Clinical trial • Not applicable • Gastroenterology

Dabigatran etexilate for Colorectal polyps

Not applicable trial of Dabigatran etexilate for Colorectal polyps. None/Not specified-controlled. 686 participants.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Colorectal polyps
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
26-04-2024
First CTIS Authorization Date
05-07-2024

Trial design

None/Not specified-controlled Not applicable trial in Spain.

Comparator
None/Not specified
Target Sample Size
686
Trial Duration For Participant
30

Eligibility

Recruits 686 No vulnerable population selected; participants are adults (18-80). Subject information and informed consent form documents are listed in the trial documents, but specific assent/consent handling details are not available in the provided metadata..

Pregnancy Exclusion
Pregnancy or breastfeeding
Vulnerable Population
No vulnerable population selected; participants are adults (18-80). Subject information and informed consent form documents are listed in the trial documents, but specific assent/consent handling details are not available in the provided metadata.

Inclusion criteria

  • {"criterion_text":"- Subjects between 18 and 80 years old for whom a colonoscopy has been requested for any indication\n- Subjects who are under chronic antiplatelet therapy (other than ASA) or anticoagulant treatment."}

Exclusion criteria

  • {"criterion_text":"- Coronary stent implantation in the previous 6 months or double antiplatelet therapy.\n- Severe comorbility (ASA >3)\n- Decompensated liver cirrhosis\n- Express refusal to participate in the study.\n- Cardiovascular or thromboembolic event (ischemic heart disease, cerebrovascular event, venous thromboembolic disease) in the previous 6 months.\n- Combined treatment with anticoagulants and antiplatelets\n- Chronic kidney disease grade 4 or higher, defined as a Creatinine clearance less than 30 ml/min.\n- Pregnancy or breastfeeding\n- Hemodialysis\n- Thrombophilia or known clotting disorders. Thrombopenia < 50000 platelets/mm3.\n- Urgent colonoscopy"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Significant post-polypectomy hemorrhage","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
686
Recruitment Window Months
28
Consent Approach
Informed consent to be obtained using the provided Subject information and informed consent form documents (listed in the trial documents as L1_SIS and ICF ...). Participants are adults (18-80) and therefore consent is provided by the participant. Specific text of consent/assent procedures and available languages are not provided in the metadata, though consent documents in Spanish are listed.

Geography

Total Number Of Sites
16
Total Number Of Participants
686

Spain

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
608
Number Of Sites
16
Number Of Participants
686

Sites

Site Name
Hospital Germans Trias I Pujol
Department Name
Digestive system
Principal Investigator Name
Laura González
Principal Investigator Email
glaug2@gmail.com
Contact Person Name
Laura González
Contact Person Email
glaug2@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Digestive system
Principal Investigator Name
Carlos Guarner
Principal Investigator Email
cguarnera@santpau.cat
Contact Person Name
Carlos Guarner
Contact Person Email
cguarnera@santpau.cat
Site Name
Hospital General Universitario San Jorge
Department Name
Digestive system
Principal Investigator Name
Santos Santolaria
Principal Investigator Email
ssantolariap@gmail.com
Contact Person Name
Santos Santolaria
Contact Person Email
ssantolariap@gmail.com
Site Name
Hospital General Universitario De Elche
Department Name
Digestive system
Principal Investigator Name
Alicia Brotons
Principal Investigator Email
aliciabbrotons@gmail.com
Contact Person Name
Alicia Brotons
Contact Person Email
aliciabbrotons@gmail.com
Site Name
Hospital Unviersitario Miguel Servet
Department Name
Digestive system
Principal Investigator Name
Raquel Vicente
Principal Investigator Email
raquelvicentelidon@gmail.com
Contact Person Name
Raquel Vicente
Contact Person Email
raquelvicentelidon@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Digestive system
Principal Investigator Name
Juan Antonio Serrano
Principal Investigator Email
juanantonio.serrano@salud.madrid.org
Contact Person Name
Juan Antonio Serrano
Site Name
Hospital Obispo Polanco
Department Name
Digestive system
Principal Investigator Name
Inés Ariño
Principal Investigator Email
arino.ines@gmail.com
Contact Person Name
Inés Ariño
Contact Person Email
arino.ines@gmail.com
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Digestive system
Principal Investigator Name
Rodrigo Jover
Principal Investigator Email
rodrigojover@gmail.com
Contact Person Name
Rodrigo Jover
Contact Person Email
rodrigojover@gmail.com
Site Name
Hospital Ernest Lluch
Department Name
Digestive system
Principal Investigator Name
Viviana Laredo
Principal Investigator Email
vlaredodelatorre@gmail.com
Contact Person Name
Viviana Laredo
Contact Person Email
vlaredodelatorre@gmail.com
Site Name
Hospital Santa Bárbara
Department Name
Digestive system
Principal Investigator Name
Celia del Caño
Principal Investigator Email
celiaccerdan@hotmail.com
Contact Person Name
Celia del Caño
Contact Person Email
celiaccerdan@hotmail.com
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Digestive system
Principal Investigator Name
Carlos Sostres
Principal Investigator Email
carlossostres@gmail.com
Contact Person Name
Carlos Sostres
Contact Person Email
carlossostres@gmail.com
Site Name
Hospital Royo Villanova
Department Name
Digestive system
Principal Investigator Name
Patricia Sanz
Principal Investigator Email
patricia.sanz.segura@gmail.com
Contact Person Name
Patricia Sanz
Contact Person Email
patricia.sanz.segura@gmail.com
Site Name
Hospital Comarcal Alcañiz
Department Name
Digestive system
Principal Investigator Name
Marina Solano
Principal Investigator Email
dramarinas@gmail.com
Contact Person Name
Marina Solano
Contact Person Email
dramarinas@gmail.com
Site Name
Hospital Universitario De Cabueñes
Department Name
Digestive system
Principal Investigator Name
Javier Tejedor
Principal Investigator Email
jtejedor1991@gmail.com
Contact Person Name
Javier Tejedor
Contact Person Email
jtejedor1991@gmail.com
Site Name
Hospital Universitario Donostia
Department Name
Digestive system
Principal Investigator Name
Maria Vaamonde
Principal Investigator Email
maria.lorv@gmail.com
Contact Person Name
Maria Vaamonde
Contact Person Email
maria.lorv@gmail.com
Site Name
Hospital Santos Reyes
Department Name
Digestive system
Principal Investigator Name
Luis Hernández
Principal Investigator Email
luishernandezvillalba@gmail.com
Contact Person Name
Luis Hernández

Sponsor

Primary sponsor

Full Name
Fundacion Instituto De Investigacion Sanitaria Aragon
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
DABIGATRAN ETEXILATE
Active Substance
Dabigatran etexilate
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Maximum Dose
300 mg
Investigational Product Name
CLOPIDOGREL
Active Substance
Clopidogrel
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Maximum Dose
75 mg
Investigational Product Name
RIVAROXABAN
Active Substance
Rivaroxaban
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Maximum Dose
20 mg
Investigational Product Name
APIXABAN
Active Substance
Apixaban
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Maximum Dose
10 mg
Investigational Product Name
ACENOCOUMAROL
Active Substance
Acenocoumarol
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Maximum Dose
4 mg
Investigational Product Name
EDOXABAN
Active Substance
Edoxaban
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Maximum Dose
60 mg

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