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Preoperative Aspirin and Postoperative Antiplatelets in Coronary Artery Bypass Grafting: The PAPA CABG Study (PAPA CABG)

2 août 2017 mis à jour par: Hamilton Health Sciences Corporation

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Anticipé)

150

Phase

Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Canada
- Ontario
  - Hamilton, Ontario, Canada, L8L 2X2
    - Hamilton General Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Objectif principal: Traitement
Répartition: Randomisé
Modèle interventionnel: Affectation factorielle
Masquage: Double

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Graft patency, MI, Death, Stroke

Mesures de résultats secondaires

Mesure des résultats
Bleeding, transfusion, re-exploration, Platelet function tests

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hamilton Health Sciences Corporation

Collaborateurs

Bristol-Myers Squibb

Les enquêteurs

Chercheur principal: Jack CJ Sun, MD, McMaster University
Directeur d'études: John W Eikelboom, MD, MSc, McMaster University
Chaise d'étude: Kevin HT Teoh, MD, McMaster University
Chaise d'étude: Salim Yusuf, MD, DPhil, McMaster University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Sun JC, Teoh KH, Lamy A, Sheth T, Ellins ML, Jung H, Yusuf S, Anand S, Connolly S, Whitlock RP, Eikelboom JW. Randomized trial of aspirin and clopidogrel versus aspirin alone for the prevention of coronary artery bypass graft occlusion: the Preoperative Aspirin and Postoperative Antiplatelets in Coronary Artery Bypass Grafting study. Am Heart J. 2010 Dec;160(6):1178-84. doi: 10.1016/j.ahj.2010.07.035.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juillet 2006

Achèvement primaire (Réel)

1 juin 2008

Achèvement de l'étude (Réel)

1 décembre 2008

Dates d'inscription aux études

Première soumission

26 mai 2006

Première soumission répondant aux critères de contrôle qualité