Pharmacokinetics of Oral Antiplatelet Agents After Distal Gastrectomy

Last updated: September 18, 2022
Sponsor: Kyungpook National University Chilgok Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Cardiovascular Disease

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT05543863
KNUCH 2022-general-08
  • Ages 18-90
  • All Genders

Study 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 postoperative bleeding complications and thromboembolic events.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with pathologically proven gastric cancer of clinical stage Iaccording to the AJCC 8th edition.
  • Patients who are scheduled to undergo distal gastrectomy (access: either minimallyinvasive surgery or open surgery)
  • Patients taking aspirin and/or clopidogrel for primary or secondary prevention forcardiovascular disease or cerebrovascular disease before surgery.
  • age 18 - 90 years
  • A person who voluntarily agrees to participate in this study and signs the consentform.

Exclusion

Exclusion Criteria:

  • Patients with coagulation disorder or abnormal findings in coagulation test (lowplatelet 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 postoperativebone marrow function and hematopoietic function (those with gastric cancer of clinicalstage 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 Design

Total Participants: 20
Study Start date:
August 20, 2022
Estimated Completion Date:
May 31, 2023

Connect with a study center

  • Dept. of Surgery, Kyungpook National University Chilgok Hospital

    Daegu, 41404
    Korea, Republic of

    Active - Recruiting

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