Short-term interruption versus continuous anticoagulation in colorectal polypectomy. A randomized multicenter investigator-initiated non-inferiority clinical trial: the POLYPHEM trial.

2024-512194-27-01 Therapeutic use (Phase IV) Ongoing, recruiting

Start 21 Oct 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 11 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 394
Countries 1
Sites 11

Patients receiving oral anticoagulant therapy who are scheduled for elective colonoscopy for any indication.

To evaluate the safety of maintaining anticoagulationtratment during polypectomy in colorrectal lesions.

Key facts

Sponsor
Hospital Universitario Ramon Y Cajal
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Digestive System Diseases [C06], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
Trial duration
21 Oct 2024 → ongoing
Decision date (initial)
2024-06-18
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
Asociación Española de Gastroenterología · Sociedad Europea de Endoscopia Digestiva · Instituto de Salud Carlos III

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

To evaluate the safety of maintaining anticoagulationtratment during polypectomy in colorrectal lesions.

Secondary objectives 2

  1. Explore whether maintaining anticoagulation during polypectomy reduces the risk of thromboembolic events.
  2. Explore if maintaining anticoagulation reduces the carbon footprint (Kg CO2e)

Conditions and MedDRA coding

Patients receiving oral anticoagulant therapy who are scheduled for elective colonoscopy for any indication.

Regulatory references

Plan to share IPD
No
EU CT numberTitleSponsor
2024-512194-27-00 Short-term interruption versus continuous anticoagulation in colorectal polypectomy. A randomized multicenter investigator-initiated non-inferiority clinical trial: the POLYPHEM trial. Hospital Universitario Ramon Y Cajal

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Age 18 years or older
  2. Patients undergoing elective outpatient colonoscopy for any indication
  3. Anticoagulant treatment with VKA (acenocoumarol or warfarin) or OACD (dabigatran, edoxaban, apixaban or rivaroxaban) prior to colonoscopy

Exclusion criteria 16

  1. Concomitant antiagregant treatment
  2. Age > 85 years old
  3. Urgent colonoscopy
  4. Labile INR (time in therapeutic range less than 60%) documented in the previous 3 months in patients receiving VKAs
  5. Supra-therapeutic INR (> 3.5) at the time of the procedure in patients receiving VKA
  6. Pregnancy
  7. Decompensated liver cirrhosis
  8. Inability, in the investigator's judgement, to understand the periprocedural anticoagulation regimen
  9. Previously known coagulopathy or bleeding diathesis. Includes plateletopenia < 50,000/µL in the previous 12 months
  10. Planned endoscopic dilatation
  11. Severe psychiatric disorder
  12. Removal of colorectal lesion by endoscopic submucosal dissection
  13. Previous diagnosis of renal failure defined as creatinine >2 mg/dl or clearance < 30 ml/min
  14. Planned procedure of high haemorrhagic risk in simultaneously performed gastroscopy
  15. Prior trial enrolment. Patients may only be included on one occasion
  16. Any clinical situation or concomitant treatment that in the investigator's judgement poses a significant bleeding risk

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Occurrence of haemorrhage events post-polypectomy

Secondary endpoints 2

  1. Occurrence of thromboembolic events post-polypectomy
  2. Carbon footprint associated with each intervention arm of the clinical trial

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Edoxaban

SCP257594 · ATC

Active substance
Edoxaban
Route of administration
ORAL
Max daily dose
60 mg milligram(s)
Max total dose
60 mg milligram(s)
Max treatment duration
10000 Week(s)
Authorisation status
Authorised
ATC code
B01AF03 — EDOXABAN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Acenocoumarol

SCP135331 · ATC

Active substance
Acenocoumarol
Substance synonyms
NICOUMALONE, ACENOCUMARIN
Route of administration
ORAL
Max daily dose
8 mg milligram(s)
Max total dose
8 mg milligram(s)
Max treatment duration
10000 Week(s)
Authorisation status
Authorised
ATC code
B01AA07 — ACENOCOUMAROL
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

—

SCP135210 · ATC

Route of administration
ORAL
Max daily dose
300 mg milligram(s)
Max total dose
300 mg milligram(s)
Max treatment duration
10000 Week(s)
Authorisation status
Authorised
ATC code
B01AE07 — DABIGATRAN ETEXILATE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lactose Monohydrate

SCP100377272 · ATC

Active substance
Lactose Monohydrate
Substance synonyms
LACTOSE hydrate
Route of administration
ORAL
Max daily dose
30 mg milligram(s)
Max total dose
30 mg milligram(s)
Max treatment duration
10000 Week(s)
Authorisation status
Authorised
ATC code
B01AF01 — RIVAROXABAN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Warfarin Sodium

SCP133342 · ATC

Active substance
Warfarin Sodium
Substance synonyms
SODIUM 4-OXO-3-(3-OXO-1-PHENYL-BUTYL)CHROMEN-2-OLATE, SODIUM 2-OXO-3-(3-OXO-1-PHENYLBUTYL)CHROMEN-4-OLATE
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
10000 Week(s)
Authorisation status
Authorised
ATC code
B01AA03 — WARFARIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Apixaban

