Clinical trial • Phase IV • Cardiology

ATENOLOL, CHLORTALIDONE for Spontaneous coronary artery dissection

Phase IV trial of ATENOLOL, CHLORTALIDONE for Spontaneous coronary artery dissection.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Spontaneous coronary artery dissection
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
09-07-2024
First CTIS Authorization Date
16-07-2024

Trial design

Randomised, open-label, randomization (1:1/1:1) using a 2x2 factorial design comparing: (1) prolonged therapy with β-blockers vs no β-blockers; and (2) 1-month single antiplatelet therapy vs 12-month dual antiplatelet therapy. patients receiving dual antiplatelet therapy during the first year will be assigned, after the first year, to aspirin alone or clopidogrel alone indefinitely.-controlled Phase IV trial in Spain.

Randomised
Yes
Open Label
Yes
Comparator
Randomization (1:1/1:1) using a 2x2 factorial design comparing: (1) Prolonged therapy with β-blockers vs No β-blockers; and (2) 1-month single antiplatelet therapy vs 12-month dual antiplatelet therapy. Patients receiving dual antiplatelet therapy during the first year will be assigned, after the first year, to aspirin alone or clopidogrel alone indefinitely.
Target Sample Size
700
Trial Duration For Participant
365

Eligibility

Recruits 700 Vulnerable population selected; consent requirement: "Written informed consent.".

Pregnancy Exclusion
Pregnant or breastfeeding women. Child-bearing age women participating in the study will be advised to use a highly effective contraceptive method considering the high-risk of recurrent SCAD associated with pregnancy.
Vulnerable Population
Vulnerable population selected; consent requirement: "Written informed consent."

Inclusion criteria

  • {"criterion_text":"- Written informed consent.\n- Patients admitted for ACS or any other manifestation of myocardial ischemia.\n- Diagnosis of SCAD on a coronary angiography during index hospitalization."}

Exclusion criteria

  • {"criterion_text":"- Cardiogenic shock or severe hemodynamic instability.\n- Concomitant severe heart disease requiring surgical correction (in <2 years).\n- Any major medical condition seriously limiting life expectancy (<2 years).\n- Pregnant or breastfeeding women. Child-bearing age women participating in the study will be advised to use a highly effective contraceptive method considering the high-risk of recurrent SCAD associated with pregnancy.\n- Participation in another clinical trial."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- A combined clinical endpoint including death, MI, stroke, coronary revascularization, recurrent dissection and hospital admission for ACS or heart failure at 1-year follow-up.","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- a secondary combined clinical endpoint (composite of death, MI, stroke, coronary revascularization, and recurrent dissection, hospital admission for ACS –with dynamic ECG changes- or heart failure or bleeding) will be used to assess the “net clinical benefit” of the antiplatelet strategy.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Bleeding will be also analyzed as a separate safety secondary endpoint. Bleeding will be defined according to BARC definitions.","definition_or_measurement_approach":"Bleeding defined according to BARC definitions."}
  • {"endpoint_text":"- Individual components of the primary endpoint will be assessed as secondary endpoints. Besides, a major predefined secondary combined endpoint will be the composite outcome measure of “hard” clinical events (including death, MI, stroke, recurrent dissection and coronary revascularization) and the combined outcome measure of death and MI alone.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
700
Recruitment Window Months
53
Consent Approach
Written informed consent required. Subject information and informed consent form available (document 'BA-SCAD PIS-ICF'). No further details on assent or language versions provided in the source documents.

