Pharmacokinetics of Oral Antiplatelet Agents After Distal Gastrectomy

NCT05543863 | Unknown

• 1 other identifier: KNUCH 2022-general-08
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Neoplasm; Cardiovascular Diseases; Cerebrovascular Disease

Outcome Measures

Primary Outcomes (1)

• platelet function testing at 5 days

  Difference in the platelet function testing results between before and 5 days after surgery.

  5 days

Secondary Outcomes (2)

• Platelet function testing at 3 months

  3 months

• postoperative complications

  3 months

Interventions

Platelet function testing DIAGNOSTIC_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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kyungpook National University Chilgok Hospital: lead

Study Sites (1)

Dept. of Surgery, Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Stomach Neoplasms; Cardiovascular Diseases; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Ji Yeon Park, MD

  Dept. of Surgery, Kyungpook National Univ. Chilgok Hosptal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji Yeon Park, MD

CONTACT

+82+53+200+2714; jybark99@hanmail.net

Soye An

CONTACT

+82-53-200-3065; ss00yy00@naver.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator (Associate professor)

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: August 20, 2022
• Primary Completion: March 31, 2023
• Study Completion: May 31, 2023
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)