Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention
Brief Summary: The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.


Options:
A: Arm Label: Rivaroxaban 2.5 mg bid; Type: EXPERIMENTAL; Interventions: Drug: Rivaroxaban 2.5 mg, Drug: Standard of care | Arm Label: Rivaroxaban 5 mg bid; Type: EXPERIMENTAL; Interventions: Drug: Rivaroxaban 5 mg, Drug: Standard of care | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Standard of care | Intervention Type: DRUG; Name: Rivaroxaban 2.5 mg; Assigned to Arm(s): Rivaroxaban 2.5 mg bid | Intervention Type: DRUG; Name: Rivaroxaban 5 mg; Assigned to Arm(s): Rivaroxaban 5 mg bid | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Standard of care; Assigned to Arm(s): Placebo, Rivaroxaban 2.5 mg bid, Rivaroxaban 5 mg bid
B: 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)
C: Arm Label: Prasugrel; Type: EXPERIMENTAL; Interventions: Drug: Prasugrel | Arm Label: Clopidogrel; Type: ACTIVE_COMPARATOR; Interventions: Drug: Clopidogrel | Intervention Type: DRUG; Name: Prasugrel; Assigned to Arm(s): Prasugrel | Intervention Type: DRUG; Name: Clopidogrel; Assigned to Arm(s): Clopidogrel
D: Arm Label: Apixaban; Type: ACTIVE_COMPARATOR; Interventions: Drug: Apixaban | Arm Label: Vitamin K Antagonist; Type: ACTIVE_COMPARATOR; Interventions: Drug: vitamin K antagonist | Arm Label: Acetylsalicylic acid film coated tablet; Type: PLACEBO_COMPARATOR; Interventions: Drug: Acetylsalicylic acid | Arm Label: Placebo matching Acetylsalicylic acid film coated tablet; Type: PLACEBO_COMPARATOR; Interventions: Other: Acetylsalicylic acid placebo | Intervention Type: DRUG; Name: Apixaban; Assigned to Arm(s): Apixaban | Intervention Type: DRUG; Name: vitamin K antagonist; Assigned to Arm(s): Vitamin K Antagonist | Intervention Type: DRUG; Name: Acetylsalicylic acid; Assigned to Arm(s): Acetylsalicylic acid film coated tablet | Intervention Type: OTHER; Name: Acetylsalicylic acid placebo; Assigned to Arm(s): Placebo matching Acetylsalicylic acid film coated tablet

Answer: D