Early Gastric CancerPhase 4NCT01621451
Does Early Re-administration of Aspirin/Clopidogrel Increase the Risk of Bleeding From Artificial Ulcer After EMR or ESD?
A Phase 4 study testing aspirin and/or clopidogrel in people with Early Gastric Cancer and Gastric Dysplasia, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Aspirin and/or clopidogrel users are increasing due to increased prevalence of cardiovascular or cerebrovascular disease with an aging society in Korea. Also, the patients having endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for early gastric cancer or gastric premalignant lesions… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Early Gastric Cancer, Gastric Dysplasia
- What is being tested?
- aspirin and/or clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Jun 2014
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have taken aspirin and/or clopidogrel for cardiovascular and/or cerebrovascular disease and are found to have early gastric cancer or premalignant lesions including adenoma and dysplasia by upper endoscopy.
Who cannot join
- Patients with known coagulopathy or abnormal coagulation tests (prothrombin time, partial thromboplastin time and platelet count)
- Patients receiving other antithrombotic, anticoagulant drugs
- Patients needing continuation of nonsteroidal anti-inflammatory drugs, cyclooxygenase-2 (COX-2) inhibitors, or steroid after EMR/ESD
- Patient with recent percutaneous coronary intervention (placement of drug eluting coronary artery stent within 12 months, bare metal coronary artery stents within 1 month)
- Patient's age > 80 year-old or < 18 year-old
- Patient with severe cardiovascular, pulmonary, hepatic, or renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Aspirin and/or clopidogrel users are increasing due to increased prevalence of cardiovascular or cerebrovascular disease with an aging society in Korea. Also, the patients having endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for early gastric cancer or gastric premalignant lesions including adenoma and dysplasia are increasing among aspirin and/or clopidogrel users. Practically, aspirin or clopidogrel is recommended to be stopped for 5~14 days before EMR or ESD because bleeding risk during or after procedure. And it is recommended to restart of aspirin and/or clopidogrel as soon as possible if immediate bleeding during or after the procedure is not occurred in consideration of thromboembolic risk. However, early restarting of aspirin and/or clopidogrel raise the risk of delayed bleeding and the risk of complications associated with delayed ulcer healing. Although it is important to determine the timing of restarting aspirin and/or clopidogrel in consideration of complications of post-EMR/ESD ulcer and thromboembolic risk, there is no definite guideline about the timing of restarting aspirin and/or clopidogrel.
This study is aimed to determine the timing of restarting aspirin and/or clopidogrel for the patients having EMR or ESD among aspirin and/or clopidogrel users. The investigators planned to compare the delayed bleeding rate and ulcer healing rate in patients with post-EMR/ESD ulcer when take proton pump inhibitor (pantoprazole 40 mg per day) between the patients restarting aspirin and/or clopidogrel within 3~4 days after the procedure and the patients restarting aspirin and/or clopidogrel 2 weeks after the procedure during 4 weeks. The primary endpoint is delayed ulcer bleeding rate at 4 weeks after EMR/ESD. The secondary end point is ulcer healing rate within 4 weeks.
- Conditions
- Early Gastric Cancer, Gastric Dysplasia
- Being tested
- aspirin and/or clopidogrel
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin and/or clopidogrelDrug
Patients who have taken aspirin and/or clopidogrel and are found to have early gastric cancer or gastric premalignant lesions including adenoma and dysplasia by upper endoscopy will be stopped aspirin and/or clopidogrel for 7 days before EMR/ESD. In immediate group, the patient will receive oral proton pump inhibitor (pantoprazole 40mg per day) for 4 weeks after EMR/ESD to treat their post-EMR/ESD ulcer.
aspirin and/or clopidogrelDrug
Patients who have taken aspirin and/or clopidogrel and are found to have early gastric cancer or gastric premalignant lesions including adenoma and dysplasia by upper endoscopy will be stopped aspirin and/or clopidogrel for 7 days before EMR/ESD.
In 2 weeks group, the patient will receive oral proton pump inhibitor (pantoprazole 40mg per day) for 4 weeks after EMR/ESD to treat their post-EMR/ESD ulcer.
| Study group | Role | What they receive |
|---|---|---|
| immediate | Active comparator | Patients who receive pantoprazole plus aspirin and/or clopidogrel within 3~4 days after EMR/ESD Receives: Drug: aspirin and/or clopidogrel |
| 2 weeks | Active comparator | Patients who receive pantoprazole plus aspirin and/or clopidogrel at 2 weeks after EMR/ESD Receives: Drug: aspirin and/or clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
delayed ulcer bleeding
Measured: 4 weeks
Secondary outcomes (1)
ulcer healing rate
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Principal investigator, Hwoon-Yong Jung, Asan Medical Center
- Investigators
- Hwoon-Yong Jung, professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621451
- Sponsor's protocol ID
- PZ-1001-403-NS
- Status last verified
- Nov 2012
- First submitted
- 13 Jun 2012
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Early Re-administration of Aspirin/Clopidogrel Increase the Risk of Bleeding From Artificial Ulcer After EMR or ESD?
