Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery (ASSURE-DES)

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.

Study Overview

• Status: Completed
• Conditions: Antiplatelet Drugs
• Intervention / Treatment: Drug: Aspirin only; Drug: No antiplatelet therapy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 1010
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Mumbai, India
    • Jaslok Hospital
• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Bucheon, Korea, Republic of
    • Soon Chun Hyang University Hospital Bucheon
  • Busan, Korea, Republic of
    • Dong-A Medical Center
  • Busan, Korea, Republic of
    • Pusan National University Yangsan Hospital
  • Cheonan, Korea, Republic of
    • Soon Chun Hyang University Hospital Cheonan
  • Cheonju, Korea, Republic of
    • Chungbuk National University Hospital
  • Chuncheon, Korea, Republic of
    • Gangwon National Univ. Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daegu, Korea, Republic of
    • Yeungnam University Medical Center
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Daejeon, Korea, Republic of
    • The Catholic University of Korea, Daejeon St. Mary's Hosptial
  • Gangneung, Korea, Republic of
    • GangNeung Asan Hospital
  • Gunpo, Korea, Republic of
    • Wonkwang University Sanbon Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Gwangju, Korea, Republic of
    • Chosun university hospital
  • Iksan, Korea, Republic of
    • Wonkwang University Hospital
  • Ilsan, Korea, Republic of
    • National Health Insurance Service Ilsan Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Hospital
  • Sejong, Korea, Republic of
    • Sejong Chungnam National University Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of
    • Hanyang University Seoul Hospital
  • Seoul, Korea, Republic of
    • Ewha Womans University Medical Center
  • Seoul, Korea, Republic of
    • Hallym University Kangnam Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
  • Wonju, Korea, Republic of
    • WonJu Severance Christian Hospital
  • Yŏngin, Korea, Republic of
    • Yongin Severance Hospital
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 138-736
      • Asan Medical Center
• Turkey
  • Istanbul, Turkey
    • Bagcilar Education and Training Hospital
  • Istanbul, Turkey
    • SBU Bakirkoy Dr.Sadi Konuk Education and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The event rate of all cause death		30 days
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 life threatening bleeding		30 days
The event rate of major bleeding		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.	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.	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.	30 days

Collaborators and Investigators

• Sponsor: Jung-min Ahn
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2017
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: June 8, 2016
• First Posted (Estimated): June 13, 2016

Study Record Updates

• Last Update Posted (Actual): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: drug-eluting stent; noncardiac surgery; antiplatelet therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Aspirin
• Other Study ID Numbers: AMCCV2016-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No