Antiplatelet Drugs
Conditions
Keywords
drug-eluting stent, antiplatelet therapy, noncardiac surgery
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.
Interventions
DRUGAspirin only
Aspirin only during surgery
DRUGNo antiplatelet therapy
No antiplatelet therapy will be during surgery
Sponsors
CardioVascular Research Foundation, Korea
Jung-min Ahn
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| The event rate of repeat revascularization | 30 days | — |
| The event rate of all cause death | 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. |
| The event rate of life threatening bleeding | 30 days | — |
Countries
India, South Korea, Turkey (Türkiye)
Outcome results
None listed