Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation (PRESTIGE-AF)
Brief Summary: Atrial fibrillation (AF) is the most common form of irregular heart rhythm. In people with AF, blood clots often form in the heart, which can travel to the brain. Blockage of brain arteries by these clots is a major cause of stroke. This type of stroke is called an ischaemic stroke and approximately 15% of all ischaemic strokes are caused by AF.

People with AF are often prescribed a medication called an anticoagulant, which makes it less likely for blood clots to form and thus can prevent ischaemic strokes. However, anticoagulants also increase the risk of bleeding, so they are not suitable for everyone.

Some people who have AF have had a different type of stroke which is caused by bleeding in the brain, an intracerebral haemorrhage (ICH). These people are at increased risk of suffering both an ischaemic stroke (due to AF) and another ICH. It is not known whether it is best for these people to take an anticoagulant medication or not, as previous research studies did not include this group of people.

PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (PRESTIGE-AF) is a research study on the best stroke prevention in people with atrial fibrillation (AF) who have recently had a bleeding in their brain, (ICH). This is a trial where half of the participants will take an anticoagulant medication, preventing blood clot formation, and half will not receive an anticoagulant. The direct oral anticoagulants (DOACs) that will be used in this trial are all licenced for use in the United Kingdom and within the European Union (EU) to prevent strokes in people with AF. However, the current licence does not extend to use with people who have had an ICH because it has not been tested in this group with a randomised controlled trial. DOACs will be tested in ICH survivors with AF because previous research trials have shown that people are up to 50% less likely to have bleeding complications in the brain with DOACs than with Warfarin (another commonly used anticoagulant).

The aim of PRESTIGE-AF is to answer the question of whether people with ICH and AF should take an anticoagulant medication or if it is better for them to avoid it.


Options:
A: Arm Label: low weight molecular heparin; Type: EXPERIMENTAL; Interventions: Drug: Enoxaparin | Arm Label: standard therapy; Type: PLACEBO_COMPARATOR; Interventions: Other: Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization | Intervention Type: DRUG; Name: Enoxaparin; Assigned to Arm(s): low weight molecular heparin | Intervention Type: OTHER; Name: Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization; Assigned to Arm(s): standard therapy
B: Arm Label: Direct Oral Anticoagulant; Type: EXPERIMENTAL; Interventions: Drug: Apixaban Oral Tablet, Drug: Dabigatran, Drug: Edoxaban Tablets, Drug: Rivaroxaban | Arm Label: No Anticoagulant; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Apixaban Oral Tablet; Assigned to Arm(s): Direct Oral Anticoagulant | Intervention Type: DRUG; Name: Dabigatran; Assigned to Arm(s): Direct Oral Anticoagulant | Intervention Type: DRUG; Name: Edoxaban Tablets; Assigned to Arm(s): Direct Oral Anticoagulant | Intervention Type: DRUG; Name: Rivaroxaban; Assigned to Arm(s): Direct Oral Anticoagulant
C: Arm Label: DU-176b 15 mg group; Type: EXPERIMENTAL; Interventions: Drug: Du-176b | Arm Label: Placebo group; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Du-176b; Assigned to Arm(s): DU-176b 15 mg group | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo group
D: Arm Label: Antithrombotic treatment; Type: EXPERIMENTAL; Interventions: Drug: Antithrombotic Agent | Arm Label: No antithrombotic treatment; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Antithrombotic Agent; Assigned to Arm(s): Antithrombotic treatment

Answer: B