The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03494920




Registration number
NCT03494920
Ethics application status
Date submitted
4/04/2018
Date registered
4/04/2018
Date last updated
29/04/2018

Titles & IDs
Public title
DIRECT-SAFE: A Randomized Controlled Trial of DIRECT Endovascular Clot Retrieval Versus Standard Bridging Thrombolysis With Endovascular Clot Retrieval
Scientific title
DIRECT-SAFE: A Randomized Controlled Trial of DIRECT Endovascular Clot Retrieval Versus Standard Bridging Thrombolysis With Endovascular Clot Retrieval Within 4.5 Hours of Stroke Onset
Secondary ID [1] 0 0
NTA1601
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Direct endovascular clot retrieval
Other interventions - Bridging thrombolysis followed by ECR

Other: Direct endovascular clot retrieval - Endovascular clot retrieval (ECR) within 4.5 hours stroke

Other: Bridging thrombolysis followed by ECR - Intravenous tPA (at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour) followed by ECR


Other interventions: Direct endovascular clot retrieval
Direct endovascular clot retrieval within 4.5 hours of stroke onset

Other interventions: Bridging thrombolysis followed by ECR
Bridging thrombolysis followed by ECR within 4.5 hours of stroke onset

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Modified Rankin Scale (mRS)- ordinal analysis - Modified Rankin Scale (mRS) 0-2 or no change from baseline
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
modified Rankin Scale (mRS)- ordinal analysis - mRS 0-1 or no change from baseline
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Death - Death due to any cause
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Angiographic reperfusion - Proportion of patients with good angiographic reperfusion (mTICI 2b-3)
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
Symptomatic intracranial haemorrhage (sICH) - Proportion of patients with sICH
Timepoint [4] 0 0
24 hours

Eligibility
Key inclusion criteria
1. Patients presenting with acute ischemic stroke eligible using standard criteria to
receive IV thrombolysis within 4.5 hours of stroke onset

2. Patient's age is =18 years

3. Intra-arterial clot retrieval treatment can commence (groin puncture) within 6 hours
of stroke onset.

4. Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Intracranial hemorrhage (ICH) identified by CT or MRI

2. Rapidly improving symptoms at the discretion of the investigator

3. Pre-stroke mRS score of = 4 (indicating previous disability)

4. Hypodensity in >1/3 MCA territory on non-contrast CT

5. Contra indication to imaging with contrast agents

6. Any terminal illness such that patient would not be expected to survive more than 1
year

7. Any condition that, in the judgment of the investigator could impose hazards to the
patient if study therapy is initiated or affect the participation of the patient in
the study.

8. Pregnant women

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 0 0
Royal Brisbane & Women's Hospital - Brisbane
Recruitment hospital [6] 0 0
Gold Coast University Hospital - Gold Coast
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2305 - New Lambton
Recruitment postcode(s) [4] 0 0
2605 - St Leonards
Recruitment postcode(s) [5] 0 0
- Brisbane
Recruitment postcode(s) [6] 0 0
- Gold Coast
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Neuroscience Trials Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Florey Institute of Neuroscience and Mental Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The study will be a multicentre, prospective, randomized, open label, blinded endpoint
(PROBE) phase 3 trial (2 arm with 1:1 randomization) in ischemic stroke patients within 4.5
hours of stroke onset. Randomised patients will be stratified for site of baseline arterial
occlusion into one of three groups: 1. internal carotid artery (ICA) 2. middle cerebral
artery (MCA) 3. basilar artery (BA). Patients will be randomised to either bridging
intravenous thrombolysis with endovascular clot retrieval (ECR), or direct endovascular clot
retrieval.
Trial website
https://clinicaltrials.gov/show/NCT03494920
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Mitchell, MD
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bernard Yan, MD
Address 0 0
Country 0 0
Phone 0 0
039349 2477
Fax 0 0
Email 0 0
bernard.yan@mh.org.au
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable