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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
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Do-Yoon Kang, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Antiplatelet Drugs Drug: Aspirin only Drug: No antiplatelet therapy Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The event rate of all cause death [ Time Frame: 30 days ]
  2. The event rate of cardiac death [ Time Frame: 30 days ]
  3. The event rate of myocardial infarction [ Time Frame: 30 days ]
  4. The event rate of stroke [ Time Frame: 30 days ]
  5. The event rate of stent thrombosis [ Time Frame: 30 days ]
  6. The event rate of repeat revascularization [ Time Frame: 30 days ]
  7. The event rate of life threatening bleeding [ Time Frame: 30 days ]
  8. The event rate of major bleeding [ Time Frame: 30 days ]
  9. 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.


  10. 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.


  11. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Jung-Hee Ham, RN, Project leader +82230104728 cvcrc5@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpa-gu, Korea, Republic of, 138-736
Contact: Do-yoon Kang, MD       kdy1218@gmail.com   
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       mdbklee@kangwon.ac.kr   
Principal Investigator: Bong-Ki Lee, MD         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Jae-whan Lee, MD       myheart@cnu.ac.kr   
Principal Investigator: Jae-whan Lee, MD         
Kangbuk Samsung Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Jong-young Lee, MD       jyleeheart@naver.com   
Principal Investigator: Jong-young Lee, MD         
Sponsors and Collaborators
Do-Yoon Kang
CardioVascular Research Foundation, Korea
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Responsible Party: Do-Yoon Kang, Clinical Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02797548    
Other Study ID Numbers: AMCCV2016-10
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Do-Yoon Kang, Asan Medical Center:
drug-eluting stent
antiplatelet therapy
noncardiac surgery
Additional relevant MeSH terms:
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Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics