Pharmacokinetics of Oral Antiplatelet Agents After Distal Gastrectomy

September 18, 2022 updated by: Ji Yeon Park, Kyungpook National University Chilgok Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 41404
        • Recruiting
        • Dept. of Surgery, Kyungpook National University Chilgok Hospital
        • Contact:
        • Principal Investigator:
          • Ji Yeon Park, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are taking antiplatelet agents and scheduled for distal gastrectomy for gastric cancer

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
platelet function testing at 5 days
Time Frame: 5 days
Difference in the platelet function testing results between before and 5 days after surgery.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet function testing at 3 months
Time Frame: 3 months
Difference in the platelet function testing results between before and 3 months after surgery
3 months
postoperative complications
Time Frame: 3 months
■ incidence of postoperative bleeding and thromboembolic events within 3 months after surgery
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Chilgok Hospital

Investigators

  • Principal Investigator: Ji Yeon Park, MD, Dept. of Surgery, Kyungpook National Univ. Chilgok Hosptal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2022

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 18, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNUCH 2022-general-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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