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

Coronary Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03184805
• Other study ID #: 4-2017-0241
• Status: Terminated
• Phase: N/A
• Start date: June 23, 2017
• Est. completion date: April 9, 2018

Study information

• Verified date: May 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 140
• Est. completion date: April 9, 2018
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite of cardiac death	A composite of major perioperative adverse events	1 day after discharging from the hospital
Primary	nonfatal myocardial infarction (MI)	A composite of major perioperative adverse events	1 day after discharging from the hospital
Primary	cerebrovascular accident	A composite of major perioperative adverse events	1 day after discharging from the hospital
Primary	definite or probable stent thrombosis	A composite of major perioperative adverse events	1 day after discharging from the hospital
Primary	any revascularization and BARC(Bleeding Academic Research Consortium) =3 bleeding during index hospitalization for surgery or procedure	A composite of major perioperative adverse events	1 day after discharging from the hospital