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Polypectomy in Patients Taking Dual Antiplatelet Agents

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ClinicalTrials.gov Identifier: NCT02865824
Recruitment Status : Unknown
Verified August 2016 by Joon Sung Kim, Incheon St.Mary's Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : August 15, 2016
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
Joon Sung Kim, Incheon St.Mary's Hospital

Brief Summary:
Current guidelines recommend discontinuation of antiplatelets (i.e clopidogrel) for 7 days in patients taking DAT (dual antiplatelet therapy) before colonoscopy and polypectomy. The purpose of this study was to examine if a) discontinuation of these drugs reduces bleeding risks during polypectomy and if b) discontinuation of these drugs increases the occurence of thromboembolic events.

Condition or disease Intervention/treatment Phase
Colonic Polyps Drug: Continue thienopyridine Drug: Discontinue thienopyridine Not Applicable

Detailed Description:
Patients taking dual antiplatelets (DAT) and who visited for colonoscopy were eligible for enrollment in this study. On enrollment, patients were randomized to two groups. One group continued DAT and the other group discontinued antiplatelets (i.e. clopidogrel, ticagrelor, prasugrel) for 7 days before colonoscopy. If polyps (≤1 cm) were observed during colonoscopy, they were removed by cold snare polypectomy. The primary aim was to compared the delayed bleeding rates of the two groups.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Antiplatelets Discontinuation in Patients Receiving Polypectomy: Randomized Controlled Trial
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Continue thienopyridine
Patients continue dual antiplatelet therapy (DAT) before colonoscopy and all polyps are removed by cold snare polypectomy.
Drug: Continue thienopyridine
Patients continue dual antiplatelet therapies before colonoscopy. The patients continue taking thienopyridine before colonoscopy
Other Name: DAT group

Experimental: Discontinue thienopyridine
Patients discontinue thienopyridines for 1 week before colonoscopy and all polyps are removed by cold snare polypectomy.
Drug: Discontinue thienopyridine
Patients who are taking dual antiplatelet therapies stop thienopyridine one week before they undergo colonoscopy
Other Name: Aspirin group




Primary Outcome Measures :
  1. Delayed bleeding requiring hemostasis after polypectomy [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. immediate bleeding requiring hemostasis after polypectomy [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients over the age of 20 years undergoing routine colonoscopy
  • patients who are taking DAT (dual antiplatelet therapy)

Exclusion Criteria:

  • patients not abiding to the study protocol
  • history of inflammatory bowel disease
  • severe comorbidities
  • American Society of Anesthesiology class III or more
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865824


Locations
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Korea, Republic of
Incheon St. Mary's Hospital
Incheon, Korea, Republic of
Sponsors and Collaborators
Incheon St.Mary's Hospital
Investigators
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Principal Investigator: Joon Sung Kim, MD The Catholic University of Korea
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joon Sung Kim, Doctor, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier: NCT02865824    
Other Study ID Numbers: CMC
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Joon Sung Kim, Incheon St.Mary's Hospital:
Colonoscopy
Additional relevant MeSH terms:
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Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics