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

Primary Purpose

Coronary Artery Disease

Status

Terminated

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Continuing aspirin

Stopping aspirin

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continuing aspirin

Stopping aspirin

Arm Description

Patients in the group may continue the administration of aspirin during perioperative period.

Patients in the group may stop medication of antiplatelet drugs during perioperative period.

Outcomes

Primary Outcome Measures

A composite of cardiac death

A composite of major perioperative adverse events

nonfatal myocardial infarction (MI)

A composite of major perioperative adverse events

cerebrovascular accident

A composite of major perioperative adverse events

definite or probable stent thrombosis

A composite of major perioperative adverse events

any revascularization and BARC(Bleeding Academic Research Consortium) ≥3 bleeding during index hospitalization for surgery or procedure

A composite of major perioperative adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT03184805

First Posted

June 7, 2017

Last Updated

May 17, 2018

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03184805

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Terminated

Why Stopped

Investigator judged that this study can not be maintained because participant registration rate is low.

Study Start Date

June 23, 2017 (Actual)

Primary Completion Date

April 9, 2018 (Actual)

Study Completion Date

April 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Continuing aspirin

Arm Type

Active Comparator

Arm Description

Patients in the group may continue the administration of aspirin during perioperative period.

Arm Title

Stopping aspirin

Arm Type

Experimental

Arm Description

Patients in the group may stop medication of antiplatelet drugs during perioperative period.

Intervention Type

Drug

Intervention Name(s)

Continuing aspirin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Stopping aspirin

Intervention Description

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.

Primary Outcome Measure Information:

Title

A composite of cardiac death

Description

A composite of major perioperative adverse events

Time Frame

1 day after discharging from the hospital

Title

nonfatal myocardial infarction (MI)

Description

A composite of major perioperative adverse events

Time Frame

1 day after discharging from the hospital

Title

cerebrovascular accident

Description

A composite of major perioperative adverse events

Time Frame

1 day after discharging from the hospital

Title

definite or probable stent thrombosis

Description

A composite of major perioperative adverse events

Time Frame

1 day after discharging from the hospital

Title

any revascularization and BARC(Bleeding Academic Research Consortium) ≥3 bleeding during index hospitalization for surgery or procedure

Description

A composite of major perioperative adverse events

Time Frame

1 day after discharging from the hospital

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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