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

Antiplatelet Drugs Clinical Trial

— ASSURE-DES  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02797548
• Other study ID #: AMCCV2016-10
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 16, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1010
• Est. completion date: December 31, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antiplatelet Drugs

Intervention

Drug:
• Aspirin only
Aspirin only during surgery
• No antiplatelet therapy
No antiplatelet therapy will be during surgery

Locations

Country	Name	City	State
India	Jaslok Hospital	Mumbai
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon
Korea, Republic of	Dong-A Medical Center	Busan
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	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	Chungnam National University Hospital	Daejeon
Korea, Republic of	The Catholic University of Korea, Daejeon St. Mary's Hosptial	Daejeon
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Wonkwang University Sanbon Hospital	Gunpo
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Chosun University Hospital	Gwangju
Korea, Republic of	Wonkwang University Hospital	Iksan
Korea, Republic of	National Health Insurance Service Ilsan Hospital	Ilsan
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Sejong Chungnam National University Hospital	Sejong
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Ewha Womans University Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Eunpyeong St. Mary's Hospital	Seoul
Korea, Republic of	Wonju Severance Christian Hospital	Wonju
Korea, Republic of	Yongin Severance Hospital	Yongin
Turkey	Bagcilar Education and Training Hospital	Istanbul
Turkey	SBU Bakirkoy Dr.Sadi Konuk Education and Training Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Jung-min Ahn	CardioVascular Research Foundation, Korea

Countries where clinical trial is conducted

India,  Korea, Republic of,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The event rate of all cause death		30 days
Secondary	The event rate of cardiac death		30 days
Secondary	The event rate of myocardial infarction		30 days
Secondary	The event rate of stroke		30 days
Secondary	The event rate of stent thrombosis		30 days
Secondary	The event rate of repeat revascularization		30 days
Secondary	The event rate of life threatening bleeding		30 days
Secondary	The event rate of major bleeding		30 days
Secondary	Quality of life score assessed by the EQ-5D-5L	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.	30 days
Secondary	Quality of life score assessed by Health-related Quality of Life Instrument with 8 Items (HINT-8)	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.	30 days
Secondary	Cost-effective analysis	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.	30 days