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Preoperative Aspirin and Postoperative Antiplatelets in Coronary Artery Bypass Grafting: The PAPA CABG Study (PAPA CABG)
Pilot Study of Preoperative Aspirin and Postoperative Clopidogrel's Effects on Graft Patency and Cardiac Events in Coronary Artery Bypass Surgery
Main Research Question(s):
What is the effect of continuing aspirin until the time of coronary artery bypass graft surgery and of adding clopidogrel to aspirin after coronary artery bypass graft surgery for preventing blockage of coronary grafts, heart attack, stroke, and death? To reliably answer this question requires a large randomised trial. Before applying for a major grant from the Canadian Institute for Health Research to do the large study we would like to perform a small pilot study of 150 patients to demonstrate that it is feasible to recruit patients and to use a new test called "CT angiography" to determine whether the bypass grafts are still working or have become blocked.
(ii) Why is this research important? Coronary artery bypass surgery has made a very important contribution to improving the health and survival of patients with advanced coronary artery disease but still has many problems. One in 10 patients experiences a heart attack at the time of surgery, 1 in 20 experiences a heart attack, stroke, or death during hospitalization, and 1 in 4 patients has at least 1 blocked graft within 1 year of surgery. Antiplatelet drugs such as aspirin and clopidogrel are effective for preventing heart attacks, strokes and deaths but aspirin is usually stopped before coronary artery bypass graft surgery because of concerns about increasing the risk of bleeding. The effectiveness of the combination of clopidogrel and aspirin after surgery has not been evaluated. Our pilot study will provide key information about feasibility that will help us to design and perform a large definitive study in the future.
(iii) What is being studied? We will be looking at blood flow in bypass grafts as well as the occurrence of heart attack, stroke, and death. For safety we will be looking at bleeding, transfusion, and need for further surgery because of bleeding. We will also perform laboratory tests of platelet function to measure and compare the effect of the study treatments to prevent blood clots from forming.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
BACKGROUND: Platelets play a central role in the pathogenesis of ischemic complications (coronary artery bypass graft occlusion, myocardial infarction, stroke) following CABG surgery. Aspirin and clopidogrel used alone or in combination are effective for preventing ischemic complications in a broad range of high risk patients. However aspirin is usually discontinued before CABG surgery because of concerns about bleeding while the combination of aspirin and clopidogrel has not been evaluated for preventing ischemic complications after CABG surgery.
OBJECTIVES: The overall objectives of our research are to compare the effectiveness and safety of aspirin vs placebo before bypass surgery, and clopidogrel plus aspirin vs aspirin alone after surgery, on:
- blockage of coronary artery bypass grafts, MI, stroke, or death at 30 days
- bleeding and need for transfusion after surgery The specific objective of the present pilot study is to demonstrate the feasibility of recruiting patients undergoing CABG surgery into this study and of performing CT angiography at 30 days to determine graft patency. We will also measure the effect of different antiplatelet treatments on platelet function and blood markers of systemic inflammation during the first 48 hours after surgery.
DESIGN: This is a 2x2 factorial study of 150 elective CABG patients who will be randomized to receive low dose aspirin (81mg/d) or placebo for 5 days prior to surgery and aspirin 325mg loading dose followed by 81 mg/d plus clopidogrel 75 mg/d versus aspirin 81 mg/d and placebo post operatively.
OUTCOME: graft patency measured by CT angiography, MI, stroke, death, bleeding, transfusion requirement, need for re-exploration surgery, and laboratory measures of platelet function and aspirin resistance (including 11-dehydro thromboxane B2).
SAMPLE SIZE: This is a pilot study designed primarily to demonstrate feasibility. We propose to recruit a total of 150 patients over a 12 month period (2-4 per week).
