E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post polypectomy bleeding |
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E.1.1.1 | Medical condition in easily understood language |
Bleeding after removal of polyps from colon |
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E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to investigate the risk of post polypectomy bleeding after polypectomy of sessile polyps ≤ 20 mm in diameter in patients on uninterrupted Clopidogrel therapy before polypectomy |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients referred to an elective colonoscopy at HRH (screening, symptom or control) • In therapy with Clopidogrel (75 mg per day) alone or in combination with ASA • The patient requires polypectomy of at least one sessile polyp ≤ 20 mm, and no polyps >20 mm or pedunculated polyps are found • The patient is categorised as at low risk of thrombotic events at the time of the diagnostic colonoscopy, assessed by the responsible doctor, according to the standard guidelines • Age ≥ 18 years
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E.4 | Principal exclusion criteria |
• High-risk of thromboembolic event: o < 6 weeks since uncomplicated coronary event with or without revascularization (Percutaneous coronary intervention (PCI)/bare-metal stent (BMS), coronary artery bypass grafting (CABG)) o < 3 months since uncomplicated coronary event with revascularization (PCI/drug-eluting stent (DES)) o <12 months since complicated coronary event (e.g. reinfarction, stent thrombosis) o <1 month in stabile coronary artery disease (CAD) with revascularization (PCI/BMS) o <3 month since stroke or transient ischemic attack • Inability to provide informed consent (e.g. mental impairment) • Not able to read and understand Danish • Cannot be reached by telephone for follow-up • In therapy with other antithrombotic medication (except ASA)) such as vitamin-K antagonists (e.g. Warfarin, Phenprocoumon) or NOAK´s (e.g. Pradaxa®, Xarelto®) • American Society of Anaesthesiology classification class IV • Fertile women NOT taking anticonception (spiral or hormones). Menopause is defined as at least 12 months of no menstruation before enrollment • Pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
• Clinically significant immediate post polypectomy bleeding: defined as bleeding observed by the endoscopist during the procedure persisting more than 5 minutes despite irrigation and use of adrenalin injection or endo-clips • Clinically significant delayedpost polypectomy bleeding: defined as bleeding that required hospitalisation, red cell transfusion or endoscopic re-evaluation in the period after the end of the procedure and up to 30 days after the procedure.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After inclusion of 90 patients an interim analysis will be conducted and after inclusion and follow-up of all 180 participants |
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E.5.2 | Secondary end point(s) |
• Visually observed passage per rectum of red or dark blood in the stool – observed by the patient in the period after the end of the procedure and up to 30 days after the procedure. • Contact with healthcare services (incl. doctor on call), that did not lead to admission to the hospital, because of bleeding per rectum in the period after the end of the procedure and up to 30 days after the procedure. • Thromboembolic events occurring in the period 5 days before the procedure and up to 30 days after the procedure
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After inclusion of 90 patients an interim analysis will be conducted and after inclusion and follow-up of all 180 participants |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |