Gastrointestinal HemorrhagePhase 4ASAPOLNCT01549418
The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Taking Aspirin
A Phase 4 study testing Aspirin (ASA) in people with Gastrointestinal Hemorrhage, run by Maria Sklodowska-Curie National Research Institute of Oncology.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage
- What is being tested?
- Aspirin (ASA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 760 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Sep 2015
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lifelong anticoagulant therapy with warfarin, acenocumarol
- Concurrent antiplatelet treatment with clopidogrel or ticlopidin
- Coagulation disorders INR > 1,5, APTT 2xnorm
- Known hemorrhagic disorder
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Gastrointestinal Hemorrhage
- Being tested
- Aspirin (ASA), Placebo
- Keywords
- 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
- Medical subject headings
- Gastrointestinal Hemorrhage, Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin (ASA)Drug
Also called Not yet named
Usage or withdrawal of aspirin (75mg daily per os) 7 days before and 14 days after polypectomy
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Aspirin (ASA) |
| Placebo | Placebo comparator | Patients with at least one large polyps taking placebo daily for 21 days (7 days before and 14 days after polypectomy) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: within 30 days after polypectomy
Secondary outcomes (2)
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
Measured: in time from randomisation to 30 days after polipectomy
Proportion of clinically significant delayed bleeding in both groups
Measured: within 30 days after polipectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education
- Responsible party
- Principal investigator, Jaroslaw Regula, Maria Sklodowska-Curie National Research Institute of Oncology
- Investigators
- Regula Jaroslaw, MD PhD, Study director, The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, PolandKaminski F Michal, MD, Study chair, The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, PolandPisera Malgorzata, MSc, Principal investigator, The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549418
- Sponsor's protocol ID
- ASAPOL
- Acronym
- ASAPOL
- Status last verified
- Mar 2012
- First submitted
- 6 Mar 2012
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01549418
- Acronym / sponsor ID
- ASAPOL / ASAPOL
- Conditions
- Gastrointestinal Hemorrhage
- Keywords
- Gastrointestinal bleeding, Lower gastrointestinal bleeding (LGIB), Polypectomy, Large colorectal polyps, ASA, Aspirin, Acetylsalicylic acid, Colorectal Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 9 Mar 2012 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: Aspirin (ASA)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 | Drug: PlaceboPatients with at least one large polyps taking placebo daily for 21 days (7 days before and 14 days after polypectomy) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Lifelong anticoagulant therapy with warfarin, acenocumarol
- Concurrent antiplatelet treatment with clopidogrel or ticlopidin
- Coagulation disorders INR > 1,5, APTT 2xnorm
- Known hemorrhagic disorder
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 |
|---|---|---|
| Aspirin (ASA)Also: Not yet namedUsage or withdrawal of aspirin (75mg daily per os) 7 days before and 14 days after polypectomy | Drug | Aspirin |
| Placebo | Drug | Placebo |
Primary outcome
Clinically significant bleeding after colorectal polypectomy
Time frame: within 30 days after 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;
2 secondary outcomes
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
Proportion of clinically significant delayed bleeding in both groups
Time frame: within 30 days after polipectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
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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.
Regula Jaroslaw, MD PhD study director
The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland
Kaminski F Michal, MD study chair
The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland
Pisera Malgorzata, MSc principal investigator
The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin (ASA) in people with Gastrointestinal Hemorrhage, run by Maria Sklodowska-Curie National Research Institute of Oncology.
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 5 inclusion and 4 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 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Kaminski F Michal, MD (48 22 546 30 56, mfkaminski@coi.waw.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant bleeding after colorectal polypectomy (time frame: within 30 days after polypectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2012.