Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery (ASSURE-DES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02797548|
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : June 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Antiplatelet Drugs||Drug: Aspirin only Drug: No antiplatelet therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery|
|Actual Study Start Date :||March 16, 2017|
|Estimated Primary Completion Date :||June 30, 2025|
|Estimated Study Completion Date :||December 31, 2025|
|Experimental: Aspirin only||
Drug: Aspirin only
Aspirin only during surgery
|Active Comparator: No antiplatelet therapy||
Drug: No antiplatelet therapy
No antiplatelet therapy will be during surgery
- The event rate of composite event of all-cause death, stent thrombosis, myocardial infarction, and stroke [ Time Frame: 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.
- 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797548
|Contact: Jung-Hee Ham, RN, Project email@example.com|
|Korea, Republic of|
|Asan Medical Center||Recruiting|
|Seoul, Songpa-gu, Korea, Republic of, 138-736|
|Contact: Do-yoon Kang, MD firstname.lastname@example.org|
|Principal Investigator: Do-yoon Kang, MD|
|Soon Chun Hyang University Hospital Cheonan||Recruiting|
|Cheonan, Korea, Republic of|
|Contact: Se-whan Lee, MD Lovelee93@hanmail.net|
|Principal Investigator: Se-whan Lee, MD|
|Gangwon National Univ. Hospital||Not yet recruiting|
|Chuncheon, Korea, Republic of|
|Contact: Bong-Ki Lee, MD email@example.com|
|Principal Investigator: Bong-Ki Lee, MD|
|Chungnam National University Hospital||Recruiting|
|Daejeon, Korea, Republic of|
|Contact: Jae-whan Lee, MD firstname.lastname@example.org|
|Principal Investigator: Jae-whan Lee, MD|
|Kangbuk Samsung Hospital||Not yet recruiting|
|Seoul, Korea, Republic of|
|Contact: Jong-young Lee, MD email@example.com|
|Principal Investigator: Jong-young Lee, MD|