Continuing Anticoagulants and Antiplatelets in Cold snare Polypectomy.

2024-511265-11-01 Protocol ICI22/00054 Therapeutic use (Phase IV) Ongoing, recruiting

Start 19 Nov 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 16 sites · Protocol ICI22/00054

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 686
Countries 1
Sites 16

patients who are requested a colonoscopy for any indication and are under antiplatelet treatment (except ASA) or anticoagulant treatment

To demonstrate that the risk of postpolypectomy hemorrhage (immediate relevant or delayed) of non-pedunculated polyps smaller than 10mm removed with a cold snare, in patients under antiplatelet or anticoagulant treatment, is not higher than that of the control group from which said treatment will have been withdrawn ac…

Key facts

Sponsor
Fundacion Instituto De Investigacion Sanitaria Aragon
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Digestive System Diseases [C06]
Trial duration
19 Nov 2024 → ongoing
Decision date (initial)
2024-07-05
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To demonstrate that the risk of postpolypectomy hemorrhage (immediate relevant or delayed) of non-pedunculated polyps smaller than 10mm removed with a cold snare, in patients under antiplatelet or anticoagulant treatment, is not higher than that of the control group from which said treatment will have been withdrawn according to the guidelines of current clinical practice

Secondary objectives 2

  1. To evaluate the risk of postpolypectomy hemorrhage (immediate or delayed) for each drug analyzed, making comparisons between drugs and strategies.
  2. To evaluate the risk of cardiovascular and thrombotic events associated with the withdrawal of these drugs, comparing the incidence of events 30 days after colonoscopy in both groups. It will be analyzed whether maintaining the drug during polypectomy is associated with a reduction in these events.

Conditions and MedDRA coding

patients who are requested a colonoscopy for any indication and are under antiplatelet treatment (except ASA) or anticoagulant treatment

Regulatory references

Plan to share IPD
No
EU CT numberTitleSponsor
2024-511265-11-00 Withdraw or maintain antiplatelets and anticoagulants prior to performing cold snare polypectomy of subcentimeter non-pedunculated colorectal polyps: haemorrhagic and thrombotic risks. Fundacion Instituto De Investigacion Sanitaria Aragon

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. Subjects between 18 and 80 years old for whom a colonoscopy has been requested for any indication
  2. Subjects who are under chronic antiplatelet therapy (other than ASA) or anticoagulant treatment.

Exclusion criteria 11

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Significant post-polypectomy hemorrhage

Investigational products

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

Test 6

Telmisartan

SCP1108233 · ATC

Active substance
Telmisartan
Route of administration
ORAL
Max daily dose
75 mg milligram(s)
Max total dose
4200 mg milligram(s)
Max treatment duration
8 Week(s)
Authorisation status
Authorised
ATC code
B01AC04 — CLOPIDOGREL
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
16800 mg milligram(s)
Max treatment duration
8 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
20 mg milligram(s)
Max total dose
1120 mg milligram(s)
Max treatment duration
8 Week(s)
Authorisation status
Authorised
ATC code
B01AF01 — RIVAROXABAN
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
560 mg milligram(s)
Max treatment duration
8 Week(s)
Authorisation status
Authorised
ATC code
B01AF02 — APIXABAN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Edoxaban

SCP257594 · ATC

Active substance
Edoxaban
Route of administration
ORAL
Max daily dose
60 mg milligram(s)
Max total dose
3360 mg milligram(s)
Max treatment duration
8 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
4 mg milligram(s)
Max total dose
224 mg milligram(s)
Max treatment duration
8 Week(s)
Authorisation status
Authorised
ATC code
B01AA07 — ACENOCOUMAROL
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Instituto De Investigacion Sanitaria Aragon

4 Total trials 3 Recruiting
Academic / Non-commercial
Sponsor organisation
Fundacion Instituto De Investigacion Sanitaria Aragon
Address
Edificio Ciba, Avenida De San Juan Bosco 13 Avenida De San Juan Bosco 13
City
Zaragoza
Postcode
50009
Country
Spain