Geography

Total Number Of Sites
60
Total Number Of Participants
700

Spain

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
16-07-2024
Processing Time Days
14
Number Of Sites
60
Number Of Participants
700

Sites

Site Name
Hospital Clinico Universitario De Valencia
Department Name
Cardiology
Principal Investigator Name
Juan Sanchis Fores
Principal Investigator Email
sanchis_juafor@gva.es
Contact Person Name
Juan Sanchis Fores
Contact Person Email
sanchis_juafor@gva.es
Site Name
Hospital Universitario Basurto
Department Name
Cardiology
Principal Investigator Name
Abel Andres Morist
Principal Investigator Email
andres.morist@gmail.com
Contact Person Name
Abel Andres Morist
Contact Person Email
andres.morist@gmail.com
Site Name
Hospital Universitario De Cruces
Department Name
Cardiology
Principal Investigator Name
Luis Fernandez Gonzalez
Principal Investigator Email
luisfg82@hotmail.com
Contact Person Name
Luis Fernandez Gonzalez
Contact Person Email
luisfg82@hotmail.com
Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Cardiology
Principal Investigator Name
Victor Agudelo
Principal Investigator Email
vagudelo.girona.ics@gencat.cat
Contact Person Name
Victor Agudelo
Contact Person Email
vagudelo.girona.ics@gencat.cat
Site Name
Hospital Universitario De Jaen
Department Name
Cardiology
Principal Investigator Name
Victor Manuel Aragón Extremera
Principal Investigator Email
vmaragon@gmail.com
Contact Person Name
Victor Manuel Aragón Extremera
Contact Person Email
vmaragon@gmail.com
Site Name
Hospital De Jerez De La Frontera
Department Name
Cardiology
Principal Investigator Name
Javier León
Principal Investigator Email
javierleonjimenez@gmail.com
Contact Person Name
Javier León
Contact Person Email
javierleonjimenez@gmail.com
Site Name
Hospital Universitario Lucus Augusti
Department Name
Cardiology
Principal Investigator Name
Carlos Gonzalez Juanaty
Principal Investigator Email
carlos.gonzalez.juanatey@sergas.es
Contact Person Name
Carlos Gonzalez Juanaty
Site Name
Hospital Universitario San Juan De Alicante
Department Name
Cardiology
Principal Investigator Name
Araceli Frutos
Principal Investigator Email
aracelifrutos61@gmail.com
Contact Person Name
Araceli Frutos
Contact Person Email
aracelifrutos61@gmail.com
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Cardiology
Principal Investigator Name
Maria Teresa Gil Jimenez
Principal Investigator Email
cougj@hotmail.com
Contact Person Name
Maria Teresa Gil Jimenez
Contact Person Email
cougj@hotmail.com
Site Name
Hospital General Universitario De Castellon
Department Name
Cardiology
Principal Investigator Name
David Tejada
Principal Investigator Email
dtejada67@hotmail.com
Contact Person Name
David Tejada
Contact Person Email
dtejada67@hotmail.com
Site Name
Hospital Universitario De Toledo
Department Name
Cardiology
Principal Investigator Name
Tomas Canton
Principal Investigator Email
tomasc@sescam.jccm.es
Contact Person Name
Tomas Canton
Contact Person Email
tomasc@sescam.jccm.es
Site Name
Hospital Universitario De Salamanca
Department Name
Cardiology
Principal Investigator Name
Ignacio Cruz-Gonzalez
Principal Investigator Email
icruz@saludcastillayleon.es
Contact Person Name
Ignacio Cruz-Gonzalez
Contact Person Email
icruz@saludcastillayleon.es
Site Name
Hospital Clinico Universitario De Valladolid
Department Name
Cardiology
Principal Investigator Name
Ignacio Amat Santos
Principal Investigator Email
ijamat@gmail.com
Contact Person Name
Ignacio Amat Santos
Contact Person Email
ijamat@gmail.com
Site Name
Hospital Universitario Central De Asturias
Department Name
Cardiology
Principal Investigator Name
Pablo Avanzas
Principal Investigator Email
avanzas@secardiologia.es
Contact Person Name
Pablo Avanzas
Contact Person Email
avanzas@secardiologia.es
Site Name
Hospital Universitario De Canarias
Department Name
Cardiology
Principal Investigator Name
Francisco Bosa Ojeda
Principal Investigator Email
franbosa@ull.edu.es
Contact Person Name
