Clinical trial • Phase IV • Gastroenterology
ACENOCOUMAROL for Colorectal polyps (colorectal lesions requiring polypectomy)|Oral anticoagulant therapy
Phase IV trial of ACENOCOUMAROL for Colorectal polyps (colorectal lesions requiring polypectomy)|Oral anticoagulant therapy. CTIS 2024-512194-27.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Colorectal polyps (colorectal lesions requiring polypectomy)|Oral anticoagulant therapy
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 12-04-2024
- First CTIS Authorization Date
- 18-06-2024
Trial design
Randomised, short-term interruption versus maintenance (continuous) anticoagulation. comparator arm: continuous anticoagulation using the participant's oral anticoagulant (vka: acenocoumarol or warfarin; or doacs: dabigatran, edoxaban, apixaban, rivaroxaban). doses/schedules are not specified in the ctis record.-controlled Phase IV trial across 11 sites in Spain.
- Randomised
- Yes
- Comparator
- Short-term interruption versus maintenance (continuous) anticoagulation. Comparator arm: continuous anticoagulation using the participant's oral anticoagulant (VKA: acenocoumarol or warfarin; or DOACs: dabigatran, edoxaban, apixaban, rivaroxaban). Doses/schedules are not specified in the CTIS record.
- Target Sample Size
- 394
Eligibility
Recruits 394 Vulnerable population not selected. Trial enrols adults only (Age 18 years or older). Informed consent is required from participants; subject information and informed consent forms are provided (documents listed: D1_Protocolo_Anexo 1 - Hoja de informacion y CI; D1_HIP-CI 2024-512194-27-01_V3). No assent/parental consent procedures are indicated..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- Vulnerable population not selected. Trial enrols adults only (Age 18 years or older). Informed consent is required from participants; subject information and informed consent forms are provided (documents listed: D1_Protocolo_Anexo 1 - Hoja de informacion y CI; D1_HIP-CI 2024-512194-27-01_V3). No assent/parental consent procedures are indicated.
Inclusion criteria
- {"criterion_text":"- Age 18 years or older\n- Patients undergoing elective outpatient colonoscopy for any indication\n- Anticoagulant treatment with VKA (acenocoumarol or warfarin) or OACD (dabigatran, edoxaban, apixaban or rivaroxaban) prior to colonoscopy"}
Exclusion criteria
- {"criterion_text":"- Concomitant antiagregant treatment\n- Planned endoscopic dilatation\n- Severe psychiatric disorder\n- Removal of colorectal lesion by endoscopic submucosal dissection\n- Previous diagnosis of renal failure defined as creatinine >2 mg/dl or clearance < 30 ml/min\n- Planned procedure of high haemorrhagic risk in simultaneously performed gastroscopy\n- Prior trial enrolment. Patients may only be included on one occasion\n- Any clinical situation or concomitant treatment that in the investigator's judgement poses a significant bleeding risk\n- Age > 85 years old\n- Urgent colonoscopy\n- Labile INR (time in therapeutic range less than 60%) documented in the previous 3 months in patients receiving VKAs\n- Supra-therapeutic INR (> 3.5) at the time of the procedure in patients receiving VKA\n- Pregnancy\n- Decompensated liver cirrhosis\n- Inability, in the investigator's judgement, to understand the periprocedural anticoagulation regimen\n- Previously known coagulopathy or bleeding diathesis. Includes plateletopenia < 50,000/µL in the previous 12 months"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Occurrence of haemorrhage events post-polypectomy","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Occurrence of thromboembolic events post-polypectomy","definition_or_measurement_approach":""}
- {"endpoint_text":"- Carbon footprint associated with each intervention arm of the clinical trial","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 394
- Recruitment Window Months
- 24
- Consent Approach
- Informed consent obtained from adult participants (≥18 years). Subject information and informed consent forms are provided (documents: D1_Protocolo_Anexo 1 - Hoja de informacion y CI; D1_HIP-CI 2024-512194-27-01_V3). Materials/translations available include Spanish. No procedures for assent or parental consent are indicated.