Scientific contact point

Organisation
Fundacion Instituto De Investigacion Sanitaria Aragon
Contact name
Clinical Investigation Unit

Public contact point

Organisation
Fundacion Instituto De Investigacion Sanitaria Aragon
Contact name
Clinical Investigation Unit

Locations

1 EU/EEA country · 16 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Ongoing, recruiting 686 16
Rest of world — 0 —

Investigational sites

Spain

16 sites · Ongoing, recruiting
Hospital Comarcal Alcañiz
Digestive system, Calle Doctor Repollés, 2, Alcañiz
Hospital Clinico Universitario Lozano Blesa
Digestive system, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Unviersitario Miguel Servet
Digestive system, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Ernest Lluch
Digestive system, Carretera Sagunto-Burgos, Km 254, Calatayud
Hospital Santos Reyes
Digestive system, Avenida Ruperta Baraya, 6, Aranda de Duero
Hospital Universitario 12 De Octubre
Digestive system, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Royo Villanova
Digestive system, Avenida San Gregorio, 50015, Zaragoza
Hospital De La Santa Creu I Sant Pau
Digestive system, Carrer De San Quinti 89, 08041, Barcelona
Hospital General Universitario San Jorge
Digestive system, Avenida de Martínez de Velasco, 36, Huesca
Hospital Universitario Donostia
Digestive system, Pasealeku Doct. Begiristain 109, 20014, Donostia
Hospital General Universitario De Elche
Digestive system, Edificio 2, Camino De La Almazara 11, Elche
Hospital Germans Trias I Pujol
Digestive system, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario De Cabueñes
Digestive system, Calle Los Prados 395, 33203, Gijón
Hospital Obispo Polanco
Digestive system, Avenida De Ruiz Jarabo S/n, 44002, Teruel
Hospital Santa Bárbara
Digestive system, Paseo de Santa Bárbara, s/n, Soria
Hospital General Universitario Dr. Balmis
Digestive system, Avinguda Del Pintor Baeza 12, 03010, Alicante

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 2024-11-19 2024-11-28

Results and documents

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

Documents 20 files

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

TypeTitleVersion
Protocol (for publication) D1_Protocol 2024-511265-11_es 1
Protocol (for publication) D1_Protocol 2024-511265-11-01_es_ 4
Protocol (for publication) D1_Protocol 2024-511265-11-01_es_tc 4
Recruitment arrangements (for publication) K1_Recruitment arrangement_2024_511265_11 1
Recruitment arrangements (for publication) K1_Recruitment arrangement_2024_511265_11-01_es 1
Recruitment arrangements (for publication) K1_Recruitment arrangement_2024_511265_11-01_es_tc 1
Subject information and informed consent form (for publication) Blank document 1
Subject information and informed consent form (for publication) L1_SIS and ICF_2024-511265-11-01_es 3
Subject information and informed consent form (for publication) L1_SIS and ICF_2024-511265-11-01_es_tc 3
Subject information and informed consent form (for publication) L2_Treatment_guideline_es 2
Subject information and informed consent form (for publication) L2_Treatment_guideline_tc_es_ 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Acenocumarol 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Apixaban 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Clopidogrel 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Dabigatran etoxilato 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Edoxaban tosilato 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Rivaroxaban 1
Synopsis of the protocol (for publication) D1_Protocol synopsis 2024-511265-11_es 1
Synopsis of the protocol (for publication) D1_Protocol synopsis 2024-511265-11-01_es_ 2
Synopsis of the protocol (for publication) D1_Protocol synopsis 2024-511265-11-01_es_tc 2

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-04-26 Spain Acceptable
2024-07-05
 2024-07-05
2 SUBSTANTIAL MODIFICATION SM-1 2025-02-27 Spain Acceptable
2025-05-05
 2025-05-07
3 SUBSTANTIAL MODIFICATION SM-2 2025-12-23 Spain Acceptable
2026-02-23
 2026-03-02

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