Francisco Bosa Ojeda
Contact Person Email
franbosa@ull.edu.es
Site Name
Hospital General Universitario De Albacete
Department Name
Cardiology
Principal Investigator Name
Jesus Maria Jimenez Mazuecos
Principal Investigator Email
jimenezmazuecos@hotmail.com
Contact Person Name
Jesus Maria Jimenez Mazuecos
Contact Person Email
jimenezmazuecos@hotmail.com
Site Name
Hospital Universitario Puerta Del Mar
Department Name
Cardiology
Principal Investigator Name
Alejandro Gutierrez Barrios
Principal Investigator Email
aleklos@hotmail.com
Contact Person Name
Alejandro Gutierrez Barrios
Contact Person Email
aleklos@hotmail.com
Site Name
Hospital Universitario De Leon
Department Name
Cardiology
Principal Investigator Name
Armando Perez de Prado
Principal Investigator Email
aperez@secardiologia.es
Contact Person Name
Armando Perez de Prado
Contact Person Email
aperez@secardiologia.es
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Cardiology
Principal Investigator Name
Juan Horacio Alonso Briales
Principal Investigator Email
juanhalonso62@gmail.com
Contact Person Name
Juan Horacio Alonso Briales
Contact Person Email
juanhalonso62@gmail.com
Site Name
Hospital Universitario De Cabuenes
Department Name
Cardiology
Principal Investigator Name
Iñigo Lozano
Principal Investigator Email
inigo.lozano@gmail.com
Contact Person Name
Iñigo Lozano
Contact Person Email
inigo.lozano@gmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Cardiology
Principal Investigator Name
Soledad Ojeda
Principal Investigator Email
soledad.ojeda18@gmail.com
Contact Person Name
Soledad Ojeda
Contact Person Email
soledad.ojeda18@gmail.com
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Cardiology
Principal Investigator Name
Eduardo Molina
Principal Investigator Email
eduardo.molina.sspa@juntadeandalucia.es
Contact Person Name
Eduardo Molina
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
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Cardiology
Principal Investigator Name
Marcelo Fabian Jimenez Kockar
Principal Investigator Email
MJimenezKo@santpau.cat
Contact Person Name
Marcelo Fabian Jimenez Kockar
Contact Person Email
MJimenezKo@santpau.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Cardiology
Principal Investigator Name
Bruno Garcia del Blanco
Principal Investigator Email
brunogb51@gmail.com
Contact Person Name
Bruno Garcia del Blanco
Contact Person Email
brunogb51@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Cardiology
Principal Investigator Name
Xavier Carrillo
Principal Investigator Email
xcarrillosuarez@gmail.com
Contact Person Name
Xavier Carrillo
Contact Person Email
xcarrillosuarez@gmail.com
Site Name
University Hospital Son Espases
Department Name
Cardiology
Principal Investigator Name
Vicente Peral Disdier
Principal Investigator Email
vicente.peral@ssib.es
Contact Person Name
Vicente Peral Disdier
Contact Person Email
vicente.peral@ssib.es
Site Name
Hospital Del Mar
Department Name
Cardiology
Principal Investigator Name
Alicia Calvo
Principal Investigator Email
acalvofernandez@psmar.cat
Contact Person Name
Alicia Calvo
Contact Person Email
acalvofernandez@psmar.cat
Site Name
Hospital Universitario Puerta Del Mar
Department Name
Cardiology
Principal Investigator Name
Alejandro Gutierrez Barrios
Principal Investigator Email
aleklos@hotmail.com
Contact Person Name
Alejandro Gutierrez Barrios
Contact Person Email
aleklos@hotmail.com
Site Name
Hospital Universitario De Leon
Department Name
Cardiology
Principal Investigator Name
Armando Perez de Prado
Principal Investigator Email
aperez@secardiologia.es
Contact Person Name
Armando Perez de Prado
Contact Person Email
aperez@secardiologia.es
Site Name
Hospital Universitario Juan Ramon Jimenez
Department Name
Cardiology
Principal Investigator Name
Santiago Jesús Camacho Freire
Principal Investigator Email
santiagocamachofreire@gmail.com
Contact Person Name
Santiago Jesús Camacho Freire
Site Name
Hospital General Universitario De Ciudad Real
Department Name
Cardiology
Principal Investigator Name
Fernando Lozano Ruiz-Poveda
Principal Investigator Email
flozanor@sescam.jccm.es
Contact Person Name
Fernando Lozano Ruiz-Poveda
Contact Person Email
flozanor@sescam.jccm.es
Site Name
Hospital Universitario De Badajoz
Department Name
Cardiology
Principal Investigator Name
Juan Manuel Nogales Asensio
Principal Investigator Email
juan.nogales@salud-juntaex.es
Contact Person Name
Juan Manuel Nogales Asensio
Contact Person Email
juan.nogales@salud-juntaex.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Cardiology
Principal Investigator Name
Ana Belen Cid
Principal Investigator Email
Ana.Belen.Cid.Alvarez@sergas.es
Contact Person Name
Ana Belen Cid
Site Name
Hospital Clinico San Carlos
Department Name
Cardiology
Principal Investigator Name
Fernando Macaya Ten
Principal Investigator Email
fernando.macaya.ten@gmail.com
Contact Person Name
Fernando Macaya Ten
Contact Person Email
fernando.macaya.ten@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Cardiology
Principal Investigator Name
José Luis Diez Gil
Principal Investigator Email
diez_jlu@gva.es
Contact Person Name
José Luis Diez Gil
Contact Person Email
diez_jlu@gva.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Cardiology
Principal Investigator Name
Arturo Garcia Touchard
Principal Investigator Email
agtouchard@gmail.com
Contact Person Name
Arturo Garcia Touchard
Contact Person Email
agtouchard@gmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Cardiology
Principal Investigator Name
Juan Antonio Franco Peláez
Principal Investigator Email
jafranco@quironsalud.es
Contact Person Name
Juan Antonio Franco Peláez
Contact Person Email
jafranco@quironsalud.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Cardiology
Principal Investigator Name
Maria Teresa Velazquez
Principal Investigator Email
mariateresa.velazquez@salud.madrid.org
Contact Person Name
Maria Teresa Velazquez
Site Name
Hospital Universitario La Paz
Department Name
Cardiology
Principal Investigator Name
Santiago Jimenez Valero
Principal Investigator Email
santiago.jimenez@salud.madrid.org
Contact Person Name
Santiago Jimenez Valero
Site Name
Hospital Universitario De Caceres
Department Name
Cardiology
Principal Investigator Name
Sebastian Alejandro Romani
Principal Investigator Email
Alejandro.romani@salud-juntaex.es
Contact Person Name
Sebastian Alejandro Romani
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Cardiology
Principal Investigator Name
Xacobe Cid
Principal Investigator Email
xacobe.flores.rios@sergas.es
Contact Person Name
Xacobe Cid
Contact Person Email
xacobe.flores.rios@sergas.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Cardiology
Principal Investigator Name
Ricardo Sanz Ruiz
Principal Investigator Email
rsanzruiz@hotmail.com
Contact Person Name
Ricardo Sanz Ruiz
Contact Person Email
rsanzruiz@hotmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Cardiology
Principal Investigator Name
Angel Sanchez Recalde
Principal Investigator Email
recalde@secardiologia.es
Contact Person Name
Angel Sanchez Recalde
Contact Person Email
recalde@secardiologia.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Cardiology
Principal Investigator Name
Cristobal Urbano
Principal Investigator Email
cristobalurbano@gmail.com
Contact Person Name
Cristobal Urbano
Contact Person Email
cristobalurbano@gmail.com
Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
Cardiology
Principal Investigator Name
Pedro Martin Lorenzo
Principal Investigator Email
pemarlor@hotmail.com
Contact Person Name
Pedro Martin Lorenzo
Contact Person Email
pemarlor@hotmail.com
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Cardiology
Principal Investigator Name
Egon Gross
Principal Investigator Email
egongk@gmail.com
Contact Person Name
Egon Gross
Contact Person Email
egongk@gmail.com
Site Name
Hospital Universitario Torrecardenas
Department Name
Cardiology
Principal Investigator Name
Natalia Bolivar Herrera
Principal Investigator Email
