The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Taking Aspirin (ASAPOL)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Hemorrhage |
Drug: Aspirin (ASA) Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Continuing or Discontinuing on Aspirin: a Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial |
- Clinically significant bleeding after colorectal polypectomy [ Time Frame: within 30 days after polypectomy ] [ Designated as safety issue: Yes ]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;
- Proportion of composite cardiovascular events, ending unplanned hospitalization in both groups aspirin and placebo [ Time Frame: in time from randomisation to 30 days after polipectomy ] [ Designated as safety issue: Yes ]Composite cardiovascular events - acute coronary syndrome, transient ischemic attack (TIA)or stroke
- Proportion of clinically significant delayed bleeding in both groups [ Time Frame: within 30 days after polipectomy ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 760 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Aspirin
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)
|
Drug: Aspirin (ASA)
Usage or withdrawal of aspirin (75mg daily per os) 7 days before and 14 days after polypectomy
Other Name: Not yet named
|
|
Placebo Comparator: Placebo
Patients with at least one large polyps taking placebo daily for 21 days (7 days before and 14 days after polypectomy)
|
Drug: Placebo |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 40 years or older
- Daily aspirin for primary or secondary prophylaxis
- Candidate for endoscopic polypectomy of at least one colorectal polyp 10mm or larger
- Signed written informed consent
- Written opinion from a cardiologist that the patient can cease taking aspirin for a period of 21 days in the peri-polypectomy period
Exclusion Criteria:
- Lifelong anticoagulant therapy with warfarin, acenocumarol
- Concurrent antiplatelet treatment with clopidogrel or ticlopidin
- Coagulation disorders INR > 1,5, APTT 2xnorm
- Known hemorrhagic disorder
Contacts and Locations| Contact: Kaminski F Michal, MD | 48 22 546 30 56 | mfkaminski@coi.waw.pl |
| Contact: Pisera Malgorzata, MSc | 48 22 546 30 58 | mpisera@coi.waw.pl |
| Study Director: | Regula Jaroslaw, MD PhD | The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland |
| Study Chair: | Kaminski F Michal, MD | The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland |
| Principal Investigator: | Pisera Malgorzata, MSc | The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland |
More Information
No publications provided
| Responsible Party: | Jaroslaw Regula, Professor in Gastroenterology, MD, PhD, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology |
| ClinicalTrials.gov Identifier: | NCT01549418 History of Changes |
| Other Study ID Numbers: | ASAPOL |
| Study First Received: | March 6, 2012 |
| Last Updated: | March 8, 2012 |
| Health Authority: | Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Poland: Ethics Committee |
Keywords provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:
|
Gastrointestinal bleeding Lower gastrointestinal bleeding (LGIB) Polypectomy Large colorectal polyps ASA Aspirin Acetylsalicylic acid Colorectal Neoplasms Intestinal Neoplasms |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Additional relevant MeSH terms:
|
Gastrointestinal Hemorrhage Hemorrhage Colonic Polyps Gastrointestinal Diseases Digestive System Diseases Pathologic Processes 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 Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013