Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery

NCT ID: NCT02797548

Last Updated: 2024-11-05

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1010 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-16

Study Completion Date

2024-05-31

Brief Summary

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The purpose of this study is to evaluate the safety and effectiveness of perioperative antiplatelet therapy in patients with drug-eluting stent undergoing non-cardiac surgery.

Detailed Description

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Subjects who can not be randomized due to any reason will be enrolled at observational group.

Conditions

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Antiplatelet Drugs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aspirin only

Group Type EXPERIMENTAL

Aspirin only

Intervention Type DRUG

Aspirin only during surgery

No antiplatelet therapy

Group Type ACTIVE_COMPARATOR

No antiplatelet therapy

Intervention Type DRUG

No antiplatelet therapy will be during surgery

Interventions

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Aspirin only

Aspirin only during surgery

Intervention Type DRUG

No antiplatelet therapy

No antiplatelet therapy will be during surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Planned non-cardiac surgery at least after 12 months of implantation of drug eluting stent
* Low or intermediate risk level surgery
* Written informed consent

Exclusion Criteria

* Acute coronary syndrome within 1 month
* Heart failure NYHA III to IV
* Contraindication to Aspirin
* On anticoagulant therapy
* Emergent surgery
* Cardiac surgery
* High bleeding risk surgeries, e.g., Intra-cranial surgery, Intra-spinal surgery, Retinal surgery
* Pregnancy or breast-feeding
* Life expectancy less than 1year
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Jung-min Ahn

OTHER

Sponsor Role lead

Responsible Party

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Jung-min Ahn

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Jaslok Hospital

Mumbai, , India

Site Status

Asan Medical Center

Seoul, Songpa-gu, South Korea

Site Status

Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, , South Korea

Site Status

Dong-A Medical Center

Busan, , South Korea

Site Status

Pusan National University Yangsan Hospital

Busan, , South Korea

Site Status

Soon Chun Hyang University Hospital Cheonan

Cheonan, , South Korea

Site Status

Chungbuk National University Hospital

Cheonju, , South Korea

Site Status

Gangwon National Univ. Hospital

Chuncheon, , South Korea

Site Status

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status

Yeungnam University Medical Center

Daegu, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

The Catholic University of Korea, Daejeon St. Mary's Hosptial

Daejeon, , South Korea

Site Status

Gangneung Asan Hospital

Gangneung, , South Korea

Site Status

Wonkwang University Sanbon Hospital

Gunpo, , South Korea

Site Status

Chonnam National University Hospital

Gwangju, , South Korea

Site Status

Chosun University Hospital

Gwangju, , South Korea

Site Status

Wonkwang University Hospital

Iksan, , South Korea

Site Status

National Health Insurance Service Ilsan Hospital

Ilsan, , South Korea

Site Status

Pusan National University Hospital

Pusan, , South Korea

Site Status

Sejong Chungnam National University Hospital

Sejong, , South Korea

Site Status

Ewha Womans University Medical Center

Seoul, , South Korea

Site Status

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Hallym University Kangnam Sacred Heart Hospital

Seoul, , South Korea

Site Status

Hanyang University Seoul Hospital

Seoul, , South Korea

Site Status

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Severance Hospital

Seoul, , South Korea

Site Status

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, , South Korea

Site Status

Wonju Severance Christian Hospital

Wŏnju, , South Korea

Site Status

Yongin Severance Hospital

Yŏngin, , South Korea

Site Status

Bagcilar Education and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

SBU Bakirkoy Dr.Sadi Konuk Education and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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India South Korea Turkey (Türkiye)

References

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Kang DY, Lee SH, Lee SW, Lee CH, Kim C, Jang JY, Mehta N, Oh JH, Cho YR, Yoon KH, Ahn SG, Lee JH, Cho DK, Kim Y, Kim J, Cho GH, Lee KS, Park H, Vural M, Lim YH, Park KH, Lee BK, Lee JY, Park HW, Yoon YH, Lee JH, Lee SY, Park KW, Kang J, Kim HK, Kang SH, Park JH, Choi IC, Yu CS, Yun SC, Park DW, Hong MK, Park SJ, Kim JS, Ahn JM; ASSURE DES Investigators. Aspirin Monotherapy vs No Antiplatelet Therapy in Stable Patients With Coronary Stents Undergoing Low-to-Intermediate Risk Noncardiac Surgery. J Am Coll Cardiol. 2024 Dec 10;84(24):2380-2389. doi: 10.1016/j.jacc.2024.08.024. Epub 2024 Aug 31.

Reference Type DERIVED
PMID: 39217573 (View on PubMed)

Other Identifiers

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AMCCV2016-10

Identifier Type: -

Identifier Source: org_study_id

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