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial.\n- Patients with degenerative symptomatic severe AS accepted for TAVI with any of the commercial approved TAVI devices after evaluation of the Heart Team of each center, and with at least one of the following comorbidities: Diabetes Mellitus, the current WHO diagnostic criteria for diabetes should be maintained – fasting plasma glucose ≥ 7.0mmol/l (126mg/dl) or 2–h plasma glucose ≥ 11.1mmol/l (200mg/dl), or under treatment with an oral hypoglycemic or insulin  Prior coronary artery disease (STEMI, NSTEMI, stable angina, or others) documented by invasive or non-invasive ischemia screening tests or imaging study  Prior peripheral arterial disease documented by invasive or non-invasive ischemia screening tests or imaging study\n- Successful TAVI performed by any vascular access.\n- Patients who are not participating in any other clinical trial or research study (registries allowed)."}

Exclusion criteria

  • {"criterion_text":"- Patients under chronic oral anticoagulation for any specific pathology\n- Patients that cannot undergo a regimen of single antiplatelet therapy after TAVI\n- History of overt major bleeding or intracranial hemorrhage\n- Active pathological bleeding\n- History of ischemic stroke within the last 30 days prior TAVI\n- Patients with documented severe hepatic insufficiency\n- For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at screening & eligibility visit by one of the following: (a) Postmenopausal, defined as amenorrhea for ≥ 12 months following cessation of all exogenous hormonal treatments, and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range. (b) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered a irreversible surgical sterilization\n- Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the study. Section 13.1 Ticagrelor Overdose: any dose over the clinically intended dose.\n- Patients randomized in another clinical trial with an investigational product or device over the past 30 days\n- Patients who cannot attend follow-up visits scheduled in the study.\n- History of allergic reactions or intolerance to Ticagrelor or Aspirin or any of the excipients."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- All-cause mortality at 12 months after TAVI\n- Transient ischemic attack (TIA) or stroke at 12 months after TAVI\n- Myocardial infarction at 12 months after TAVI\n- Bleeding at 12 months after TAVI according BARC\n- Net Adverse Clinical Event(s)","definition_or_measurement_approach":"- All-cause mortality: assessed at 12 months after TAVI (vital status at 12 months).\n- TIA or stroke: assessed at 12 months after TAVI (clinical diagnosis/events collected up to 12 months).\n- Myocardial infarction: assessed at 12 months after TAVI (events collected up to 12 months using standard clinical definitions).\n- Bleeding: assessed at 12 months after TAVI according to BARC (Bleeding Academic Research Consortium) definitions.\n- Net Adverse Clinical Event(s): composite endpoint assessed at 12 months (NACE defined in main objective as composite of all-cause mortality, TIA/stroke, myocardial infarction, progressive angina leading to emergency evaluation/rehospitalization/new coronary angiography, valve thrombosis, claudication, acute limb ischemia leading to hospitalization, and any bleeding)."}

Secondary endpoints

  • {"endpoint_text":"- All major bleeding (type 2, 3 and 5) at 12 months after TAVI according BARC\n- Incidence of subclinical valve thrombosis (SVT) detected by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM) at 3 and 12 months after TAVI assessed by 4-dimensional computed tomography (4DCT) imaging (performed only in pre-specified centers)\n- Gender\n- Age\n- Valve type\n- Comorbilities\n- All-caused mortality at 12 months after TAVI\n- Stroke/TIA at 12 months after TAVI\n- Myocardial infarction at 12 months after TAVI\n- Progressive angina leading to emergency evaluation, rehospitalization or new coronary angiography at 12 months after TAVI\n- Thrombotic and bleeding risk score","definition_or_measurement_approach":"- All major bleeding: type 2, 3 and 5 at 12 months assessed using BARC definitions.\n- SVT (HALT/RLM): assessed at 3 and 12 months by 4D-CT imaging in pre-specified centers (detection of hypoattenuated leaflet thickening and reduced leaflet motion).\n- Gender: subgroup variable (recorded at baseline).\n- Age: subgroup/descriptor (recorded at baseline).\n- Valve type: subgroup/descriptor (recorded at baseline).\n- Comorbidities: subgroup analyses (recorded at baseline).\n- All-caused mortality at 12 months: as above (vital status).\n- Stroke/TIA at 12 months: as above (clinical events up to 12 months).\n- Myocardial infarction at 12 months: as above (clinical events up to 12 months).\n- Progressive angina leading to emergency evaluation/rehospitalization/new coronary angiography at 12 months: event captured by clinical follow-up.\n- Thrombotic and bleeding risk score: development/assessment of a risk score for TAVI patients (methodology to be defined in statistical analysis plan)."}

Recruitment

Planned Sample Size
1200
Recruitment Window Months
30
Consent Approach
Informed consent required: 'Provision of informed consent prior to any study specific procedures'. Participants must be adults (>18 years) able to understand and accept participation. Subject information and informed consent form documents are available (country-specific ICFs present for Italy and Portugal and a general L1 ICF). No assent procedures for minors are described; minors are excluded.

