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Active, Not Recruiting

NCT Number: NCT07185295

Short-term Interruption Versus Continuous Anticoagulation in Colorectal Polypectomy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anticoagulated Patients Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clínica Rotger Quirónsalud, Palma, Balearic Islands, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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.

Treatment and study plan

To maintain anticoagulant therapy during the polypectomy of colorectal lesions

Procedure

Group A

Primary outcomes

  1. Clinically significant intraprocedural bleeding

    Time frame: 1 month

    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.

  2. Clinically significant delayed hemorrhage

    Time frame: 1 month

    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.

Secondary outcomes

  1. Acute Myocardial Infarction

    Time frame: 1 month

    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.

  2. Hospitalization for Unstable Angina

    Time frame: 1 month

    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.

  3. Deep Vein Thrombosis

    Time frame: 1 month

    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.

  4. Pulmonary Embolism

    Time frame: 1 month

    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.

  5. Stroke, Including Transient Ischemic Attack

    Time frame: 1 month

    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.

  6. Peripheral Arterial Embolism or Thrombosis

    Time frame: 1 month

    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.

  7. Clinically non-significant intraprocedural bleeding

    Time frame: 1 month

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

  8. Death

    Time frame: 1 month

    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

Sponsors and collaborators

Lead sponsor

Outcomes'10

Network

Registry information

Official study title

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

Acronym: POLYPHEM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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