Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Clinical Impact of Applying Pharmacogenetic Algorithms to Individualize Dosing of Warfarin in Patients Being Initiated on Oral Anticoagulation
Brief Summary: The purpose of this study is to determine whether DNA analysis improves the efficiency of dosing and safety in patients who are being started on warfarin therapy.Warfarin, a blood thinner (anticoagulant) prescribed to 1-2 million patients in the United States, is a leading cause of drug-related adverse events (e.g., severe bleeding), in large part due to dramatic (20-fold) differences between individuals in dose requirements. At least half of this variability now can be explained by 3 common genetic variants, age, body size, and sex; however, warfarin therapy continues to begin with the same dose in every patient with the correct individual dose determined by trial and error. This study proposes to determine genetic variations the same day from DNA simply obtained by swabbing the inside of the cheek and use this information to determine the proper dose regimen individually in each patient. The aim is to show that the investigators can achieve more rapid, efficient, and safe dosing in up to 500-1000 individuals who are initiating warfarin therapy for various clotting disorders across a large healthcare system in order to demonstrate improved dosing effectiveness, efficiency, and safety with genetic-based dosing, which could lead to a nationwide application resulting in as much as a $1 billion dollar annual benefit in healthcare outcomes.


Options:
A: Arm Label: Standard IWPC warfarin dosing algorithm; Type: ACTIVE_COMPARATOR; Interventions: Genetic: IWPC adapted genotype-guided dosing algorithm for warfarin | Arm Label: Modified IWPC warfarin dosing algorithm; Type: EXPERIMENTAL; Interventions: Genetic: Modified IWPC genetic-guided warfarin dosing algorithm | Arm Label: Historical controls; Type: OTHER; Interventions: Other: Standard of care treatment | Intervention Type: GENETIC; Name: IWPC adapted genotype-guided dosing algorithm for warfarin; Assigned to Arm(s): Standard IWPC warfarin dosing algorithm | Intervention Type: GENETIC; Name: Modified IWPC genetic-guided warfarin dosing algorithm; Assigned to Arm(s): Modified IWPC warfarin dosing algorithm | Intervention Type: OTHER; Name: Standard of care treatment; Assigned to Arm(s): Historical controls
B: Arm Label: "Individual" or "standard" rFSH dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: rFSH drug dose | Arm Label: "Standard" rFSH dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: "Standard" rFSH dose | Intervention Type: DRUG; Name: rFSH drug dose; Assigned to Arm(s): "Individual" or "standard" rFSH dose | Intervention Type: DRUG; Name: "Standard" rFSH dose; Assigned to Arm(s): "Standard" rFSH dose
C: Arm Label: A - coded unit ID; Type: EXPERIMENTAL; Interventions: Other: clinical decision support | Arm Label: B - coded unit ID; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: clinical decision support; Assigned to Arm(s): A - coded unit ID
D: Arm Label: A; Type: EXPERIMENTAL; Interventions: Other: Algorithm for phenprocoumon | Arm Label: B; Type: EXPERIMENTAL; Interventions: Other: algorithm for phenprocoumon | Arm Label: C; Type: ACTIVE_COMPARATOR; Interventions: Drug: Phenprocoumon | Intervention Type: OTHER; Name: Algorithm for phenprocoumon; Assigned to Arm(s): A | Intervention Type: OTHER; Name: algorithm for phenprocoumon; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Phenprocoumon; Assigned to Arm(s): C

Answer: A