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Ischemic StrokeSITS OpenNCT02326428

SITS (Safe Implementation of Treatments in Stroke) Open Artery by Thrombectomy in Acute Occlusive Stroke Study

A study testing Stent retriever endovascular device for thrombectomy and Intravenous thrombolysis by alteplase (Actilyse) (optional) in people with Ischemic Stroke, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Ischemic stroke, i.e. irreversible damage of a part of the patient's brain, is caused by the formation of blood clot in the major vessel which gives blood supply to a certain part of the brain. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
Stent retriever endovascular device for thrombectomy and Intravenous thrombolysis by alteplase (Actilyse) (optional)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
341 participants
Where
1 siteSweden
Study dates
Mar 2014to Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with acute stroke after exclusion of intracranial haemorrhage on CT/MRI scan.
  • Confirmed diagnosis on CTA of persisting occlusion of the terminal Internal Carotid Artery (Car-T), proximal Middle Cerebral Artery (MCA, M1), proximal part of the insular segment of MCA (M2), proximal part of the anterior cerebral artery (A1), Basilar Artery (BA) or proximal part of the posterior cerebral artery (P1), consistent with the clinical symptoms. For inclusion in the study, CTA must not be performed later than 15 minutes after IVT start if given. For patients not treated with IVT, CTA should preferably be performed within 15 minutes of completion of the non-contrast CT but must be performed within 6 hours after stroke onset.
  • Eligible patients for IVT are treated according to clinical guidelines (Attachment 1), and IVT, if given, initiated within 4.5 h.
  • Initiation of thrombectomy is recommended within 6 hours after stroke onset but must be performed within to 8 hours if thrombectomy would still be of benefit for the patient as judged by the investigator.
  • Baseline NIHSS Score at initiation of IVT is recommended between 7 and 25 for anterior circulation stroke and ≥7 without upper limit for posterior circulation stroke (baseline NIHSS score should be assessed by an NIHSS-certified physician), but patients may also be included beyond these scores if thrombectomy would still be of benefit for the patient as judged by the investigator.
  • Age ≥18years.
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  • Anticipated life expectancy of at least 6 months.
  • Patient or legal representative is competent to make a decision and has provided informed consent with regard to participation in the study, retrieval and storage of data and follow up procedures.
  • Initiation of endovascular procedure (DSA/TBY, defined as start with groin puncture) within 2 hours from the start of IVT, or after CTA if IVT is not given (for TBY arm patients).

Who cannot join

  • Known significant pre-stroke disability (mRS ≥2).
  • Extended early ischemic changes for basilar artery occlusion, according to the judgment of treating physician based on routine clinical practice of the hospital; if technical possibility exists, early irreversible ischemic changes may be confirmed by pc-ASPECTS score < 8 on CTASI (2) or extensive DWI lesion on pre-treatment MRI.
  • Known pregnancy.
  • Participation in any other investigational drug or device study, currently or in the previous 30 days.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska University Hospital

    Stockholm, 17176

Other trials in Sweden

About this study

Official title: An Open, Prospective, Blinded Evaluation, International, Multicentre, Controlled Study of Safety and Efficacy of Thrombectomy and Standard Stroke Care in Clinical Routine Treatment of Acute Occlusive Stroke Compared to Standard Stroke Care Only

Ischemic stroke, i.e. irreversible damage of a part of the patient's brain, is caused by the formation of blood clot in the major vessel which gives blood supply to a certain part of the brain. At early time, within the first 4,5 hours, the conventional treatment is to try to dissolve this blood clot with a medication ("thrombolytic drug") which is administered to the blood through the needle in the vein. If the clot still remains there, additional treatment is possible - going directly to the clot via artery and taking it out with a special device. Patients may be included even if they are not treated with intravenous thrombolysis because of contraindication or other reasons. The purpose of the present study is to evaluate the benefit and safety efficacy of thrombectomy and standard stroke care in clinical routine treatment of acute occlusive stroke compared to standard stroke care only.

Conditions
Ischemic Stroke
Being tested
Stent retriever endovascular device for thrombectomy, Intravenous thrombolysis by alteplase (Actilyse) (optional)
Keywords
Stroke, Cerebrovascular Accident, Brain ischemia, Intravenous thrombolysis, Stroke thrombectomy, Stent-retriever
Medical subject headings
Ischemic Stroke, Stroke, Brain Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stent retriever endovascular device for thrombectomyDevice

    Also called Mechanical thrombectomy in ischemic stroke

    Thrombectomy by selected stent retrievers (TREVO, Solitaire, pREset, in special cases all stent retrievers) as additional therapy in major artery occlusion in patients fulfilling criteria for and receiving intravenous thrombolysis

  • Intravenous thrombolysis by alteplase (Actilyse) (optional)Drug

    Also called Stroke thrombolysis

    Stroke thrombolysis with Alteplase (Boeringer-Ingelheim, ATC-code B01AD02; a fibrinolytic drug) according to conventional guidelines (0.9 mg/kg, not exceeding 90 mg, given intravenously)

