Pharmacokinetics of Oral Antiplatelet Agents After Distal Gastrectomy

Trial Title: Pharmacokinetics of Oral Antiplatelet Agents After Distal Gastrectomy

NCT ID: NCT05543863

Condition: Stomach Neoplasm
Cardiovascular Diseases
Cerebrovascular Disease

Conditions: Official terms:
Stomach Neoplasms
Cerebrovascular Disorders
Cardiovascular Diseases

Study type: Observational [Patient Registry]

Overall status: Unknown status

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Platelet function testing
Description: 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

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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
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)

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: No

Locations:

Facility:
Name: Dept. of Surgery, Kyungpook National University Chilgok Hospital

Address:
City: Daegu
Zip: 41404
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: JI YEON PARK, MD

Phone: +82-53-200-2714
Email: jybark99@hanmail.net

Investigator:
Last name: Ji Yeon Park, MD
Email: Principal Investigator

Start date: August 20, 2022

Completion date: May 31, 2023

Lead sponsor:
Agency: Kyungpook National University Chilgok Hospital
Agency class: Other

Source: Kyungpook National University Chilgok Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05543863