Pharmacokinetics of Oral Antiplatelet Agents After Distal Gastrectomy

Cardiovascular Diseases Clinical Trial

Official title:

Impact of Radial Distal Gastrectomy for Gastric Cancer on the Pharmacokinetics of Oral Antiplatelet Agents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05543863
• Other study ID #: KNUCH 2022-general-08
• Status: Recruiting
• Start date: August 20, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2022
• Source: Kyungpook National University Chilgok Hospital
• Contact: Ji Yeon Park, MD
• Phone: +82+53+200+2714
• Email: jybark99[@]hanmail.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cerebrovascular Disease
• Cerebrovascular Disorders
• Stomach Neoplasm
• Stomach Neoplasms

Intervention

Diagnostic Test:
• Platelet function testing
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

Locations

Country	Name	City	State
Korea, Republic of	Dept. of Surgery, Kyungpook National University Chilgok Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University Chilgok Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	platelet function testing at 5 days	Difference in the platelet function testing results between before and 5 days after surgery.	5 days
Secondary	Platelet function testing at 3 months	Difference in the platelet function testing results between before and 3 months after surgery	3 months
Secondary	postoperative complications	¦ incidence of postoperative bleeding and thromboembolic events within 3 months after surgery	3 months