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

• ClinicalTrials.gov Identifier: NCT03184805
• Recruitment Status: Terminated
• First Posted: June 14, 2017
• Last Update Posted: May 22, 2018
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Yonsei University

Tracking Information

• First Submitted Date: June 7, 2017
• First Posted Date: June 14, 2017
• Last Update Posted Date: May 22, 2018
• Actual Study Start Date: June 23, 2017
• Actual Primary Completion Date: April 9, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: STOPping Versus Continuing Antiplatelet Therapy During Noncardiac Surgery and Procedures After Next Generation Drug-eluting Stent Implantation
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Coronary Artery Disease

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 17, 2018): 140
• Original Estimated Enrollment (submitted: June 8, 2017): 2400
• Actual Study Completion Date: April 9, 2018
• Actual Primary Completion Date: April 9, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 19 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT03184805
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Yonsei University
• Study Sponsor: Yonsei University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Yonsei University
• Verification Date: May 2018