Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-02-20 @ 3:33 PM
Study NCT ID:
NCT03669068
Status:
COMPLETED
Last Update Posted:
2020-07-31
First Post:
2018-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY
Sponsor:
Hospital Universitario Ramon y Cajal
Organization:
Study Overview
Official Title:
Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: A Prospective, Multicentre, and Observational Registry
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: