NCT02797548
Completed
Phase 4
Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery
Jung-min Ahn35 sites in 3 countries1,010 target enrollmentMarch 16, 2017
ConditionsAntiplatelet Drugs
Overview
- Phase
- Phase 4
- Intervention
- Aspirin only
- Conditions
- Antiplatelet Drugs
- Sponsor
- Jung-min Ahn
- Enrollment
- 1010
- Locations
- 35
- Primary Endpoint
- The event rate of composite event of all-cause death, stent thrombosis, myocardial infarction, and stroke
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Jung-min Ahn
Assistant Professor
Asan Medical Center
Eligibility 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
Arms & Interventions
Aspirin only
Intervention: Aspirin only
No antiplatelet therapy
Intervention: No antiplatelet therapy
Outcomes
Primary Outcomes
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 Outcomes
- The event rate of all cause death(30 days)
- The event rate of stroke(30 days)
- The event rate of stent thrombosis(30 days)
- The event rate of cardiac death(30 days)
- The event rate of myocardial infarction(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(30 days)
- Quality of life score assessed by Health-related Quality of Life Instrument with 8 Items (HINT-8)(30 days)
- Cost-effective analysis(30 days)
Study Sites (35)
Loading locations...
Similar Trials
Completed
Not Applicable
The Perioperative Management of Anti-thrombotic Drug RegistrySurgeryPerioperative/Postoperative ComplicationsNCT03695159University of Texas Southwestern Medical Center288
Recruiting
Phase 4
Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent ImplantationAntiplatelet AgentsPerioperative CareNCT06723145Kyoto University1,200
Terminated
Not Applicable
PeriOperative Bridging - Perioperative Anticoagulation in the Setting of Recent Intracoronary Drug Eluting StentsStent ThrombosisNCT00606151The Cleveland Clinic60
Recruiting
Not Applicable
Perioperative Antiplatelet therapy in patients with drug-eluting Stent undergoing noncardiac SURgEryKCT0002907Asan Medical Center1,000
Completed
Not Applicable
Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac PatientsSurgical Procedure, Non-cardiacCardiovascular Disease PatientsPerioperative PeriodNCT01897220Charles University, Czech Republic1,200