Status:
COMPLETED
Recto Colonic Endoscopic Mucosal Resection and Polypectomy Under Clopidogrel
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Polyps
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The endoscopic management of patients on anti platelet agents (APA) is a wide problem, with prevalence of patients on this type of therapy steadily increasing. The benefit / risk balance to stop or co...
Detailed Description
The endoscopic management of patients on anti platelet agents (APA) is a wide problem, due to the dramatically increasing prevalence of patients on these therapies. The benefit / risk balance to stop ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years, male or female
- Polypectomy AND / OR mucosectomy (EMR) performed on clopidogrel and/or aspirin during a colonoscopy with inability to defer action
- Taking a single daily dose of clopidogrel long-term (more than 3 months) or under treatment with clopidogrel and aspirin (aspirin \< 375 mg more than 3 months) in the prevention of cardiovascular and thromboembolic risk with a major or medium - secondary prevention
- Affiliation to the regime of national health protection
- Informed consent and patient's written obtained
- No participation in another clinical study
Exclusion
- Contraindications to the achievement of a lower gastrointestinal endoscopy
- Taking a single daily dose of clopidogrel or other anti-platelet, anti vitamin K (AVK), heparin or anti bi aggregation in the context of cardiovascular prevention
- Taking chronic anti inflammatory drug (at least once weekly)
- Resection technique submucosal dissection
- Haemorrhagic disease, disorders of hemostasis and coagulation (PT \<60%, aPTT\> 40 sec. And platelets \<100000/mm3), hematologic malignancy, chronic liver cirrhosis classified as Child Pugh B or C, acute or chronic renal failure
- Acute Coronary Syndrome \<3 months or not received percutaneous coronary intervention (PCI).
- Angioplasty with placement of a stent drug evaluation (out of context of acute coronary syndrome) \<3 months.
- Angioplasty with placement of a bare metal stent (out of context of acute coronary syndrome) \<4 weeks.
- Pregnant women, nursing
- Not signing the written consent and / or mental disabilities of the subject making its participation in the trial impossible
Key Trial Info
Start Date :
May 14 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2017
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01807169
Start Date
May 14 2013
End Date
November 7 2017
Last Update
August 6 2018
Active Locations (3)
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1
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France, 33400
2
Centre Hospitalier Universitaire de Brest
Brest, France, 29609
3
Centre Hospitalier Universitaire de Nice
Nice, France, 06003