Patients on Antithrombotics for Colonoscopy | NCT03363061

Studies
Patients on Antithrombotics for Colonoscopy

NCT03363061

Sponsor

Chinese University of Hong Kong

Status

Recruiting

Last Update Posted

Jan 18, 2022Actual

Enrollment

6,000Estimated

Phase

Not provided

Conditions

Antithrombotics
Colonoscopy

Interventions

Not provided

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 8, 2017Actual

Primary Completion Date

Nov 30, 2027Estimated

Completion Date

Nov 30, 2028Estimated

First Submitted Date

Nov 30, 2017

First Submission Date that Met QC Criteria

Nov 30, 2017

First Posted Date

Dec 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2022

Last Update Posted Date

Jan 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mak Wing Yan, Associate professor, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Name	Class
Beijing Friendship Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The use of antithrombotics (antiplatelet agents and anticoagulants) is increasing with an aging global population.Management of antithrombotics in patients undergoing invasive procedures including gastrointestinal endoscopy remains a challenge. Management approach includes taking a precarious balance between the risk of thromboembolism after interruption of antithrombotics and risk of bleeding with the continuation of antithrombotics. Colonoscopy remains one of the commonest endoscopic procedures performed. The optimal management strategy of different antithrombotics during colonoscopy remains unclear.

Detailed Description

The use of antithrombotics (antiplatelet agents and anticoagulants) is increasing with an aging global population. Cardiovascular disease is a leading cause of death worldwide. Clinical Practice Research Datalink (CPRD) GOLD database suggests that over 915 000 people in the UK have suffered a myocardial infarction and over 1.3 million are living with angina in 2013. Two percent of people in developed countries are on long-term anticoagulation and up to 10% in the elderly population. Management of antithrombotics in patients undergoing invasive procedures including gastrointestinal endoscopy remains a challenge. Management approach includes taking a precarious balance between the risk of thromboembolism after interruption of antithrombotics and risk of bleeding with the continuation of antithrombotics. The availability of new antithrombotic agents adds to the complexity of antithrombotic management during endoscopy. Warfarin has been the only oral anticoagulant available until the introduction of direct oral anticoagulants (DOACs). Newer antiplatelet agents (prasugrel and ticagrelor, vorapaxar) are becoming more commonly used for the treatment of the acute coronary syndrome.

There remain gaps in the management approach of patients receiving antithrombotics and requiring endoscopy. It is still uncertain of the actual bleeding risk associated with antithrombotic use during endoscopy. Colonoscopy remains one of the commonest endoscopic procedures performed. It is the gold standard for direct evaluation of the colon for patients with the suspected colonic disease. It is also used as a screening test for prevention of colorectal cancer by colonoscopic polypectomy of precancerous polyps.The optimal management strategy of different antithrombotics during colonoscopy remains unclear.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Antithrombotics		The patients should be on antithrombotics on the day of colonoscopy arrangement

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Delayed post polypectomy bleeding	Delayed post polypectomy bleeding is defined as blood per rectum occurring after colonoscope has been retracted from the anus to 30 days after the procedure requiring hospitalization or treatment.	Within 30 days

Secondary Outcomes

Measure	Description	Time Frame
Immediate post polypectomy bleeding	Immediate post polypectomy bleeding is defined as bleeding at the time of colonoscopy after polypectomy and requiring endoscopic intervention at the same colonoscopy.	During Colonoscopy
Serious cardiovascular event

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must be over 18 years of age
Patients undergoing elective colonoscopy for any indication, who are receiving antithrombotics
Informed consent is obtained

Exclusion Criteria:

Patients under 18 years of age
Inability to give informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients receiving antithrombotics at colonoscopy arrangement and undergoing elective colonoscopy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Moe Htet Kyaw, MBBS	Contact	35053476		moehkyaw@cuhk.edu.hk
Ka Man Kee, MPH	Contact	35053855		carmenkee@cuhk.edu.hk

Overall Officials

Name	Affiliation	Role
Moe Htet Kyaw, MBBS	Chinese University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital	Recruiting	Hong Kong			Hong Kong

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32931958	Derived	Jiang W, Suen BY, Ho HT, Ching JYL, Chan FKL, Mak JWY. Impact of Physicians' and Patients' Compliance on Outcomes of Colonoscopic Polypectomy With Anti-Thrombotic Therapy. Clin Gastroenterol Hepatol. 2021 Dec;19(12):2559-2566.e1. doi: 10.1016/j.cgh.2020.09.019. Epub 2020 Sep 12.