CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 319 enrolled
Drug / intervention
Apixaban Oral Tablet +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03996772
NCT03996772Phase 3Completed

PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation (PRESTIGE-AF)

Imperial College London·interventional·Posted Jun 25, 2019·Updated Jan 13, 2025

In Brief

A Phase 3 clinical trial evaluating Apixaban Oral Tablet, Dabigatran, and 2 other interventions for Atrial Fibrillation and Intracerebral Hemorrhage. Completed, enrolled 319 participants across 64 sites in 6 countries.

Detailed 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.

Study Details

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 25, 2019
Enrollment StartJun 3, 2019
Primary CompletionMay 31, 2024
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 7.0 years ago

Interventions

Apixaban Oral Tabletdrug

Factor Xa Inhibitor

Dabigatrandrug

Direct Thrombin Inhibitor

Edoxaban Tabletsdrug

Factor Xa Inhibitor

Rivaroxabandrug

Factor Xa Inhibitor