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Table 1 Large randomized controlled trials investigating pharmacological or interventional treatment for stroke prevention after ICH

From: Resumption of oral anticoagulation after spontaneous intracerebral hemorrhage

Trial name

(ClinicalTrials.gov)

Design

Allocation ratio

Study population

Est. sample size (n)

Location

Intervention

Est. primary completion date

Pharmacological treatment

 APACHE-AF (NCT02565693)

Open label

1:1

ICH and AF

100

Netherlands

Apixaban vs antiplatelets or none

January 2021

 ASPIRE (NCT03907046)

Quadruple-blind

1:1

Non-lobar ICH and AF

700

USA

Apixaban vs ASS 81 mg/d

April 2024

 NASPAF-ICH (NCT02998905)

PROBE

1:1

ICH and AF

100

Canada

NOAC vs ASS 81 mg/d

October 2019

 PRESTIGE-AF

Open label

1:1

ICH

662

Europe

NOAC vs antiplatelets or none

November 2022

 SoSTART (NCT03153150)

PROBE

1:1

ICH and AF

800

United Kingdom

OAC vs antiplatelets or none

July 2021

 STATICH (NCT03186729)

PROBE

1:1

ICH and AF or no AF

500

Scandinavia

OAC or antiplatelets vs none

June 2021

Left atrial appendage occlusion (LAAO)

 A3ICH (NCT03243175)

PROBE

1:1:1

ICH and AF

300

France

Apixaban vs LAAO vs antiplatelets or none

December 2022

 Amulet IDE (NCT02879448)

Open label

1:1

High bleeding risk and AF

1878

Worldwide

Amulet LAAO vs WATCHMAN LAAO

February 2020

 ASAP-TOO (NCT02928497)

Open label

2:1

High bleeding risk and AF

888

Belgium, Denmark, USA

LAAO vs antiplatelets or none

December 2023

 CLOSURE-AF (NCT03463317)

Open label

1:1

High bleeding risk and AF

1512

Germany

LAAO vs active comparator (NOAK or VKA)

February 2021

 LAAOS III (NCT01561651)

Quadruple-blind

1:1

Cardiopulmonary bypass surgery and AF

4812

Canada

Surgical LAAO vs best medical treatment

November 2022

 PRAGUE-17 (NCT02426944)

Open label

1:1

History of bleeding and AF

400

Czech Republic

LAAO vs NOAK

May 2018

 STROKECLOSE (NCT02830152)

PROBE

2:1

ICH and AF

750

Sweden

LAAO vs best medical treatment

May 2022

  1. Information based on data from international (US, Asian, European) registries
  2. Abbreviations: AF atrial fibrillation, Est. estimated, ICH inracranial hemorrhage, LAAO left atrial appendage occlusion, PROBE prospective randomized open blinded end-point