- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03184805
STOPping Versus Continuing Antiplatelet Therapy During Noncardiac Surgery and Procedures After Next Generation Drug-eluting Stent Implantation
17. maj 2018 opdateret af: Yonsei University
Randomized Controlled Comparison: STOPping Versus Continuing Antiplatelet Therapy During Noncardiac Surgery and Procedures After Next Generation Drug-eluting Stent Implantation (STOP-ASP Trial)
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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
140
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Seoul, Korea, Republikken, 03722
- Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
19 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Continuing aspirin
Patients in the group may continue the administration of aspirin during perioperative period.
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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.
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Eksperimentel: Stopping aspirin
Patients in the group may stop medication of antiplatelet drugs during perioperative period.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
A composite of cardiac death
Tidsramme: 1 day after discharging from the hospital
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A composite of major perioperative adverse events
|
1 day after discharging from the hospital
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nonfatal myocardial infarction (MI)
Tidsramme: 1 day after discharging from the hospital
|
A composite of major perioperative adverse events
|
1 day after discharging from the hospital
|
cerebrovascular accident
Tidsramme: 1 day after discharging from the hospital
|
A composite of major perioperative adverse events
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1 day after discharging from the hospital
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definite or probable stent thrombosis
Tidsramme: 1 day after discharging from the hospital
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A composite of major perioperative adverse events
|
1 day after discharging from the hospital
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any revascularization and BARC(Bleeding Academic Research Consortium) ≥3 bleeding during index hospitalization for surgery or procedure
Tidsramme: 1 day after discharging from the hospital
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A composite of major perioperative adverse events
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1 day after discharging from the hospital
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. juni 2017
Primær færdiggørelse (Faktiske)
9. april 2018
Studieafslutning (Faktiske)
9. april 2018
Datoer for studieregistrering
Først indsendt
7. juni 2017
Først indsendt, der opfyldte QC-kriterier
8. juni 2017
Først opslået (Faktiske)
14. juni 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. maj 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. maj 2018
Sidst verificeret
1. maj 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Myokardieiskæmi
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Karsygdomme
- Åreforkalkning
- Arterielle okklusive sygdomme
- Koronar sygdom
- Koronararteriesygdom
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Blodpladeaggregationshæmmere
- Cyclooxygenase-hæmmere
- Antipyretika
- Aspirin
Andre undersøgelses-id-numre
- 4-2017-0241
Plan for individuelle deltagerdata (IPD)
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