Studietype
Inschrijving (Verwacht)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Ontario
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Hamilton, Ontario, Canada, L8L 2X2
- Hamilton General Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients 18 years of age or older
- Undergoing on-pump, elective coronary artery bypass grafting with at least 2 free grafts
- Patient able to give informed consent
Exclusion Criteria:
- planned date of surgery is <5 days from planned recruitment date
- patient has clear indication for anticoagulation (eg. mechanical heart valve, atrial fibrillation) or ADP receptor antagonist (eg. drug-eluting stent)
- allergy to or intolerance of aspirin or clopidogrel
- history of bleeding diathesis, significant GI bleed, ICH, or liver failure
- Patient has known renal failure or contraindication for Cardiac CT Angio
- Patient has had previous cardiac surgery
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Dubbele
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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Graft patency, MI, Death, Stroke
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Secundaire uitkomstmaten
Uitkomstmaat |
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Bleeding, transfusion, re-exploration, Platelet function tests
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Jack CJ Sun, MD, McMaster University
- Studie directeur: John W Eikelboom, MD, MSc, McMaster University
- Studie stoel: Kevin HT Teoh, MD, McMaster University
- Studie stoel: Salim Yusuf, MD, DPhil, McMaster University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Myocardiale ischemie
- Hartziekten
- Hart-en vaatziekten
- Vaatziekten
- Arteriosclerose
- Arteriële occlusieve ziekten
- Hart-en vaatziekte
- Coronaire hartziekte
- Fysiologische effecten van medicijnen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Agenten van het perifere zenuwstelsel
- Enzymremmers
- Pijnstillers
- Sensorische systeemagenten
- Ontstekingsremmers, niet-steroïde
- Pijnstillers, niet-narcotisch
- Ontstekingsremmende middelen
- Antireumatische middelen
- Fibrinolytische middelen
- Fibrine modulerende middelen
- Bloedplaatjesaggregatieremmers
- Cyclo-oxygenaseremmers
- Antipyretica
- Purinerge P2Y-receptorantagonisten
- Purinerge P2-receptorantagonisten
- Purinerge antagonisten
- Purinerge middelen
- Aspirine
- Clopidogrel
Andere studie-ID-nummers
- 06-091
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Coronaire hartziekte
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Lawson Health Research InstituteVoltooidArteriosclerose van Arterial Coronary Artery Bypass GraftCanada
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Deutsches Herzzentrum MuenchenVoltooidArteriosclerose van Arterial Coronary Artery Bypass GraftDuitsland
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University Hospital, AngersWervingPopliteale slagaderbeknellingFrankrijk
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University Hospital, AngersVoltooidPoplitea Entrapment SyndroomFrankrijk
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Stanford UniversityIngetrokkenPoplitea Artery Entrapment Syndroom | Functioneel beknellingssyndroom van de arteria popliteaVerenigde Staten
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University Hospital, Strasbourg, FranceWervingEpistaxis, Anterior Ethmoid ArteryFrankrijk
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Resicardunion nationale de formation et d'evaluation en medecine cardio-vasculaireVoltooidHartfalen | Acute kransslagader syndroom | Coronaire Bypass Graft Stenose van Native Artery GraftFrankrijk
Klinische onderzoeken op Clopidogrel
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Chinese PLA General HospitalOnbekendGenotypering Begeleide geïndividualiseerde behandeling van clopidogrel en ticagrelor bij ACS (GI-CT)CLOPIDOGREL, SLECHT METABOLISME van (aandoening)China
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Korea University Anam HospitalVoltooid
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Ospedale San DonatoVoltooid
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University of PecsBeëindigdStabiele angina pectoris | Ad hoc percutane coronaire interventieHongarije
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Hospital Central San Luis Potosi, MexicoOnbekendAcute kransslagader syndroom
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University of North Carolina, Chapel HillVoltooid
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Seung-Jung ParkCardioVascular Research Foundation, KoreaVoltooid
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Deutsches Herzzentrum MuenchenBeëindigdCoronaire hartziekteDuitsland
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University of PecsHungarian Academy of Sciences; KRKAVoltooidCoronaire hartziekte | Percutane coronaire interventie