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 394
Spain
- Earliest CTIS Part Ii Submission Date
- 12-04-2024
- Latest Decision Or Authorization Date
- 30-05-2025
- Processing Time Days
- 413
- Number Of Sites
- 11
- Number Of Participants
- 394
Sites
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Servicio de Gastroenterología y Hepatología
- Principal Investigator Name
- José Santiago García
- Principal Investigator Email
- jose.santiago@salud.madrid.org
- Contact Person Name
- José Santiago García
- Contact Person Email
- jose.santiago@salud.madrid.org
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Servicio de Gastroenterología y Hepatología
- Principal Investigator Name
- Eva Barreiro Alonso
- Principal Investigator Email
- evabarreiroalonso@yahoo.es
- Contact Person Name
- Eva Barreiro Alonso
- Contact Person Email
- evabarreiroalonso@yahoo.es
- Site Name
- Hospital San Agustín de Avilés
- Department Name
- Servicio de Gastroenterología y Hepatología
- Principal Investigator Name
- Daniel Pérez Corte
- Principal Investigator Email
- ddaannii8877@gmail.com
- Contact Person Name
- Daniel Pérez Corte
- Contact Person Email
- ddaannii8877@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Servicio de Gastroenterología
- Principal Investigator Name
- Julia Martínez Ocón
- Principal Investigator Email
- jocon@clinic.cat
- Contact Person Name
- Julia Martínez Ocón
- Contact Person Email
- jocon@clinic.cat
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Servicio Gastroenterología y Hepatología
- Principal Investigator Name
- Enrique Rodríguez de Santiago
- Principal Investigator Email
- enrodesan@gmail.com
- Contact Person Name
- Enrique Rodríguez de Santiago
- Contact Person Email
- enrodesan@gmail.com
- Site Name
- Hospital Universitario De Cabuenes
- Department Name
- Servicio de Aparato Digestivo
- Principal Investigator Name
- Miguel Ángel de Jorge Turrión
- Principal Investigator Email
- mianjortur@hotmail.com
- Contact Person Name
- Miguel Ángel de Jorge Turrión
- Contact Person Email
- mianjortur@hotmail.com
- Site Name
- Hospital Del Mar
- Department Name
- Servicio de Digestología
- Principal Investigator Name
- Fausto Riu Pons
- Principal Investigator Email
- fausto.riu@gmail.com
- Contact Person Name
- Fausto Riu Pons
- Contact Person Email
- fausto.riu@gmail.com
- Site Name
- Hospital Universitario Rio Hortega
- Department Name
- Servicio de Gastroenterología y Hepatología
- Principal Investigator Name
- Henar Núñez Rodríguez
- Principal Investigator Email
- henarnrod@yahoo.es
- Contact Person Name
- Henar Núñez Rodríguez
- Contact Person Email
- henarnrod@yahoo.es
- Site Name
- Hospital Sierrallana
- Department Name
- Servicio de Aparato Digestivo
- Principal Investigator Name
- Carlos Rodríguez Escaja
- Principal Investigator Email
- ruedagotor@gmail.com
- Contact Person Name
- Carlos Rodríguez Escaja
- Contact Person Email
- ruedagotor@gmail.com
- Site Name
- Hospital Universitario Príncipe de Asturias
- Department Name
- Servicio de Aparato Digestivo
- Principal Investigator Name
- Andrés Santos Rodríguez
- Principal Investigator Email
- andres.santos@salud.madrid.org
- Contact Person Name
- Andrés Santos Rodríguez
- Contact Person Email
- andres.santos@salud.madrid.org
- Site Name
- Clínica Rotger Quirónsalud
- Department Name
- Servicio de Aparato Digestivo
- Principal Investigator Name
- Ángel Cañete Ruiz
- Principal Investigator Email
- angel.canete@quironsalud.es
- Contact Person Name
- Ángel Cañete Ruiz
- Contact Person Email
- angel.canete@quironsalud.es
Sponsor
Primary sponsor
- Full Name
- Hospital Universitario Ramon Y Cajal
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- ACENOCOUMAROL
- Active Substance
- ACENOCOUMAROL
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus=2)
- Maximum Dose
- 8 mg
- Investigational Product Name
- EDOXABAN
- Active Substance
- EDOXABAN
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus=2)
- Maximum Dose
- 60 mg
- Investigational Product Name
- WARFARIN SODIUM
- Active Substance
- WARFARIN SODIUM
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus=2)
- Maximum Dose
- 10 mg
- Investigational Product Name
- APIXABAN
- Active Substance
- APIXABAN
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus=2)
- Maximum Dose
- 10 mg
- Investigational Product Name
- RIVAROXABAN
- Active Substance
- RIVAROXABAN
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus=2)
- Maximum Dose
- 30 mg
- Investigational Product Name
- DABIGATRAN ETEXILATE
- Active Substance
- DABIGATRAN ETEXILATE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus=2)
- Maximum Dose
- 300 mg
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