Clinical trial NCT02797548: Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery
Official title: Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Antiplatelet Drugs
Keywords: drug-eluting stent
antiplatelet therapy
noncardiac surgery
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2016-06-13
Enrollment: 1010
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The event rate of composite event of all-cause death, stent thrombosis, myocardial infarction, and stroke
timeFrame: 30 days
Secondary outcomes:
measure: The event rate of all cause death
timeFrame: 30 days
measure: The event rate of cardiac death
timeFrame: 30 days
measure: The event rate of myocardial infarction
timeFrame: 30 days
measure: The event rate of stroke
timeFrame: 30 days
measure: The event rate of stent thrombosis
timeFrame: 30 days
measure: The event rate of repeat revascularization
timeFrame: 30 days
measure: The event rate of life threatening bleeding
timeFrame: 30 days
measure: The event rate of major bleeding
timeFrame: 30 days
measure: Quality of life score assessed by the EQ-5D-5L
timeFrame: 30 days
measure: Quality of life score assessed by Health-related Quality of Life Instrument with 8 Items (HINT-8)
timeFrame: 30 days
measure: Cost-effective analysis
timeFrame: 30 days
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Jaslok Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Busan
country: Korea, Republic of
facility: Dong-A Medical Center
city: Busan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Cheonju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon St. Mary's Hosptial
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Gunpo
country: Korea, Republic of
facility: Wonkwang University Sanbon Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Ilsan
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Sejong
country: Korea, Republic of
facility: Sejong Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Yŏngin
country: Korea, Republic of
facility: Yongin Severance Hospital
city: Istanbul
country: Turkey
facility: Bagcilar Education and Training Hospital
city: Istanbul
country: Turkey
facility: SBU Bakirkoy Dr.Sadi Konuk Education and Training Hospital
Study officials:
References: