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Question 1
Which dabigatran dose/s were evaluated in the RE-LY® trial?

a) 110 mg BD

b) 150 mg BD

c) 110 mg BD and 150 mg BD

d) 110 mg OD and 150 mg OD

Question 2
Which of the following were inclusion criteria for the RE-LY® trial?

a) Atrial fibrillation (AF) with risk of stroke

b) AF with valvular disease

c) AF with increased risk of haemorrhage

d) All of the above

Question 3
What was the comparator or control in the RE-LY® trial?

a) Rivaroxaban

b) Apixaban

c) Warfarin

d) None of the above

Question 4
How many patients were in each of the Dabigatran groups (rounded off)?

a) 8000

b) 6000

c) 2000

d) 1000

Question 5
What was the therapeutic INR in the Warfarin group?

a) 1-2

b) 2.5-3.5

c) 1.5-2.5

d) 2-3

Question 6
What was the TTR in the Warfarin group?

a) 50 %

b) 57 %

c) 64 %

d) 70 %

Question 7
What was the primary efficacy endpoint of the RE-LY® trial?

a) Stroke

b) Systemic embolism

c) Intracranial haemorrhage

d) Combination of stroke and systemic embolism

Question 8
What was the primary safety endpoint of the RE-LY® trial?

a) Stroke

b) Systemic embolism

c) Major bleeding

d) Vascular mortality

Question 9
What was the follow-up period for the RE-LY® trial?

a) 1 year

b) 2 years

c) 3 years

d) 5 years

Question 10
Why is data from the RE-LY® trial considered to be more robust than data from ROCKET-AF and ARISTOTLE?

a) RE-LY® compared two equally randomised doses of Dabigatran which yielded more dosing and safety information

b) The Dabigatran 150 mg group had more patients which yielded more dosing and safety information

c) The Dabigatran 110 mg group had more patients which yielded more dosing and safety information

d) The follow-up period was longer

Question 11
In the ROCKET-AF study, the lower Rivaroxaban dose was given to:

a) Minority subgroup

b) Patients with prespecified conditions

c) 20 % of patients

d) All of the above

Question 12
What percentage of patients in ARISTOTLE study received the lower Apixaban dose?

a) 20 %

b) 50 %

c) 4.7 %

d) 15

Question 13
In the RE-LY® study, the lower Dabigatran dose was given to:

a) All eligible patients in a 1:1 randomised fashion

b) 50 % of patients

c) Minority subgroup of patients with prespecified conditions

d) a and b

Question 14
In the RE-LY® trial, which of the following endpoints favoured Dabigatran vs. Warfarin?

a) Stroke/systemic embolism

b) Major bleeding

c) Intracranial haemorrhage

d) All of the above

Question 15
In the RE-LY® trial, which one of the following endpoints was significantly in favour of both doses of Dabigatran vs. Warfarin?

a) Stroke/systemic embolism

b) Major bleeding

c) Intracranial haemorrhage

d) Vascular mortality

Question 16
In the RE-LY® trial, which one of the following endpoints was significantly increased only for Dabigatran 150 mg BD vs. warfarin?

a) Major GI bleeding

b) Stroke/systemic embolism

c) Major bleeding

d) Intracranial haemorrhage