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NCT02797548 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

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Study Design

Related Conditions & MeSH terms

Intervention

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