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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Continuing aspirin Drug: Stopping aspirin Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 23, 2017
Actual Primary Completion Date : April 9, 2018
Actual Study Completion Date : April 9, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Continuing aspirin
Patients in the group may continue the administration of aspirin during perioperative period.
 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.
Experimental: Stopping aspirin
Patients in the group may stop medication of antiplatelet drugs during perioperative period.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. A composite of cardiac death [ Time Frame: 1 day after discharging from the hospital ]
    A composite of major perioperative adverse events

  2. nonfatal myocardial infarction (MI) [ Time Frame: 1 day after discharging from the hospital ]
    A composite of major perioperative adverse events

  3. cerebrovascular accident [ Time Frame: 1 day after discharging from the hospital ]
    A composite of major perioperative adverse events

  4. definite or probable stent thrombosis [ Time Frame: 1 day after discharging from the hospital ]
    A composite of major perioperative adverse events

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT03184805


Locations
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Korea, Republic of
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03184805    
Other Study ID Numbers: 4-2017-0241
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
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