Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation (NVAF) That Have Undergone a Percutaneous Coronary Intervention (PCI) With Stenting
Brief Summary: The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) \<= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome).

The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.


Options:
A: Arm Label: rivaroxaban 2.5 mg twice daily; Type: EXPERIMENTAL; Interventions: Drug: rivaroxaban 2.5 mg, Drug: rivaroxaban 15 mg, Drug: rivaroxaban 10 mg, Drug: aspirin (ASA), Drug: clopidogrel, Drug: prasugrel, Drug: ticagrelor | Arm Label: vitamin K antagonist (VKA); Type: EXPERIMENTAL; Interventions: Drug: aspirin (ASA), Drug: vitamin K antagonist (VKA), Drug: clopidogrel, Drug: prasugrel, Drug: ticagrelor | Arm Label: rivaroxaban 15 mg once daily; Type: EXPERIMENTAL; Interventions: Drug: rivaroxaban 15 mg, Drug: rivaroxaban 10 mg, Drug: clopidogrel, Drug: prasugrel, Drug: ticagrelor | Intervention Type: DRUG; Name: rivaroxaban 2.5 mg; Assigned to Arm(s): rivaroxaban 2.5 mg twice daily | Intervention Type: DRUG; Name: rivaroxaban 15 mg; Assigned to Arm(s): rivaroxaban 15 mg once daily, rivaroxaban 2.5 mg twice daily | Intervention Type: DRUG; Name: rivaroxaban 10 mg; Assigned to Arm(s): rivaroxaban 15 mg once daily, rivaroxaban 2.5 mg twice daily | Intervention Type: DRUG; Name: aspirin (ASA); Assigned to Arm(s): rivaroxaban 2.5 mg twice daily, vitamin K antagonist (VKA) | Intervention Type: DRUG; Name: vitamin K antagonist (VKA); Assigned to Arm(s): vitamin K antagonist (VKA) | Intervention Type: DRUG; Name: clopidogrel; Assigned to Arm(s): rivaroxaban 15 mg once daily, rivaroxaban 2.5 mg twice daily, vitamin K antagonist (VKA) | Intervention Type: DRUG; Name: prasugrel; Assigned to Arm(s): rivaroxaban 15 mg once daily, rivaroxaban 2.5 mg twice daily, vitamin K antagonist (VKA) | Intervention Type: DRUG; Name: ticagrelor; Assigned to Arm(s): rivaroxaban 15 mg once daily, rivaroxaban 2.5 mg twice daily, vitamin K antagonist (VKA)
B: Arm Label: Dabigatran 110 mg; Type: EXPERIMENTAL; Interventions: Drug: dabigatran 110 mg | Arm Label: Dabigatran 150 mg; Type: EXPERIMENTAL; Interventions: Drug: dabigatran 150 mg | Arm Label: Unfractionated Heparin; Type: ACTIVE_COMPARATOR; Interventions: Drug: unfractionated heparin | Intervention Type: DRUG; Name: dabigatran 110 mg; Assigned to Arm(s): Dabigatran 110 mg | Intervention Type: DRUG; Name: dabigatran 150 mg; Assigned to Arm(s): Dabigatran 150 mg | Intervention Type: DRUG; Name: unfractionated heparin; Assigned to Arm(s): Unfractionated Heparin
C: Arm Label: Dabigatran Etexilate 110mg; Type: EXPERIMENTAL; Interventions: Drug: Dabigatran Etexilate 110mg, Drug: Clopidogrel or Ticagrelor | Arm Label: Dabigatran Etexilate 150mg; Type: EXPERIMENTAL; Interventions: Drug: Dabigatran Etexilate 150mg, Drug: Clopidogrel or Ticagrelor | Arm Label: Warfarin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Warfarin 3mg, Drug: Aspirin, Drug: Clopidogrel or Ticagrelor, Drug: Warfarin 5mg, Drug: Warfarin 1mg | Intervention Type: DRUG; Name: Dabigatran Etexilate 110mg; Assigned to Arm(s): Dabigatran Etexilate 110mg | Intervention Type: DRUG; Name: Warfarin 3mg; Assigned to Arm(s): Warfarin | Intervention Type: DRUG; Name: Aspirin; Assigned to Arm(s): Warfarin | Intervention Type: DRUG; Name: Dabigatran Etexilate 150mg; Assigned to Arm(s): Dabigatran Etexilate 150mg | Intervention Type: DRUG; Name: Clopidogrel or Ticagrelor; Assigned to Arm(s): Warfarin | Intervention Type: DRUG; Name: Clopidogrel or Ticagrelor; Assigned to Arm(s): Dabigatran Etexilate 110mg | Intervention Type: DRUG; Name: Warfarin 5mg; Assigned to Arm(s): Warfarin | Intervention Type: DRUG; Name: Clopidogrel or Ticagrelor; Assigned to Arm(s): Dabigatran Etexilate 150mg | Intervention Type: DRUG; Name: Warfarin 1mg; Assigned to Arm(s): Warfarin
D: Arm Label: OAC alone; Type: EXPERIMENTAL; Interventions: Drug: OAC alone | Arm Label: OAC plus single APT; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: OAC alone; Assigned to Arm(s): OAC alone

Answer: C