Colonic PolypsNCT02865824
Polypectomy in Patients Taking Dual Antiplatelet Agents
A study testing Continue thienopyridine and Discontinue thienopyridine in people with Colonic Polyps, run by Incheon St.Mary's Hospital at 1 site in South Korea.
Trial 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)… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- Continue thienopyridine and Discontinue thienopyridine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over the age of 20 years undergoing routine colonoscopy
- patients who are taking DAT (dual antiplatelet therapy)
Who cannot join
- patients not abiding to the study protocol
- history of inflammatory bowel disease
- severe comorbidities
- American Society of Anesthesiology class III or more
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Antiplatelets Discontinuation in Patients Receiving Polypectomy: Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Colonic Polyps
- Being tested
- Continue thienopyridine, Discontinue thienopyridine
- Keywords
- Colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continue thienopyridineDrug
Also called DAT group
Patients continue dual antiplatelet therapies before colonoscopy. The patients continue taking thienopyridine before colonoscopy
Discontinue thienopyridineDrug
Also called Aspirin group
Patients who are taking dual antiplatelet therapies stop thienopyridine one week before they undergo colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Continue thienopyridine | Active comparator | Patients continue dual antiplatelet therapy (DAT) before colonoscopy and all polyps are removed by cold snare polypectomy. Receives: Drug: Continue thienopyridine |
| Discontinue thienopyridine | Experimental | Patients discontinue thienopyridines for 1 week before colonoscopy and all polyps are removed by cold snare polypectomy. Receives: Drug: Discontinue thienopyridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed bleeding requiring hemostasis after polypectomy
Measured: 2 weeks
Secondary outcomes (1)
immediate bleeding requiring hemostasis after polypectomy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incheon St.Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Sung Kim, Incheon St.Mary's Hospital
- Investigators
- Joon Sung Kim, MD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865824
- Sponsor's protocol ID
- CMC
- Status last verified
- Aug 2016
- First submitted
- 1 Aug 2016
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Won D, Kim JS, Ji JS, Kim BW, Choi H. Cold Snare Polypectomy in Patients Taking Dual Antiplatelet Therapy: A Randomized Trial of Discontinuation of Thienopyridines. Clin Transl Gastroenterol. 2019 Oct;10(10):e00091. doi: 10.14309/ctg.0000000000000091.
PubMed 31599746
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antiplatelets Discontinuation in Patients Receiving Polypectomy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02865824
- Acronym / sponsor ID
- CMC
- Conditions
- Colonic Polyps
- Keywords
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Incheon St.Mary's HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continue thienopyridine | Active comparator | Drug: Continue thienopyridinePatients continue dual antiplatelet therapy (DAT) before colonoscopy and all polyps are removed by cold snare polypectomy. |
| Discontinue thienopyridine | Experimental | Drug: Discontinue thienopyridinePatients discontinue thienopyridines for 1 week before colonoscopy and all polyps are removed by cold snare polypectomy. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients over the age of 20 years undergoing routine colonoscopy
- patients who are taking DAT (dual antiplatelet therapy)
Key exclusion criteria (5 listed)
- patients not abiding to the study protocol
- history of inflammatory bowel disease
- severe comorbidities
- American Society of Anesthesiology class III or more
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continue thienopyridineAlso: DAT groupPatients continue dual antiplatelet therapies before colonoscopy. The patients continue taking thienopyridine before colonoscopy | Drug | Continue thienopyridine |
| Discontinue thienopyridineAlso: Aspirin groupPatients who are taking dual antiplatelet therapies stop thienopyridine one week before they undergo colonoscopy | Drug | Discontinue thienopyridine |
Primary outcome
Delayed bleeding requiring hemostasis after polypectomy
Time frame: 2 weeks
1 secondary outcome
immediate bleeding requiring hemostasis after polypectomy
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Derived from this study: PubMed 31599746Won D, Kim JS, Ji JS, Kim BW, Choi H. Cold Snare Polypectomy in Patients Taking Dual Antiplatelet Therapy: A Randomized Trial of Discontinuation of Thienopyridines. Clin Transl Gastroenterol. 2019 Oct;10(10):e00091. doi: 10.14309/ctg.0000000000000091.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joon Sung Kim, MD principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continue thienopyridine and Discontinue thienopyridine in people with Colonic Polyps, run by Incheon St.Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed bleeding requiring hemostasis after polypectomy (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02865824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.