A Phase 4 interventional study of Aspirin only and No antiplatelet therapy in Antiplatelet Drugs, sponsored by Jung-min Ahn. Completed at 35 sites in 3 countries. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by Jung-min Ahn · Phase 4, Interventional, and Treatment
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.
Subjects who can not be randomized due to any reason will be enrolled at observational group.
Jung-min Ahn is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Aspirin only
Drug: No antiplatelet therapy
Aspirin only during surgery
No antiplatelet therapy will be during surgery
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.
Time frame: 30 days
The event rate of all cause death
Time frame: 30 days
The event rate of cardiac death
Time frame: 30 days
The event rate of myocardial infarction
Time frame: 30 days
The event rate of stroke
Time frame: 30 days
The event rate of stent thrombosis
Time frame: 30 days
The event rate of repeat revascularization
Time frame: 30 days
The event rate of life threatening bleeding
Time frame: 30 days
The event rate of major bleeding
Time frame: 30 days
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.
Time frame: 30 days
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.
Time frame: 30 days
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.
Time frame: 30 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Jung-min Ahn