Pharmacokinetics of Oral Antiplatelet Agents After Distal Gastrectomy

Recruiting

• Conditions: Stomach Neoplasm; Cerebrovascular Disease; Cardiovascular Diseases

• Registration Number: NCT05543863
• Lead Sponsor: Kyungpook National University Chilgok Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-20
• Status Verified: 2022-09
• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-16
• Last Update Submitted: 2022-09-18
• Last Update Posted: 2022-09-21
• Primary Completion: 2023-03-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
platelet function testing at 5 days	5 days	Difference in the platelet function testing results between before and 5 days after surgery.

Secondary Outcome Measures

Name	Time	Method
postoperative complications	3 months	■ incidence of postoperative bleeding and thromboembolic events within 3 months after surgery
Platelet function testing at 3 months	3 months	Difference in the platelet function testing results between before and 3 months after surgery

Trial Locations

Locations (1)

Dept. of Surgery, Kyungpook National University Chilgok Hospital; 🇰🇷 Daegu, Korea, Republic of