esnatati@hotmail.com
Contact Person Name
Natalia Bolivar Herrera
Contact Person Email
esnatati@hotmail.com
Site Name
Hospital Universitario De Torrejon
Department Name
Cardiology
Principal Investigator Name
Eduardo Alegría Barrero
Principal Investigator Email
ealegria@torrejonsalud.com
Contact Person Name
Eduardo Alegría Barrero
Contact Person Email
ealegria@torrejonsalud.com
Site Name
Hospital Alvaro Cunqueiro
Department Name
Cardiology
Principal Investigator Name
Andrés Iñiguez
Principal Investigator Email
andres.iniguez.romo@sergas.es
Contact Person Name
Andrés Iñiguez
Contact Person Email
andres.iniguez.romo@sergas.es
Site Name
Policlinica Gipuzkoa S.A.
Department Name
Cardiology
Principal Investigator Name
Javier Irazusta Cordoba
Principal Investigator Email
firazusta88@gmail.com
Contact Person Name
Javier Irazusta Cordoba
Contact Person Email
firazusta88@gmail.com
Site Name
Hospital Universitari Joan XXIII De Tarragona
Department Name
Cardiology
Principal Investigator Name
Mauricio Torres
Principal Investigator Email
maoto11@gmail.com
Contact Person Name
Mauricio Torres
Contact Person Email
maoto11@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Cardiology
Principal Investigator Name
Jose Francisco Diaz Fernandez
Principal Investigator Email
josef.diaz.sspa@juntadeandalucia.es
Contact Person Name
Jose Francisco Diaz Fernandez
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Cardiology
Principal Investigator Name
Domingo A. Pascual Figal
Principal Investigator Email
dpascual@um.es
Contact Person Name
Domingo A. Pascual Figal
Contact Person Email
dpascual@um.es
Site Name
Hospital Universitario De Navarra
Department Name
Cardiology
Principal Investigator Name
Valeriano Ruiz Quevedo
Principal Investigator Email
valeriano.ruiz.quevedo@navarra.es
Contact Person Name
Valeriano Ruiz Quevedo
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Cardiology
Principal Investigator Name
Jose Ramón Ruiz Arroyo
Principal Investigator Email
jruizarr@gmail.com
Contact Person Name
Jose Ramón Ruiz Arroyo
Contact Person Email
jruizarr@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Cardiology
Principal Investigator Name
Manuel Vizcaino
Principal Investigator Email
maviar65@hotmail.com
Contact Person Name
Manuel Vizcaino
Contact Person Email
maviar65@hotmail.com
Site Name
Hospital Universitario Virgen De La Macarena (duplicate listing)
Department Name
Cardiology
Principal Investigator Name
Manuel Vizcaino
Principal Investigator Email
maviar65@hotmail.com
Contact Person Name
Manuel Vizcaino
Contact Person Email
maviar65@hotmail.com

Sponsor

Primary sponsor

Full Name
Spanish Society Of Cardiology
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
ATENOLOL
Active Substance
ATENOLOL, CHLORTALIDONE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
100 mg
Investigational Product Name
BISOPROLOL
Active Substance
BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
10 mg
Investigational Product Name
METOPROLOL
Active Substance
METOPROLOL SUCCINATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
400 mg
Investigational Product Name
ACETYLSALICYLIC ACID
Active Substance
CARBASALATE CALCIUM
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
300 mg
Investigational Product Name
CARVEDILOL
Active Substance
PERINDOPRIL TERT-BUTYLAMINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
100 mg
Investigational Product Name
PROPRANOLOL
Active Substance
PROPRANOLOL HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
640 mg
Investigational Product Name
PRASUGREL
Active Substance
PRASUGREL HYDROBROMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
60 mg
Investigational Product Name
CLOPIDOGREL
Active Substance
TELMISARTAN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
300 mg
Investigational Product Name
TICAGRELOR
Active Substance
TICAGRELOR
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
180 mg
Combination Treatment
Yes

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