Impact of continuous antiplatelet therapy versus temporary interruption of antiplatelet therapy on the occurrence of bleeding during colonoscopic polypectomy

Phase 4

Recruiting

• Conditions: colonic adenomas; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12616000895482
• Lead Sponsor: The Alfred

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 992

Inclusion Criteria

*Any patient aged >18 years scheduled for routine colonoscopy who is
* On single agent antiplatelet therapy: clopidogrel or prasugrel or ticagrelor
OR
* On dual antiplatelet agent: aspirin and clopidogrel or prasugrel or ticagrelor

Exclusion Criteria

One or more of the following criteria precludes trial eligibility
Liver cirrhosis
* Chronic renal impairment (eGFR less than or equal to 30)
* History of a bleeding diathesis
* Thrombocytopenia of any cause (Platelet count less than or equal to 90)
* Other concurrent anticoagulation/antiplatelet agents
* Percutaneous coronary intervention
- with bare metal stent within the last 30 days
- with drug eluding stent within the last 12 months
*Acute coronary syndrome within the last 90 days
* Any other concern by treating physician(s)
* Inability to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome<br>The primary aim of the study is to investigate in patients, who are already receiving antiplatelet therapy and are undergoing elective colonoscopy, whether or not continuation of antiplatelet therapy” differs, in terms of occurrence of bleeds, to temporary interruption of antiplatelet therapy”. A composite primary end point will be used. This will include: <br>* Use of rescue endoscopic clips post-polypectomy to control immediate intra-procedural bleeding <br>OR <br>* A major bleed, which must be symptomatically or clinically overt and is associated with an unplanned admission or re-admission to hospital for rectal bleeding<br>OR<br>* Bleeding that directly contributes to death<br><br>At 30 days post-procedure, a phone call will be made to the patient and all outcomes will be recorded on the case record forms.[30 day follow up.]