NCT03669068

Brief Summary

This observational study evaluates the safety of gastrointestinal endoscopy in patients on oral anticoagulants (Vitamin K antagonists, rivaroxaban, dabigatran, edoxaban, and apixaban). This registry aims to assess the incidence, characteristics and risk factors for cardiovascular and bleeding events associated with an endoscopic procedure. Besides, it aims to evaluate the differences between Vitamin K antagonists and DOACs users and to estimate the impact of anticoagulation withdrawal time on the primary and secondary outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,602

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

2.2 years

First QC Date

September 8, 2018

Last Update Submit

July 29, 2020

Conditions

Gastrointestinal BleedingCardiovascular ComplicationAnticoagulants; Circulating, Hemorrhagic DisorderGastrointestinal Endoscopy

Keywords

Gastrointestinal endoscopyOral anticoagulantsGastrointestinal bleedingCardiovascular event

Outcome Measures

Primary Outcomes (1)

  • Incidence of Cardiovascular events

    Nº of patients during the study period presenting with a cardiovascular event, defined as any of the following entities: pulmonary thromboembolism, venous thromboembolism, acute coronary syndrome, arterial peripheral embolism or cerebrovascular accident.

    3 months

Secondary Outcomes (1)

  • Incidence of therapeutic endoscopy-related gastrointestinal bleeding

    3 months

Study Arms (2)

Elective endoscopy

Patients undergoing gastrointestinal endoscopy unrelated to anticoagulant-induced gastrointestinal bleeding.

Procedure: Gastrointestinal endoscopy

Gastrointestinal bleeding

Patients with anticoagulant-induced gastrointestinal bleeding will be analyzed separately

Procedure: Gastrointestinal endoscopy

Interventions

Gastrointestinal endoscopyPROCEDURE

Two separated groups will be included in the registry: 1. Patients with oral anticoagulants-induced gastrointestinal bleeding unrelated to an endoscopic procedure. 2. Patients undergoing elective gastrointestinal endoscopy.

Elective endoscopyGastrointestinal bleeding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients on oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatran)

You may qualify if:

  • Age \>= 18 years.
  • Patients with preoperative use of oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatrán) undergoing gastrointestinal endoscopy.
  • Patients on oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatran) presenting with gastrointestinal bleeding, regardless of receiving gastrointestinal endoscopy.
  • Signed informed consent.

You may not qualify if:

  • Negative to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Gastrointestinal HemorrhageHemorrhagic Disorders

Interventions

Endoscopy, Gastrointestinal

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator. MSc. Gastroenterologist

Study Record Dates

First Submitted

September 8, 2018

First Posted

September 13, 2018

Study Start

January 1, 2018

Primary Completion

April 1, 2020

Study Completion

May 30, 2020

Last Updated

July 31, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Available. Timeframe: 2018-2021
Access Criteria
Accredited researchers. The protocol is available in Spanish and will be provided by contacting the principal investigator.

Locations

ES(1)