- ClinicalTrials.gov ID
- NCT01621451
- Acronym / sponsor ID
- PZ-1001-403-NS
- Conditions
- Early Gastric Cancer, Gastric Dysplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Jun 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 18 Jun 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.
Aspirin and/or clopidogrel users are increasing due to increased prevalence of cardiovascular or cerebrovascular disease with an aging society in Korea. Also, the patients having endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for early gastric cancer or gastric premalignant lesions including adenoma and dysplasia are increasing among aspirin and/or clopidogrel users. Practically, aspirin or clopidogrel is recommended to be stopped for 5~14 days before EMR or ESD because bleeding risk during or after procedure. And it is recommended to restart of aspirin and/or clopidogrel as soon as possible if immediate bleeding during or after the procedure is not occurred in consideration of thromboembolic risk. However, early restarting of aspirin and/or clopidogrel raise the risk of delayed bleeding and the risk of complications associated with delayed ulcer healing. Although it is important to determine the timing of restarting aspirin and/or clopidogrel in consideration of complications of post-EMR/ESD ulcer and thromboembolic risk, there is no definite guideline about the timing of restarting aspirin and/or clopidogrel.
This study is aimed to determine the timing of restarting aspirin and/or clopidogrel for the patients having EMR or ESD among aspirin and/or clopidogrel users. The investigators planned to compare the delayed bleeding rate and ulcer healing rate in patients with post-EMR/ESD ulcer when take proton pump inhibitor (pantoprazole 40 mg per day) between the patients restarting aspirin and/or clopidogrel within 3~4 days after the procedure and the patients restarting aspirin and/or clopidogrel 2 weeks after the procedure during 4 weeks. The primary endpoint is delayed ulcer bleeding rate at 4 weeks after EMR/ESD. The secondary end point is ulcer healing rate within 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate | Active comparator | Drug: aspirin and/or clopidogrelPatients who receive pantoprazole plus aspirin and/or clopidogrel within 3~4 days after EMR/ESD |
| 2 weeks | Active comparator | Drug: aspirin and/or clopidogrelPatients who receive pantoprazole plus aspirin and/or clopidogrel at 2 weeks after EMR/ESD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have taken aspirin and/or clopidogrel for cardiovascular and/or cerebrovascular disease and are found to have early gastric cancer or premalignant lesions including adenoma and dysplasia by upper endoscopy.
Key exclusion criteria (6 listed)
- Patients with known coagulopathy or abnormal coagulation tests (prothrombin time, partial thromboplastin time and platelet count)
- Patients receiving other antithrombotic, anticoagulant drugs
- Patients needing continuation of nonsteroidal anti-inflammatory drugs, cyclooxygenase-2 (COX-2) inhibitors, or steroid after EMR/ESD
- Patient with recent percutaneous coronary intervention (placement of drug eluting coronary artery stent within 12 months, bare metal coronary artery stents within 1 month)
- Patient's age > 80 year-old or < 18 year-old
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 and/or clopidogrelPatients who have taken aspirin and/or clopidogrel and are found to have early gastric cancer or gastric premalignant lesions including adenoma and dysplasia by upper endoscopy will be stopped aspirin and/or clopidogrel for 7 days before EMR/ESD. In immediate group, the patient will receive oral proton pump inhibitor (pantoprazole 40mg per day) for 4 weeks after EMR/ESD to treat their post-EMR/ESD ulcer. | Drug | immediate |
| aspirin and/or clopidogrelPatients who have taken aspirin and/or clopidogrel and are found to have early gastric cancer or gastric premalignant lesions including adenoma and dysplasia by upper endoscopy will be stopped aspirin and/or clopidogrel for 7 days before EMR/ESD. In 2 weeks group, the patient will receive oral proton pump inhibitor (pantoprazole 40mg per day) for 4 weeks after EMR/ESD to treat their post-EMR/ESD ulcer. | Drug | 2 weeks |
Primary outcome
delayed ulcer bleeding
Time frame: 4 weeks
1 secondary outcome
ulcer healing rate
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 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.
Hwoon-Yong Jung, professor principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aspirin and/or clopidogrel in people with Early Gastric Cancer and Gastric Dysplasia, run by Asan Medical Center at 1 site in South Korea.
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 1 inclusion and 6 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 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delayed ulcer bleeding (time frame: 4 weeks). 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 22 Nov 2012; AzTrials last refreshed its copy on 7 Nov 2026.