Geography

Total Number Of Sites
32
Total Number Of Participants
1200

Spain

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
19-05-2025
Processing Time Days
490
Number Of Sites
23
Number Of Participants
800

Sites

Site Name
Hospital Universitario De Torrejon
Department Name
Cardiology
Principal Investigator Name
Ivan Nuñez Gil
Principal Investigator Email
ibnsky@yahoo.es
Contact Person Name
Ivan Nuñez Gil
Contact Person Email
ibnsky@yahoo.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Cardiology
Principal Investigator Name
Mª Luisa Salido Tahoces
Principal Investigator Email
luisasalido@gmail.com
Contact Person Name
Mª Luisa Salido Tahoces
Contact Person Email
luisasalido@gmail.com
Site Name
Hospital Del Mar
Department Name
Cardiology
Principal Investigator Name
Beatriz Vaquerizo Montilla
Principal Investigator Email
beavaquerizo@yahoo.es
Contact Person Name
Beatriz Vaquerizo Montilla
Contact Person Email
beavaquerizo@yahoo.es
Site Name
Hospital General Universitario De Valencia
Department Name
Cardiology
Principal Investigator Name
Alberto Berenguer
Principal Investigator Email
berenguer_alb@gva.es
Contact Person Name
Alberto Berenguer
Contact Person Email
berenguer_alb@gva.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Cardiology
Principal Investigator Name
Iván Gómez
Principal Investigator Email
ivantomas.gomez@salud.madrid.org
Contact Person Name
Iván Gómez
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Cardiology
Principal Investigator Name
Xacobe Flores
Principal Investigator Email
xacobe.flores.rios@sergas.es
Contact Person Name
Xacobe Flores
Contact Person Email
xacobe.flores.rios@sergas.es
Site Name
Hospital Clinico Universitario De Valladolid
Department Name
Cardiology
Principal Investigator Name
Ignacio Jesús Amat
Principal Investigator Email
ijamat@gmail.com
Contact Person Name
Ignacio Jesús Amat
Contact Person Email
ijamat@gmail.com
Site Name
Hospital General Universitario De Albacete
Department Name
Cardiology
Principal Investigator Name
Jesús Jiménez
Principal Investigator Email
jimenezmazuecos@hotmail.com
Contact Person Name
Jesús Jiménez
Contact Person Email
jimenezmazuecos@hotmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Cardiology
Principal Investigator Name
Jean Paul Vilchez
Principal Investigator Email
jeanpaul_vilchez@iislafe.es
Contact Person Name
Jean Paul Vilchez
Contact Person Email
jeanpaul_vilchez@iislafe.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Cardiology
Principal Investigator Name
Diego López
Principal Investigator Email
diego.lopez.otero@sergas.es
Contact Person Name
Diego López
Contact Person Email
diego.lopez.otero@sergas.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Cardiology
Principal Investigator Name
José Francisco Díaz
Principal Investigator Email
jfdiazf@yahoo.es
Contact Person Name
Alberto Berenguer
Contact Person Email
jfdiazf@yahoo.es
Site Name
Hospital Universitario Puerta Del Mar
Department Name
Cardiology
Principal Investigator Name
Livia Gheorghe
Principal Investigator Email
livia_gheorghe_ro@yahoo.es
Contact Person Name
Livia Gheorghe
Contact Person Email
livia_gheorghe_ro@yahoo.es
Site Name
Hospital Universitario De La Princesa
Department Name
Cardiology
Principal Investigator Name
Fernando Alfonso Manterola
Principal Investigator Email
falf@hotmail.com
Contact Person Name
Fernando Alfonso Manterola
Contact Person Email
falf@hotmail.com
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Cardiology
Principal Investigator Name
Juan Miguel Ruiz
Principal Investigator Email
ruiz_jmi@gva.es
Contact Person Name
Juan Miguel Ruiz
Contact Person Email
ruiz_jmi@gva.es
Site Name
Hospital Clinic De Barcelona
Department Name
Cardiology
Principal Investigator Name
Manel Sabaté
Principal Investigator Email
masabate@clinic.cat
Contact Person Name
Manel Sabaté
Contact Person Email
masabate@clinic.cat
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Cardiology
Principal Investigator Name
Lluís Asmarats
Principal Investigator Email
lasmarats@santpau.cat
Contact Person Name
Lluís Asmarats
Contact Person Email
lasmarats@santpau.cat
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Cardiology
Principal Investigator Name
Antonio Tello
Principal Investigator Email
atellomont@hotmail.com
Contact Person Name
Antonio Tello
Contact Person Email
atellomont@hotmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Cardiology
Principal Investigator Name
Antonio Jesús Muñoz
Principal Investigator Email
ajmunozgarcia@secardiologia.es
Contact Person Name
Antonio Jesús Muñoz
Contact Person Email
ajmunozgarcia@secardiologia.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Cardiology
Principal Investigator Name
Juan Francisco Oteo
Principal Investigator Email
jf.oteo@gmail.com
Contact Person Name
Juan Francisco Oteo
Contact Person Email
jf.oteo@gmail.com
Site Name
Hospital Clinico San Carlos
Department Name
Cardiology
Principal Investigator Name
Luis Nombela
Principal Investigator Email
luis.nombela@salud.madrid.org
Contact Person Name
Luis Nombela
Contact Person Email
luis.nombela@salud.madrid.org
Site Name
Hospital Germans Trias I Pujol
Department Name
Cardiology
Principal Investigator Name
Victoria Vilalta
Principal Investigator Email
victoria.vilalta@gmail.com
Contact Person Name
Victoria Vilalta
Contact Person Email
victoria.vilalta@gmail.com
Site Name
Hospital Alvaro Cunqueiro
Department Name
Cardiology
Principal Investigator Name
Andrés Íñiguez
Principal Investigator Email
andres.iniguez.romo@sergas.es
Contact Person Name
Andrés Íñiguez
Contact Person Email
andres.iniguez.romo@sergas.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Cardiology
Principal Investigator Name
José María de la Torre
Principal Investigator Email
josemariadela.torre@scsalud.es
Contact Person Name
José María de la Torre
Contact Person Email
josemariadela.torre@scsalud.es

