Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication
Brief Summary: The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE.

The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.


Options:
A: Arm Label: Dabigatran etexilate (150mg bid); Type: EXPERIMENTAL; Interventions: Drug: Dabigatran etexilate | Arm Label: Warfarin (INR 2.0-3.0); Type: ACTIVE_COMPARATOR; Interventions: Drug: Warfarin | Intervention Type: DRUG; Name: Warfarin; Assigned to Arm(s): Warfarin (INR 2.0-3.0) | Intervention Type: DRUG; Name: Dabigatran etexilate; Assigned to Arm(s): Dabigatran etexilate (150mg bid)
B: Arm Label: Dabigatran dose 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dabigatran dose 2 | Arm Label: Warfarin; Type: ACTIVE_COMPARATOR; Interventions: Drug: warfarin | Arm Label: Dabigatran dose 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dabigatran dose 1 | Intervention Type: DRUG; Name: warfarin; Assigned to Arm(s): Warfarin | Intervention Type: DRUG; Name: Dabigatran dose 1; Assigned to Arm(s): Dabigatran dose 1 | Intervention Type: DRUG; Name: Dabigatran dose 2; Assigned to Arm(s): Dabigatran dose 2
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; Type: EXPERIMENTAL; Interventions: Drug: dabigatran etexilate | Arm Label: standard of care; Type: ACTIVE_COMPARATOR; Interventions: Drug: standard of care | Intervention Type: DRUG; Name: dabigatran etexilate; Assigned to Arm(s): dabigatran etexilate | Intervention Type: DRUG; Name: standard of care; Assigned to Arm(s): standard of care

Answer: A