Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery
- Conditions
- Antiplatelet Drugs
- Interventions
- Registration Number
- NCT02797548
- Lead Sponsor
- Jung-min Ahn
- 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.
- Detailed Description
Subjects who can not be randomized due to any reason will be enrolled at observational group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1010
- Planned non-cardiac surgery at least after 12 months of implantation of drug eluting stent
- Low or intermediate risk level surgery
- Written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aspirin only Aspirin only - No antiplatelet therapy No antiplatelet therapy -
- Primary Outcome Measures
Name Time Method The event rate of composite event of all-cause death, stent thrombosis, myocardial infarction, and stroke 30 days 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.
- Secondary Outcome Measures
Name Time Method The event rate of all cause death 30 days The event rate of stroke 30 days The event rate of stent thrombosis 30 days The event rate of cardiac death 30 days The event rate of myocardial infarction 30 days The event rate of repeat revascularization 30 days The event rate of life threatening bleeding 30 days The event rate of major bleeding 30 days Quality of life score assessed by the EQ-5D-5L 30 days The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Higher score of EQ-5D and EQ VAS means the low quality of life. EQ-5D: the minimum and maximum values are 5 and 25 respectively. EQ VAS: the minimum and maximum values are 0 and 100 respectively.Quality of life score assessed by Health-related Quality of Life Instrument with 8 Items (HINT-8) 30 days HINT-8 was developed based on 4 health dimensions: physical, mental, social, and positive health dimensions. It consists of climbing stairs, endurance to pain, vitality, working, depression, memory, sleep, and happiness.
Higher score of HINT-8 means the high quality of life. The minimum and maximum values are 0 and 100 respectively if convert to a percentage.Cost-effective analysis 30 days Cost-effective analysis based on average treatment costs for two perioperative antiplatelet therapy_Aspirin only vs. No antiplatelet therapy_in patients with drug-eluting stent undergoing non-cardiac surgery.
Trial Locations
- Locations (35)
Gangwon National Univ. Hospital
🇰🇷Chuncheon, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Bagcilar Education and Training Hospital
🇹🇷Istanbul, Turkey
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Wonkwang University Sanbon Hospital
🇰🇷Gunpo, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Busan, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheonju, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan, Korea, Republic of
National Health Insurance Service Ilsan Hospital
🇰🇷Ilsan, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Songpa-gu, Korea, Republic of
Dong-A Medical Center
🇰🇷Busan, Korea, Republic of
Jaslok Hospital
🇮🇳Mumbai, India
The Catholic University of Korea, Daejeon St. Mary's Hosptial
🇰🇷Daejeon, Korea, Republic of
Ewha Womans University Medical Center
🇰🇷Seoul, Korea, Republic of
Sejong Chungnam National University Hospital
🇰🇷Sejong, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju, Korea, Republic of
Yongin Severance Hospital
🇰🇷Yŏngin, Korea, Republic of
SBU Bakirkoy Dr.Sadi Konuk Education and Training Hospital
🇹🇷Istanbul, Turkey
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of