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Anticoagulated PatientsPhase 4POLYPHEMNCT07185295

Short-term Interruption Versus Continuous Anticoagulation in Colorectal Polypectomy

A Phase 4 study testing To maintain anticoagulant therapy during the polypectomy of colorectal lesions in people with Anticoagulated Patients, run by Outcomes'10 at 10 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is designed to find out if it is safe to keep taking blood-thinning medicine during the removal of polyps from the colon or rectum. It includes patients who regularly take blood thinners and need an elective colonoscopy. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Anticoagulated Patients
What is being tested?
To maintain anticoagulant therapy during the polypectomy of colorectal lesions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
481 participants
Where
10 sitesSpain
Study dates
18 Oct 2024to 30 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age over 18 years.
  • Patients scheduled for elective outpatient colonoscopy for any indication, in whom removal of colorectal polyps will be performed if identified during the procedure.
  • Anticoagulant treatment with vitamin K antagonists (acenocoumarol or warfarin) or direct oral anticoagulants (dabigatran, edoxaban, apixaban, or rivaroxaban) prior to the colonoscopy.

Who cannot join

  • Concomitant antiplatelet therapy.
  • Age over 85 years.
  • Urgent colonoscopy.
  • Labile INR (time in therapeutic range less than 60%) documented in the previous 3 months in patients receiving VKAs.
  • Supratherapeutic INR (>3.5) at the time of the procedure in patients on VKAs.
  • Pregnancy.
Show all 18Show fewer
  • Decompensated liver cirrhosis.
  • Inability, at the investigator's discretion, to understand the periprocedural anticoagulation regimen.
  • Known coagulopathy or bleeding diathesis, including platelet count <50,000/µl in the previous 12 months.
  • Scheduled endoscopic dilation.
  • Severe psychiatric disorder.
  • Removal of colorectal lesions by endoscopic submucosal dissection.
  • Previous diagnosis of renal failure defined as creatinine >2 mg/dl or clearance <30 ml/min.
  • Planned high bleeding risk procedure during simultaneous gastroscopy.
  • Previous inclusion in the trial. Patients may only be included once.
  • Patients who are not candidates for a second endoscopic intervention due to clinical conditions.
  • Any clinical situation or concomitant treatment that, in the investigator's opinion, poses a significant bleeding risk.
  • Patients with polyps larger than 4 cm pending endoscopic resection.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Spain10 sites

  • Servicio de Gastroenterología. Hospital Universitario Príncipe de Asturias. Madrid.

    Alcalá de Henares, Madrid, 28805

  • Servicio de Gastroenterología y Hepatología. Hospital Universitario San Agustín.

    Avilés, Principality of Asturias, 33401

  • Servicio de Digestología, Hospital del Mar. Instituto Hospital del Mar de Investigaciones Médicas.

    Barcelona, Catalonia, 08003

  • Hospital Clinic de Barcelona

    Barcelona, Catalonia, 08036

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid

  • Servicio de Gastroenterología y Hepatología. Unidad de Endoscopias. Hospital Universitario Puerta De Hierro.

    Majadahonda, Madrid, 28222

  • Servicio de Aparato Digestivo. Hospital Universitario de Cabueñes

    Oviedo, Principality of Asturias, 33011

  • Clínica Rotger Quirónsalud

    Palma, Balearic Islands, 07012

  • Servicio de Aparato Digestivo. Hospital Sierrallana. Barrio Ganzo,

    Torrelavega, Cantabria, 39300

  • Servicio de Gastroenterología y Hepatología. Hospital Universitario Río Hortega.

    Valladolid, Castille and León, 47012

Other trials in Spain

About this study

Official title: Short-term Interruption Versus Continuous Anticoagulation in Colorectal Polypectomy, a Randomized Multicenter Investigator-initiated Non-inferiority Clinical Trial

This study is designed to find out if it is safe to keep taking blood-thinning medicine during the removal of polyps from the colon or rectum.

It includes patients who regularly take blood thinners and need an elective colonoscopy.

The main goal is to see how often patients have serious bleeding after the polyp removal within 30 days.

The study is being done in several hospitals, and doctors evaluating the results do not know which treatment patients receive.

Read the detailed description

This multicenter, phase IV, assessor-blinded, non-inferiority clinical trial evaluates the safety of maintaining oral anticoagulant therapy during colorectal polypectomy. The study population includes patients receiving chronic oral anticoagulation treatment with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) who are scheduled for elective colonoscopy for any indication.

The primary objective is to assess the incidence of clinically significant post-polypectomy bleeding within 30 days after the procedure. The trial tests the hypothesis that continuing anticoagulant therapy during polypectomy is non-inferior to interrupting it, with a non-inferiority margin set at 10%.

A total of 481 patients will be enrolled, with 241 patients per group. The intervention consists of maintaining ongoing anticoagulant treatment without modification before the procedure. This trial is classified as a low-intervention study according to regulatory guidelines and aims to provide evidence to optimize the management of anticoagulated patients undergoing colorectal polypectomy.

Being tested
To maintain anticoagulant therapy during the polypectomy of colorectal lesions
Keywords
Anticoagulant therapy, colorectal polypectomy, Oral anticoagulants, colonoscopy, Hemorrhage
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • To maintain anticoagulant therapy during the polypectomy of colorectal lesionsProcedure or surgery

    Group A

Study groups in NCT07185295
Study groupRoleWhat they receive
Maintained Anticoagulant TherapyExperimentalPatients in this treatment group will continue their anticoagulant therapy during the procedure. For those on vitamin K antagonists (VKAs), INR levels will be checked 7-14 days before the endoscopy, and doses adjusted if necessary to maintain therapeutic range (<3.5) before the procedure. Patients on direct oral anticoagulants (DOACs) will skip only the morning dose on the day of the procedure without other changes.
Receives: Procedure: To maintain anticoagulant therapy during the polypectomy of colorectal lesions
Discontinued Anticoagulant TherapyNo interventionIn patients assigned to this treatment arm, anticoagulation will be temporarily discontinued following the recommendations of the 2021 BSG-ESGE clinical practice guideline. The distinction between high and low thrombotic risk will be made according to guidelines.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinically significant intraprocedural bleeding

    Major bleeding during colonoscopy that requires procedure interruption, a drop in hemoglobin >2 g/dL, blood transfusion, interventional radiology, hospitalization, surgery, or results in death.

    The following data will be collected for bleeding events:

    • Date of the event.
    • Length of hospital stay: Quantitative nominal variable. Unit: days.
    • ICU admission: Binary variable (Yes/No).
    • Severity: Assessed according to the ASGE classification.

    Measured: 1 month

  2. Clinically significant delayed hemorrhage

    Gastrointestinal bleeding occurring within 30 days after completion of the colonoscopy that requires an emergency visit, hospitalization, or an intervention.

    Date of the event. - Length of hospital stay: Quantitative nominal variable. Unit: days. - ICU admission: Binary variable (Yes/No). - Severity: Assessed according to the ASGE classification.

    Measured: 1 month

Secondary outcomes (8)

  1. Acute Myocardial Infarction

    A clinical syndrome characterized by evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia.

    Data collected will include event date, hospital stay duration, and ICU stay duration.

    Measured: 1 month

  2. Hospitalization for Unstable Angina

    Unscheduled hospitalization for the treatment of unstable angina occurring within 24 hours from symptom onset. Hospitalization is defined as admission to an inpatient unit or an emergency department visit resulting in a stay of at least 24 hours. Data collected will include event date, hospital stay duration, and ICU stay duration.

    Measured: 1 month

  3. Deep Vein Thrombosis

    Any deep vein thrombosis diagnosed in the upper body (internal jugular, subclavian, axillary/brachial) or lower extremities (iliac, femoral/popliteal, gastrocnemius, peroneal, posterior tibial), or in the inferior vena cava or deep splanchnic veins, as confirmed by ultrasound or contrast imaging techniques including computed tomography (CT), angiography, or magnetic resonance imaging (MRI). Data collected will include event date, hospital stay duration, and ICU stay duration.

