Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centre of Postgraduate Medical Education | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The risk of bleeding after polypectomy of large colorectal polyps in patients taking aspirin is uncertain. This is a randomized, multi-center, placebo-controlled, double-blind study to compare the risk of significant bleeding after endoscopic polypectomy of large (>=10mm) colorectal polyps in patients continuing or discontinuing on daily acetylsalicylic acid (ASA) use. Eligible patients will be randomly assigned in a 1:1 ratio to a group taking 75mg daily ASA or placebo 7 days before and 14 days following polypectomy. The primary endpoint of the study is bleeding within 30 days from colorectal polypectomy. The secondary endpoints are composite cardiovascular events occurring between the date of randomization and 30 days after polypectomy.
Patients chronically taking aspirin (in prophylaxis doses 75-325 mg), with a diagnosis of colorectal polyps ≥ 10 mm in diameter will be enrolled on a routine polypectomy under hospitalization. Meeting the inclusion criteria, after informed consent and a cardiologist consent the patient will receive aspirin/placebo, and The Patient Diary to fill (Visit 1). The patient will be admitted to the Study Center in 6-7 days taking on the aspirin/placebo and prepared for the study (Visit 2). Patient will be under the care of a physician after polypectomy by a minimum of 6 hours. 14 days after polypectomy will be the first control visit, during which the physician will take back patient diary and pack treatment (Visit 3). 30 days after polypectomy will be the second control visit by phone (Visit 4). Patients will be monitored by looking at the end points.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Active Comparator | Patients with at least one large polyps taking aspirin in dose 75 mg daily for 21 days (7 days before and 14 days after polypectomy) |
|
| Placebo | Placebo Comparator | Patients with at least one large polyps taking placebo daily for 21 days (7 days before and 14 days after polypectomy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin (ASA) | Drug | Usage or withdrawal of aspirin (75mg daily per os) 7 days before and 14 days after polypectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant bleeding after colorectal polypectomy | Clinically significant bleeding after polypectomy - any extravasation of blood from the polypectomy site [immediate (30s after polypectomy), early (to 24ha after polypectomy) or delayed (24ha to 30 days after polypectomy)], with clinical and/or endoscopic and/or laboratory (Hb decline by more than 3 g%)symptoms and would require endoscopic intervention and/or surgical and/or blood transfusions; | within 30 days after polypectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of composite cardiovascular events, ending unplanned hospitalization in both groups aspirin and placebo | Composite cardiovascular events - acute coronary syndrome, transient ischemic attack (TIA)or stroke | in time from randomisation to 30 days after polipectomy |
| Proportion of clinically significant delayed bleeding in both groups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaminski F Michal, MD | Contact | 48 22 546 30 56 | mfkaminski@coi.waw.pl | |
| Pisera Malgorzata, MSc | Contact | 48 22 546 30 58 | mpisera@coi.waw.pl |
| Name | Affiliation | Role |
|---|---|---|
| Regula Jaroslaw, MD PhD | The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland | Study Director |
| Kaminski F Michal, MD | The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland |
Not provided
Not provided
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug |
|
| within 30 days after polipectomy |
| Pisera Malgorzata, MSc | The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland | Principal Investigator |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |