Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery
ASSURE-DES
1 other identifier
interventional
1,010
3 countries
35
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2017
Longer than P75 for phase_4
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2016
CompletedFirst Posted
Study publicly available on registry
June 13, 2016
CompletedStudy Start
First participant enrolled
March 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedNovember 5, 2024
November 1, 2024
7.2 years
June 8, 2016
November 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The event rate of composite event of all-cause death, stent thrombosis, myocardial infarction, and stroke
A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.
30 days
Secondary Outcomes (11)
The event rate of all cause death
30 days
The event rate of cardiac death
30 days
The event rate of myocardial infarction
30 days
The event rate of stroke
30 days
The event rate of stent thrombosis
30 days
- +6 more secondary outcomes
Study Arms (2)
Aspirin only
EXPERIMENTALNo antiplatelet therapy
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Planned non-cardiac surgery at least after 12 months of implantation of drug eluting stent
- Low or intermediate risk level surgery
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jung-min Ahnlead
- CardioVascular Research Foundation, Koreacollaborator
Study Sites (35)
Jaslok Hospital
Mumbai, India
Asan Medical Center
Seoul, Songpa-gu, 138-736, South Korea
Hallym University Sacred Heart Hospital
Anyang, South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
Dong-A Medical Center
Busan, South Korea
Pusan National University Yangsan Hospital
Busan, South Korea
Soon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
Chungbuk National University Hospital
Cheonju, South Korea
Gangwon National Univ. Hospital
Chuncheon, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
The Catholic University of Korea, Daejeon St. Mary's Hosptial
Daejeon, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Wonkwang University Sanbon Hospital
Gunpo, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Chosun University Hospital
Gwangju, South Korea
Wonkwang University Hospital
Iksan, South Korea
National Health Insurance Service Ilsan Hospital
Ilsan, South Korea
Pusan National University Hospital
Pusan, South Korea
Sejong Chungnam National University Hospital
Sejong, South Korea
Ewha Womans University Medical Center
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
Hanyang University Seoul Hospital
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
Yongin Severance Hospital
Yŏngin, South Korea
Bagcilar Education and Training Hospital
Istanbul, Turkey (Türkiye)
SBU Bakirkoy Dr.Sadi Konuk Education and Training Hospital
Istanbul, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 39217573DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 8, 2016
First Posted
June 13, 2016
Study Start
March 16, 2017
Primary Completion
May 31, 2024
Study Completion
May 31, 2024
Last Updated
November 5, 2024
Record last verified: 2024-11