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

NCT03184805 | Terminated DMC

• 1 other identifier: 4-2017-0241
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (5)

• A composite of cardiac death

  A composite of major perioperative adverse events

  1 day after discharging from the hospital

• nonfatal myocardial infarction (MI)

  A composite of major perioperative adverse events

  1 day after discharging from the hospital

• cerebrovascular accident

  A composite of major perioperative adverse events

  1 day after discharging from the hospital

• definite or probable stent thrombosis

  A composite of major perioperative adverse events

  1 day after discharging from the hospital

• 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

Study Arms (2)

Continuing aspirin

ACTIVE COMPARATOR

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

Drug: Continuing aspirin

Stopping aspirin

EXPERIMENTAL

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

Drug: Stopping aspirin

Interventions

Continuing aspirin DRUG

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.

Continuing aspirin

Stopping aspirin DRUG

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.

Stopping aspirin

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 14, 2017
• Study Start: June 23, 2017
• Primary Completion: April 9, 2018
• Study Completion: April 9, 2018
• Last Updated: May 22, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)