Study groups in NCT02326428
Study groupRoleWhat they receive
ThrombectomyExperimentalThrombectomy arm consists of patients undergoing thrombectomy according to accepted critera in the judgement of investigator. Patients may be included even if they are not treated with intravenous thrombolysis because of contraindication or other reasons.
Receives: Device: Stent retriever endovascular device for thrombectomy; Drug: Intravenous thrombolysis by alteplase (Actilyse) (optional)
ControlActive comparatorControl arm patients are treated with standard stroke care including IVT but do not receive Thrombectomy. Control arm consists of patients fulfilling criteria for thrombectomy according to accepted critera in the judgement of investigator. Patients may be included even if they are not treated with intravenous thrombolysis because of contraindication or other reason.
Receives: Drug: Intravenous thrombolysis by alteplase (Actilyse) (optional)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Categorical shift in modified Rankin Scale score at 3 months

    Categorical shift towards better stroke outcome as reflected by lower, i.e. better, Rankin Scale scores over the range of the scale in active compared to control group.

    Measured: 90 (range 76-104) days from stroke onset

Secondary outcomes (15)

  1. Functional independence at 3 months after stroke onset

    Proportion of patients with functional independence (modified Rankin Scale, mRS, score 0-2) at 3 months after stroke onset

    Measured: 90 (76-104) days after stroke onset

  2. Excellent recovery at 3 months

    Proportion of patients with excellent outcome (mRS score 0-1) at 3 months

    Measured: 90 (76-104) days after stroke onset

  3. Length of in-hospital stay

    Days to discharge from in-hospital ward to home/secondary care for survivors in thrombectomy vs. control

    Measured: 90 (76-104) days after stroke onset

  4. Home time stay

    Number of days the patient stayed at home or at relative's stay within the first 3 months after stroke onset, in thrombectomy vs. control

    Measured: 90 (76-104) days after stroke onset

  5. Recurrent stroke within 3 months

    Measured: 90 (76-104) days after stroke onset

  6. Recanalisation of the occluded artery for thrombectomy treated population

    Recanalisation of the occluded artery for thrombectomy treated population, defined as at least TICI 2b flow in the treated territory after procedure

    Measured: 6h

  7. Time to revascularisation

    Time from stroke onset to revascularisation to any TICI (Thrombolysis in Cerebral Infarction) grade (2b-3 by core lab evaluation) for the actively treated population

    Measured: 6h

  8. Recanalisation of the occluded artery at 24h computerized tomography angiography /contrast-enhanced magnetic resonance angiography

    Defined as AOL 2-3

    Measured: 22-36h

  9. Proportion of patients with recanalisation before thrombectomy

    Defined as AOL 2-3

    Measured: 6h

  10. Reduction of infarct size

    Reduction in infarct size (thrombectomy vs. control) at 22-36 hours

    Measured: 22-36h

  11. Neurological and functional improvement in relation to thrombus length

    Neurological improvement (difference in National Institute of Health Stroke Scale from baseline to 12h, to 24h and to 7D after initiation of intravenous thrombolysis, or discharge if earlier), and functional outcome at 3 months in relation to recanalisation status and thrombus length (mm)

    Measured: 90 (76-104) days

  12. All-cause mortality at 3 months

    Measured: 90 (76-104) days

  13. Neurological death within 7 days post treatment

    Measured: 7 days

  14. Distal embolism/reocclusion demonstrated by follow-up computerized tomography angiography /contrast-enhanced magnetic resonance angiography

    Distal embolism/reocclusion will be evaluated by DSA immediately following the endovascular intervention and at the 22-36 hour follow up CT and CTA scans. The proportion of patients with recanalisation of the target occlusion and distal enbolism/reocclusion will be calculated.

    Measured: 22-36h

  15. Embolism into new territories (ENT)

    Measured: 22-36h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionJan 2018
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
341 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02326428
Sponsor's protocol ID
SITS Open
Acronym
SITS Open
Status last verified
Mar 2018
First submitted
21 May 2014
Last updated
15 Mar 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Ahmed N, Lees KR, von Kummer R, Holmin S, Escudero-Martinez I, Bottai M, Jansen O, Wahlgren N; Collaborators. The SITS Open Study: A Prospective, Open Label Blinded Evaluation Study of Thrombectomy in Clinical Practice. Stroke. 2021 Mar;52(3):792-801. doi: 10.1161/STROKEAHA.120.031031. Epub 2021 Feb 10.

    PubMed 33563015

Questions about this trial

What is this clinical trial studying?

A study testing Stent retriever endovascular device for thrombectomy and Intravenous thrombolysis by alteplase (Actilyse) (optional) in people with Ischemic Stroke, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Categorical shift in modified Rankin Scale score at 3 months (time frame: 90 (range 76-104) days from stroke onset). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02326428, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.

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