SCP154589 · ATC

Active substance
Apixaban
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
10000 Week(s)
Authorisation status
Authorised
ATC code
B01AF02 — APIXABAN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Universitario Ramon Y Cajal

Sponsor organisation
Hospital Universitario Ramon Y Cajal
Address
Carretera Del Colmenar Viejo Km 9 100, Por El Pardo Por El Pardo
City
Madrid
Postcode
28034
Country
Spain

Scientific contact point

Organisation
Hospital Universitario Ramon Y Cajal
Contact name
Enrique Rodríguez de Santiago

Public contact point

Organisation
Hospital Universitario Ramon Y Cajal
Contact name
Enrique Rodríguez de Santiago

Locations

1 EU/EEA country · 11 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Ongoing, recruiting 394 11
Rest of world — 0 —

Investigational sites

Spain

11 sites · Ongoing, recruiting
Hospital Universitario Puerta De Hierro De Majadahonda
Servicio de Gastroenterología y Hepatología, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Sierrallana
Servicio de Aparato Digestivo, Barrio Ganzo s/n, 39300, Torrelavega
Hospital Universitario De Cabuenes
Servicio de Aparato Digestivo, Calle Prados 395, Cabuenes, Gijon
Hospital Universitario Ramon Y Cajal
Servicio Gastroenterología y Hepatología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital San Agustín de Avilés
Servicio de Gastroenterología y Hepatología, Camino de Heros, 6, Avilés (Asturias)
Hospital Clinic De Barcelona
Servicio de Gastroenterología, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Rio Hortega
Servicio de Gastroenterología y Hepatología, Calle Dulzaina 2, 47012, Valladolid
Hospital Universitario Central De Asturias
Servicio de Gastroenterología y Hepatología, Avenida De Roma S/n, 33011, Oviedo
Hospital Del Mar
Servicio de Digestología, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Príncipe de Asturias
Servicio de Aparato Digestivo, Carretera de Maco SN, Spain
Clínica Rotger Quirónsalud
Servicio de Aparato Digestivo, Via Roma, 3

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Spain 2024-10-21 2024-10-21

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocolo 2024-512194-27 _V05_control de cambios 1
Protocol (for publication) D1_Protocolo 2024-512194-27 _V05_CTIS 1
Protocol (for publication) D1_Protocolo 2024-512194-27-00 1
Protocol (for publication) D1_Protocolo_Anexo 1- Hoja de informacion y CI 1
Protocol (for publication) D1_Protocolo_Anexo 3_1- GR A_Mantiene ACO AVK 1
Protocol (for publication) D1_Protocolo_Anexo 3_2- GR A_Mantiene ACO NACO 1
Protocol (for publication) D1_Protocolo_Anexo 3_3- GR B_Suspende ACO AVK alto riesgo sintrom 1
Protocol (for publication) D1_Protocolo_Anexo 3_4- GR B_Suspende ACO AVK alto riesgo warfa 1
Protocol (for publication) D1_Protocolo_Anexo 3_5- GR B_Suspende ACO AVK bajo riesgo 1
Protocol (for publication) D1_Protocolo_Anexo 3_6- GR B_Suspende ACO NACO 1
Protocol (for publication) D1_Protocolo_Anexo 4- CRD 1
Recruitment arrangements (for publication) K1_Reclutamiento 2024-512194-27-00 1
Subject information and informed consent form (for publication) D1_HIP-CI 2024-512194-27-01_V3 2
Subject information and informed consent form (for publication) D1_Protocolo_Anexo 1- Hoja de informacion y CI 2
Summary of Product Characteristics (SmPC) (for publication) Acenocumarol_ficha tecnica 1
Summary of Product Characteristics (SmPC) (for publication) Apixaban_ficha tecnica 1
Summary of Product Characteristics (SmPC) (for publication) Dabigatran_ficha tecnica 1
Summary of Product Characteristics (SmPC) (for publication) Edoxaban_ficha tecnica 1
Summary of Product Characteristics (SmPC) (for publication) Rivaroxaban_ficha tecnica 1
Summary of Product Characteristics (SmPC) (for publication) Warfarina_ficha tecnica 1
Synopsis of the protocol (for publication) D1_Protocolo_Resumen 1

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-04-12 Spain Acceptable
2024-06-18
 2024-06-18
2 NON SUBSTANTIAL MODIFICATION NSM-1 2024-10-29 Spain Acceptable
2024-06-18
 2024-10-29
3 SUBSTANTIAL MODIFICATION SM-4 2025-04-01 Spain Acceptable
2025-05-30
 2025-05-30
4 SUBSTANTIAL MODIFICATION SM-8 2026-01-23 Spain Acceptable
2026-02-20
 2026-02-23

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