    Measured: 1 month

  4. Pulmonary Embolism

    Any pulmonary embolism diagnosed by computed tomography (CT), ventilation-perfusion (V/Q) scan, invasive pulmonary angiography, echocardiography (thrombus visualized in the main pulmonary artery), or confirmed by autopsy. Data collected will include event date, hospital stay duration, and ICU stay duration.

    Measured: 1 month

  5. Stroke, Including Transient Ischemic Attack

    Stroke is defined as an acute episode of focal or global neurological dysfunction caused by a cerebral, spinal, or retinal vascular injury as a result of hemorrhage or infarction.

    Transient ischemic attack (TIA) is defined as a temporary (< 24 hours) episode of focal neurological dysfunction caused by cerebral, spinal, or retinal ischemia without acute infarction. Data collected will include event date, hospital stay duration, and ICU stay duration.

    Measured: 1 month

  6. Peripheral Arterial Embolism or Thrombosis

    Any embolism or arterial thrombosis diagnosed by computed tomography (CT), ultrasound, or magnetic resonance imaging (MRI) involving the splanchnic circulation, upper or lower extremities, or renal arteries. Data collected will include event date, type, hospital stay duration, and ICU stay duration.

    Measured: 1 month

  7. Clinically non-significant intraprocedural bleeding

    Bleeding that persists for more than 1 minute, requires endoscopic treatment, and does not meet the criteria for clinically significant intraprocedural bleeding.

    Measured: 1 month

  8. Death

    It will be recorded as a nominal categorical variable:

    • No/death If death is selected: Cause/unknown cause. It will be also recorded the date of death

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2025
  2. Study start18 Oct 2024
  3. Primary completion18 Nov 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The intervention consists of managing anticoagulation in two different ways during colorectal polypectomy: Comparison of Temporary Interruption of Anticoagulation (Standard of Care) vs. Continuation of Anticoagulation (Interventional Arm)
Masking
Single blind
Who is masked
Investigator
Enrolment
481 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07185295
Sponsor's protocol ID
ECA-HRC-POLYPHEM-04
Acronym
POLYPHEM
Status last verified
Nov 2025
First submitted
5 Sep 2025
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Majano Diaz L, Rodriguez de Santiago E, Nunez Rodriguez H, Corte DP, de Jorge Turrion MA, Pellise M, Ocon JM, Pons FR, Santiago Garcia J, Alonso EB, Escaja CR, Santos Rodriguez A, Canete Ruiz A, Muriel A, Zamora J, Garcia BP, Carbonell SP, Garcia Garcia de Paredes A, Garrido Gomez E, Lopez Cardona J, Duran SL, Aicart-Ramos M, Lalastra CS, Angel Rodriguez Gandia M, Garcia de la Filia I, Aldehuelo RS, Hernandez ET, Martinez Sanchez A, Mateos Munoz B, Martinez Gonzalez J, Ortega JD, de la Fuente Briongos E, Redondo PD, Cano CC, Alvarez LP, Pieter CEC, Remizova MO, Gonzalez Silva I, Ferrer Blanco A, Claros LS, Tejedor-Tejada J, Jimenez Jurado A, Mazzola VKC, Cabal IB, Leoz D, Rivas E, Calvo A, Herreros-de-Tejada A, de Frutos Rosa D, Gomez FV, Gutierrez Landaluce P, Colomet RM, Diez PF, Blanco Garcia L, Castano Fernandez O, Ruiz Zorrilla Lopez R, Lorenzo MEM, Lopez Fernandez E, Sierra Morales M, Garcia Centeno P, Maestro Prada I, Vazquez-Sequeiros E, Albillos Martinez A; Mucosal Resection and Third-Space Endoscopy SEED Working Group. Temporary interruption versus maintenance of anticoagulation in polypectomy of colorectal lesions: study protocol for a multicentre randomised non-inferiority clinical trial POLYPHEM. BMJ Open. 2026 Mar 30;16(3):e111695. doi: 10.1136/bmjopen-2025-111695.

    PubMed 41916623

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing To maintain anticoagulant therapy during the polypectomy of colorectal lesions in people with Anticoagulated Patients, run by Outcomes'10 at 10 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinically significant intraprocedural bleeding (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07185295, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.

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