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: Arm 4; Type: ACTIVE_COMPARATOR; Interventions: Drug: (LMW) Heparin + Vitamin K Antagonist | Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Drug: Xarelto (Rivaroxaban, BAY59-7939) | Arm Label: Arm 2; Type: EXPERIMENTAL; Interventions: Drug: Xarelto (Rivaroxaban, BAY59-7939) | Arm Label: Arm 3; Type: EXPERIMENTAL; Interventions: Drug: Xarelto (Rivaroxaban, BAY59-7939) | Intervention Type: DRUG; Name: Xarelto (Rivaroxaban, BAY59-7939); Assigned to Arm(s): Arm 1 | Intervention Type: DRUG; Name: Xarelto (Rivaroxaban, BAY59-7939); Assigned to Arm(s): Arm 2 | Intervention Type: DRUG; Name: Xarelto (Rivaroxaban, BAY59-7939); Assigned to Arm(s): Arm 3 | Intervention Type: DRUG; Name: (LMW) Heparin + Vitamin K Antagonist; Assigned to Arm(s): Arm 4
B: Arm Label: BAY59-7939; Type: EXPERIMENTAL; Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939) | Arm Label: Standard of Care; Type: EXPERIMENTAL; Interventions: Drug: Standard of Care | Intervention Type: DRUG; Name: Rivaroxaban (Xarelto, BAY59-7939); Assigned to Arm(s): BAY59-7939 | Intervention Type: DRUG; Name: Rivaroxaban (Xarelto, BAY59-7939); Assigned to Arm(s): BAY59-7939 | Intervention Type: DRUG; Name: Standard of Care; Assigned to Arm(s): Standard of Care
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: dabigatran etexilate 150 mg BID; Type: EXPERIMENTAL; Interventions: Drug: dabigatran etexilate 150 mg twice daily (BID) | Arm Label: matching placebo twice daily (BID); Type: PLACEBO_COMPARATOR; Interventions: Drug: matching placebo twice daily (BID) | Intervention Type: DRUG; Name: dabigatran etexilate 150 mg twice daily (BID); Assigned to Arm(s): dabigatran etexilate 150 mg BID | Intervention Type: DRUG; Name: matching placebo twice daily (BID); Assigned to Arm(s): matching placebo twice daily (BID)

Answer: C