SEARCHInvestigating Synergistic Effects of Apixaban With Dual Anti-Platelet Therapy (DAPT) in Lowering Platelet Reactivity and Thrombin Generation
Collecte de données
Données recueillies à un instant précis - TransversaleMaladies Cardiovasculaires+2
+ Maladies Cardiaques
+ Maladies vasculaires
Cas témoins
Analyse de profils avec et sans la maladie pour comprendre ce qui pourrait l'avoir favorisée.Résumé
Date de début de l'étude : 10 juillet 2018
Date à laquelle le premier participant a commencé l'étude.Combination anti-platelet therapies particularly those combining aspirin with a P2Y12 antagonist (DAPT) are regarded as the current standard of care therapy for patients with Acute Coronary Syndrome (ACS). As thrombin potently induces platelet dense granular release and causes secondary adenosine 5'-diphosphate (ADP)-mediated P2Y12 receptor activation, apixaban via inhibition of thrombin generation may exhibit synergistic activity with direct P2Y12 receptor blockers such as clopidogrel or ticagrelor. The results from the study will provide a clearer understanding of how these antithrombotic agents work in combination and how the anti-Xa, apixaban, may reduce the contribution of thrombin and general platelet reactivity when used alone and in combination with antiplatelet agents. This study does NOT involve administration of medication to subjects. Experiments will be performed on donated blood samples from participants.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.40 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cas témoins
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 74 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures (i.e., venipuncture). 2. Male or female at least 18 years of age but equal to or less than 75 years of age. 3. Females must be post-menopausal for at least one year or surgically sterile for at least 6 months. 4. For ACS Subjects: 1. Documented prior history of ACS within the past 12 months. 2. Currently prescribed a DAPT medication regimen of aspirin (81mg) plus a P2Y12 inhibitor, clopidogrel or ticagrelor, and none of the excluded medications listed in Exclusion Criteria #4. 3. Have taken DAPT medication for at least 7 days as prescribed prior to blood collection. 5. For Healthy Subjects: 1. Currently not prescribed and/or taking any of the excluded medications listed in Exclusion Criteria #4. Exclusion Criteria: 1. Male or female less than 18 or greater than 75 years of age. 2. No prior history of ACS within 12 months (unless Healthy Subject) 3. Pregnancy 4. Currently prescribed and/or taking any of the following medications: Within the last 1 month: * PAR-1 antagonist (vorapaxar/Zontivity®) * Coumadin® * Heparin including low molecular weight heparin (enoxaparin/Lovenox®) * Factor Xa inhibitors (rivaroxaban/Xarelto®, apixaban/Eliquis®, edoxaban/Savaysa®, betrixaban/Bevyxxa®) * Direct thrombin inhibitors (hirudin, bivalirudin/Angiomax®, dabigatran/Pradaxa®) Within last 10 days: * Glycoprotein IIb/IIIa inhibitors (Eptifibatide/Integrilin®, Tirofiban/Aggrastat®, Abciximab/ReoPro®) * Acetylsalicylic Acid/Aspirin products (Alka-Seltzer®, Goody Powder®, BC Powder®, Pepto Bismol®, Aggrenox®) (except aspirin as prescribed for DAPT participants) Within last 3 days: * Phosphodiesterase inhibitors (cilostazol/Pletal®) * Adenosine reuptake inhibitors (dipyridamole/Persantine®) * NSAIDs * Decongestants * Antidepressants or Anti-anxiety medications: * Selective Serotonin Reuptake Inhibitors (SSRI) (fluoxetine/Prozac®, sertraline/Zoloft®, paroxetine/Paxil®) * Selective Norepinephrine Reuptake Inhibitors (SNRI) (venlafaxine/Effexor® or duloxetine/Cymbalta®) 5. Diagnosed with or possessing significant renal dysfunction as defined by the physician/investigator.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site