Pharmacokinetics of Oral Antiplatelet Agents After Distal Gastrectomy

NCT ID: NCT05543863

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-20

Study Completion Date

2023-05-31

Brief Summary

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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

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Conditions

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Stomach Neoplasm Cardiovascular Diseases Cerebrovascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyungpook National University Chilgok Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ji Yeon Park

Principle Investigator (Associate professor)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ji Yeon Park, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Surgery, Kyungpook National Univ. Chilgok Hosptal

Locations

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Dept. of Surgery, Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ji Yeon Park, MD

Role: CONTACT

+82+53+200+2714

Soye An

Role: CONTACT

+82-53-200-3065

Facility Contacts

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JI YEON PARK, MD

Role: primary

+82-53-200-2714

Other Identifiers

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KNUCH 2022-general-08

Identifier Type: -

Identifier Source: org_study_id

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