STOPping Versus Continuing Antiplatelet Therapy During Noncardiac Surgery and Procedures After Next Generation Drug-eluting Stent Implantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Continuing aspirin Drug: Stopping aspirin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
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
|Korea, Republic of|
|Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine|
|Seoul, Korea, Republic of, 03722|