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STOPping Versus Continuing Antiplatelet Therapy During Noncardiac Surgery and Procedures After Next Generation Drug-eluting Stent Implantation

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ClinicalTrials.gov Identifier: NCT03184805
Recruitment Status : Terminated (Investigator judged that this study can not be maintained because participant registration rate is low.)
First Posted : June 14, 2017
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE June 7, 2017
First Posted Date  ICMJE June 14, 2017
Last Update Posted Date May 22, 2018
Actual Study Start Date  ICMJE June 23, 2017
Actual Primary Completion Date April 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
  • A composite of cardiac death [ Time Frame: 1 day after discharging from the hospital ]
    A composite of major perioperative adverse events
  • nonfatal myocardial infarction (MI) [ Time Frame: 1 day after discharging from the hospital ]
    A composite of major perioperative adverse events
  • cerebrovascular accident [ Time Frame: 1 day after discharging from the hospital ]
    A composite of major perioperative adverse events
  • definite or probable stent thrombosis [ Time Frame: 1 day after discharging from the hospital ]
    A composite of major perioperative adverse events
  • any revascularization and BARC(Bleeding Academic Research Consortium) ≥3 bleeding during index hospitalization for surgery or procedure [ Time Frame: 1 day after discharging from the hospital ]
    A composite of major perioperative adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE STOPping Versus Continuing Antiplatelet Therapy During Noncardiac Surgery and Procedures After Next Generation Drug-eluting Stent Implantation
Official Title  ICMJE Randomized Controlled Comparison: STOPping Versus Continuing Antiplatelet Therapy During Noncardiac Surgery and Procedures After Next Generation Drug-eluting Stent Implantation (STOP-ASP Trial)
Brief Summary Most previous trials support the absolute increase in bleeding risk with perioperative administration of antiplatelet. Furthermore, recent studies demonstrated that perioperative major bleeding may be related to increase cardiovascular risk. The investigators will compare the efficacy and safety of continuing versus stopping antiplatelet therapy during perioperative period in patients underwent PCI(Percutaneous Coronary Intervention) with next generation DES(Drug Eluting Stent).
Detailed Description Most current guidelines recommend to focus on continuing antiplatelet therapy (mostly with aspirin) during noncardiac surgery if possible. Although previous study showed efficacy of continuous antiplatelet therapy in reducing perioperative ischemic cardiovascular events, its effectiveness is still not clear between perioperative bleeding and ischemic risk. Most previous trials support the absolute increase in bleeding risk with perioperative administration of antiplatelet. Furthermore, recent studies demonstrated that perioperative major bleeding may be related to increase cardiovascular risk. The investigators will compare the efficacy and safety of continuing versus stopping antiplatelet therapy during perioperative period in patients underwent PCI(Percutaneous Coronary Intervention) with next generation DES(Drug Eluting Stent).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: Continuing aspirin
    Subject assigned to control arm will maintain antiplatelet therapy using aspirin only at least 7 days before surgery. If subject is taking one or more antiplatelet drugs, it should be changed (for subjects taking antiplatelet drug except aspirin at enrollment) or continued (for subject taking aspirin at enrollment) with low-dose, aspirin monotherapy before surgery. Cessation of clopidogrel, ticagrelor, and prasugrel should be started at least 5 days, 3 days and 7 days before surgery, respectively. Administration of aspirin will be started at the day of cessation of previous antiplatelet regimen and maintained until third postoperative day with 100 mg once a day.
  • Drug: Stopping aspirin
    Subject assigned to comparison arm will stop antiplatelet therapy before scheduled surgery or procedure. If subject is taking aspirin, clopidogrel, ticagrelor, or prasugrel, it should be discontinued for 7 days, 5 days, 3-5 days, and 7 days before surgery. Antiplatelet therapy may be restarted as previous regimen at fourth postoperative day or sooner unless significant bleeding risk or bleeding event occurs.
Study Arms  ICMJE
  • Active Comparator: Continuing aspirin
    Patients in the group may continue the administration of aspirin during perioperative period.
    Intervention: Drug: Continuing aspirin
  • Experimental: Stopping aspirin
    Patients in the group may stop medication of antiplatelet drugs during perioperative period.
    Intervention: Drug: Stopping aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 17, 2018)
140
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2017)
2400
Actual Study Completion Date  ICMJE April 9, 2018
Actual Primary Completion Date April 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 19-85 years
  • Planning of elective noncardiac surgery or invasive procedure
  • At least 1 year interval between the surgery or procedure and last PCI with next generation DES
  • Currently on antiplatelet therapy

Exclusion Criteria:

  • PCI with BMS(bare metal stent), 1st generation DES or bioresorbable vascular scaffold
  • Total length of inserted DES in the 3 vessels >60 mm
  • History of stent thrombosis
  • History of coronary artery bypass grafting surgery
  • Planned surgery or procedure with high bleeding risk including followings: intracranial neurosurgery, spinal canal surgery, and eye posterior chamber surgery, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), ampullary resection, endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy plus large-balloon papillary dilation, endoscopic ultrasonography-guided fine-needle aspiration (EUS-FNA) of cystic lesions
  • Left ventricular ejection fraction <40%
  • Myocardial infarction within 6 months
  • Any overt thromboembolism requiring medical surveillance and/or treatment
  • Any clinically overt sign of hemorrhage within 3 months
  • Anticoagulant therapy for any reason
  • Need of continuation or discontinuation of antiplatelet therapy during surgery or procedure at the discretion of cardiologist or operator
  • Any contraindication, adverse drug reaction or hypersensitivity to aspirin
  • Pregnant women or women with potential childbearing
  • Inability to understand or read the informed content
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03184805
Other Study ID Numbers  ICMJE 4-2017-0241
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP