Stroke Trials

 

Year

Journal

Trial type

Key outcomes

Patient population

Intervention

Comparator

Outcome - Primary

Outcome secondary

 

INSPIRES

2023

NEJM

RCT

DAPT more effective than aspirin even if started out to 72hours post event

Mild stroke and high risk TIA

 

Within 72 hours

 

China

 

DAPT

Aspirin

New stroke 7.3% vs 9.2% HR 0.79

Bleeding 0.9% vs 0.4%

This is a similar trial and similar result to CHANCE and

The main difference is that this trial allowed starting DAPT out to 72hours (vs 24hours).

CASSISS

2022

JAMA

328:534

RCT

Stenting not effective in ICAD

Patients With Symptomatic Intracranial Stenosis

Stenting (+ medical therapy)

Medical therapy

No difference in stroke of death within 30 days

No difference in stroke in the qualifying artery territory beyond 30 days through 1 year.

 

BAOCHE

2022

NEJM

387

RCT

ECR effective in basilar artery stroke out to 24hours

Stroke due to basilar-artery occlusion

 

Presented at 6 to 24 hours

ECR

Medical Care

Higher percentage with good functional status at 90 days

Significant rate of procedural complications and more cerebral haemorrhages.

 

ATTENTION

2022

NEJM

387:1361

RCT

ECR effective in basilar artery stroke out to 12hours

Stroke due to basilar-artery occlusion

 

Presented up to 12 hours

ECR

Medical care

Better functional outcomes at 90 days

Significant with procedural complications and intracerebral haemorrhage

 

BASICS

2021

NEJM

384:1910

RCT

ECR not effective in basilar artery stroke

Stroke due to basilar-artery occlusion

 

ECR

Medical Care

No difference

 

 

 

Year

Journal

Trial type

Key outcomes

Patient population

Intervention

Comparator

Outcome - Primary

Outcome secondary

 

 

 

 

 

 

 

 

 

 

 

 

TREAT-CAD

2021

Lancet Neurology

RCT

Aspirin = Warfarin for cervical artery dissection

Symptomatic (stroke or local symptoms) cervical artery dissection

Warfarin (or phenprocoumon)

 

Pts: 91

Aspirin

 

 

Pts: 82

 

New stroke (clinical or MRI) at 90days

 

Could not prove non-inferiority of aspirin

 

(although there was an absolute increase of stroke in aspirin group ~7%) 

No difference in final mRS scores

Subsequent post-hoc analysis study suggested benefit of warfarin in some subgroups

Stroke despite DOAC

2023

Neurology

Observational

 

Stroke while taking DOAC

Change DOAC

 

Change to Warfarin

 

Add antiplatelet

Continue DOAC

 

Continue DOAC

 

Continue DOAC

Increased stroke

 

Increased stroke

 

No difference

 

Association of Alternative Anticoagulation Strategies and Outcomes in Patients With Ischemic Stroke While Taking a Direct Oral Anticoagulant

Yiu Ming Bonaventure Ip, Kui Kai Lau, Ho Ko, Lucas Lau, Alan Yao, Grace Lai-Hung Wong, Terry Cheuk-Fung Yip, Xinyi Leng, Howard Chan, Helen Chan, Vincent Mok, Yannie O.Y. Soo, David Seiffge, Thomas W Leung

Neurology May 2023, 10

 

Stroke despite DOAC or warfarin

2022

JNNP

Observational

 

Stroke despite anticoagulation.

 

Warfarin or DOAC

Change warfarin to DOAC

 

Different DOAC

 

Add antiplatelet

Advantage.

Changing

 

 

No advantage

 

Worse outcomes.

 

Aetiology, secondary prevention strategies and outcomes of ischaemic stroke despite oral anticoagulant therapy in patients with atrial fibrillation

SELECT2

2023

NEJM

RCT

ECR was superior to medical management on mRS outcomes. 

 

Stroke in last 24hours with large core

 

ASPECTS 3-5

Or

Core >50ml on CTP

 

 

USA, Australia, NZ

 

 

 

Primary outcome:

Median mRS 4 vs 5

Secondary outcomes:

mRS 0-2: 20.3% vs 7.0%

 

sICH 0.6% vs 1.1%

 

 

ANGEL-ASPECT

2023

NEJM

RCT

Primary outcome:

Median mRS 4 vs 4

Secondary outcomes:

mRS 0-2: 30% vs 11.6%

mRS 0-3: 47% vs 33.3%

 

sICH 6.1% vs 2.7%

ECR for acute ischaemic stroke with large core

 

Stroke in 24 hours

LVO M1 or ICA

 

Stroke in 24 hours

ASPECTS 3-5

OR

Stroke in 24 hours

ASPECTS 0-2 and Core70-100ml

OR

Stroke 6-24hours:

ASPECTS >5 and Core 70-100ml

 

China

Age 18-80 Avg 67

 

 

 

In patients with ischaemic stroke in last 24hours and large core (evidenced by low ASPECTS score or large infarct core on CTP) ECR was superior to medical management on mRS outcomes.  There was a higher rate of sICH in ECR group.

 

 

ANNEXA-I

2024

NEJM

RCT

In patients with ICH taking factor Xa inhibitor given andexxa - Haematoma volume was reduced however disability was no different and there were more thrombotic events.

 

ICH in patient taking factor Xa inhibitor

Andexxa high dose or low dose

 

Placebo

Primary outcomes:

Haematoma expansion <35% - 67% vs 53%

NIHSS fall <7 – 87% vs 83%

Thrombotic events 10.3% vs 5.6%

Death 27.8% vs 25.5%