Stomach NeoplasmNCT05543863
Pharmacokinetics of Oral Antiplatelet Agents After Distal Gastrectomy
An observational study of Stomach Neoplasm and Cardiovascular Diseases, run by Kyungpook National University Chilgok Hospital at 1 site in South Korea.
Trial summary
This study is aimed to investigate the changes in pharmacokinetics and efficacy of antiplatelet agents before and after distal gastrectomy in gastric cancer patients taking oral antiplatelet agents for primary or secondary treatment for cardiovascular disease and to evaluate its impact on the occurrence of… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stomach Neoplasm, Cardiovascular Diseases, Cerebrovascular Disease
- What is being tested?
- Platelet function testing
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Aug 2022to 31 May 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are taking antiplatelet agents and scheduled for distal gastrectomy for gastric cancer
Who may be able to join
- Patients diagnosed with pathologically proven gastric cancer of clinical stage I according to the AJCC 8th edition.
- Patients who are scheduled to undergo distal gastrectomy (access: either minimally invasive surgery or open surgery)
- Patients taking aspirin and/or clopidogrel for primary or secondary prevention for cardiovascular disease or cerebrovascular disease before surgery.
- age 18 - 90 years
- A person who voluntarily agrees to participate in this study and signs the consent form.
Who cannot join
- Patients with coagulation disorder or abnormal findings in coagulation test (low platelet count, prolonged PT/aPTT)
- Patients taking other anticoagulants in combination
- Patients with imparied liver or renal function that may affect drug metabolism.
- Impaired liver function: liver cirrhosis Impaired renal function: CKD grade 3 or higher
- Patients requiring adjuvant chemotherapy after surgery that may affect postoperative bone marrow function and hematopoietic function (those with gastric cancer of clinical stage II or more according to the AJCC 8th edition)
- Patients participating in other clinical trials within 6 months
- Vulnerable patients (pregnant women, those with cognitive impairment, etc)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Dept. of Surgery, Kyungpook National University Chilgok Hospital
Daegu, 41404
JI YEON PARK, MD, +82-53-200-2714, jybark99@hanmail.net
Ji Yeon Park, MD
About this study
Official title: Impact of Radial Distal Gastrectomy for Gastric Cancer on the Pharmacokinetics of Oral Antiplatelet Agents
This study is aimed to investigate the changes in pharmacokinetics and efficacy of antiplatelet agents before and after distal gastrectomy in gastric cancer patients taking oral antiplatelet agents for primary or secondary treatment for cardiovascular disease and to evaluate its impact on the occurrence of postoperative bleeding complications and thromboembolic events.
- Being tested
- Platelet function testing
- Medical subject headings
- Stomach Neoplasms, Cardiovascular Diseases, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet function testingDiagnostic test
platelet function testing (Platelet function analyzer-100 (PFA-100) collagen epinephrine closure time, VerifyNowⓇ Assays (aspirin, P2Y12)) before surgery and 5 days, 3 months after surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet function testing at 5 days
Difference in the platelet function testing results between before and 5 days after surgery.
Measured: 5 days
Secondary outcomes (2)
Platelet function testing at 3 months
Difference in the platelet function testing results between before and 3 months after surgery
Measured: 3 months
postoperative complications
■ incidence of postoperative bleeding and thromboembolic events within 3 months after surgery
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start20 Aug 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Chilgok Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Yeon Park, Kyungpook National University Chilgok Hospital
- Investigators
- Ji Yeon Park, MD, Principal investigator, Dept. of Surgery, Kyungpook National Univ. Chilgok Hosptal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543863
- Sponsor's protocol ID
- KNUCH 2022-general-08
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Radial Distal Gastrectomy for Gastric Cancer on the Pharmacokinetics of Oral Antiplatelet Agents
- ClinicalTrials.gov ID
- NCT05543863
- Acronym / sponsor ID
- KNUCH 2022-general-08
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kyungpook National University Chilgok HospitalUniversity, hospital or other
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 16 Sep 2022 (actual)
- 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.
This study is aimed to investigate the changes in pharmacokinetics and efficacy of antiplatelet agents before and after distal gastrectomy in gastric cancer patients taking oral antiplatelet agents for primary or secondary treatment for cardiovascular disease and to evaluate its impact on the occurrence of postoperative bleeding complications and thromboembolic events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are taking antiplatelet agents and scheduled for distal gastrectomy for gastric cancer
Key inclusion criteria (5 listed)
- Patients diagnosed with pathologically proven gastric cancer of clinical stage I according to the AJCC 8th edition.
- Patients who are scheduled to undergo distal gastrectomy (access: either minimally invasive surgery or open surgery)
- Patients taking aspirin and/or clopidogrel for primary or secondary prevention for cardiovascular disease or cerebrovascular disease before surgery.
- age 18 - 90 years
- A person who voluntarily agrees to participate in this study and signs the consent form.
Key exclusion criteria (7 listed)
- Patients with coagulation disorder or abnormal findings in coagulation test (low platelet count, prolonged PT/aPTT)
- Patients taking other anticoagulants in combination
- Patients with imparied liver or renal function that may affect drug metabolism.
- Impaired liver function: liver cirrhosis Impaired renal function: CKD grade 3 or higher
- Patients requiring adjuvant chemotherapy after surgery that may affect postoperative bone marrow function and hematopoietic function (those with gastric cancer of clinical stage II or more according to the AJCC 8th edition)
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 |
|---|---|---|
| Platelet function testingplatelet function testing (Platelet function analyzer-100 (PFA-100) collagen epinephrine closure time, VerifyNowⓇ Assays (aspirin, P2Y12)) before surgery and 5 days, 3 months after surgery | Diagnostic test | – |
Primary outcome
platelet function testing at 5 days
Time frame: 5 days
Difference in the platelet function testing results between before and 5 days after surgery.
2 secondary outcomes
Platelet function testing at 3 months
Time frame: 3 months
postoperative complications
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Ji Yeon Park, MD principal investigator
Dept. of Surgery, Kyungpook National Univ. Chilgok Hosptal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasm and Cardiovascular Diseases, run by Kyungpook National University Chilgok Hospital 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 5 inclusion and 7 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 21 Sep 2022. 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.
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 Ji Yeon Park, MD (+82+53+200+2714, jybark99@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet function testing at 5 days (time frame: 5 days). 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 21 Sep 2022.