Italy

Earliest CTIS Part Ii Submission Date
09-08-2024
Latest Decision Or Authorization Date
16-09-2025
Processing Time Days
403
Number Of Sites
3
Number Of Participants
200

Sites

Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Cardiology
Principal Investigator Name
Giuliano Costa
Principal Investigator Email
giuliano.costa.omnw@pec.omceosr.it
Contact Person Name
Giuliano Costa
Site Name
Azienda Ospediera Universitaria Integrata Verona
Department Name
Cardiology
Principal Investigator Name
Gabriele Pesarini
Principal Investigator Email
Gabriele.pesarini@aovr.veneto.it
Contact Person Name
Gabriele Pesarini
Site Name
Policlinico San Donato S.p.A.
Department Name
Cardiology
Principal Investigator Name
Luca Testa
Principal Investigator Email
luctes@gmail.com
Contact Person Name
Luca Testa
Contact Person Email
luctes@gmail.com

Portugal

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
628
Number Of Sites
6
Number Of Participants
200

Sites

Site Name
Unidade Local De Saude Do Alentejo Central E.P.E.
Department Name
Cardiology
Principal Investigator Name
David Cintra Henriques Silva Neves
Principal Investigator Email
dneves@hevora.min-saude.pt
Contact Person Name
David Cintra Henriques Silva Neves
Contact Person Email
dneves@hevora.min-saude.pt
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Cardiology
Principal Investigator Name
Inês Gonçalves Rodrigues
Principal Investigator Email
ines.rodrigues2@chlc.min-saude.pt
Contact Person Name
Inês Gonçalves Rodrigues
Site Name
University Of Porto
Department Name
Cardiology
Principal Investigator Name
Marta Tavares-Silva
Principal Investigator Email
martartsilva@gmail.com
Contact Person Name
Marta Tavares-Silva
Contact Person Email
martartsilva@gmail.com
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Cardiology
Principal Investigator Name
João Miguel da Silva Marques
Principal Investigator Email
joao.marques@ulssm.min-saude.pt
Contact Person Name
João Miguel da Silva Marques
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Cardiology
Principal Investigator Name
Elisabete Sofia Azenha Balhau Jorge
Principal Investigator Email
elisabetejorge@gmail.com
Contact Person Name
Elisabete Sofia Azenha Balhau Jorge
Contact Person Email
elisabetejorge@gmail.com
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Cardiology
Principal Investigator Name
Pedro Braga
Principal Investigator Email
02316@ulsge.min-saude.pt
Contact Person Name
Pedro Braga
Contact Person Email
02316@ulsge.min-saude.pt

Sponsor

Primary sponsor

Full Name
Fundacion Biomedica Galicia Sur
Organisation Type
Patient organisation/association
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Brilique 60 mg film-coated tablets
Active Substance
ticagrelor
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
120 mg
Investigational Product Name
Adiro 100 mg comprimidos gastrorresistentes EFG
Active Substance
acetylsalicylic acid
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
100 mg

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