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Acute Ischaemic StrokePISTENCT01745692

Pragmatic Ischaemic Stroke Thrombectomy Evaluation

A study testing Mechanical thrombectomy and Intravenous rtPA in people with Acute Ischaemic Stroke, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Ischaemic strokes (those caused by blockage in an artery in the brain caused by a blood clot) can be treated with very early use of clot-busting (thrombolytic) drugs to attempt to restore the blood supply and limit the damage, resulting in an increased proportion of people making a recovery to independence after… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischaemic Stroke
What is being tested?
Mechanical thrombectomy and Intravenous rtPA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteUnited Kingdom
Study dates
Dec 2012to Jul 2015
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

  • Clinical diagnosis of supratentorial acute ischaemic stroke
  • Male or nonpregnant female ≥18 years of age
  • Clinically significant neurological deficit and NIHSS score ≥6.
  • Eligible for IV rtPA according to standard guidelines and able to be commenced on IV treatment <4.5h after symptom onset.
  • Enrolment, randomisation and procedure commencement (groin puncture) possible within 90 minutes of the start of IV rtPA treatment (groin puncture maximum 5.5h after stroke onset).
  • Occlusion of the main middle cerebral artery (MCA) trunk, MCA bifurcation or intracranial internal carotid artery(carotidT, M1 or single proximal M2 branch) demonstrated on CTA, MRA, or DSA.
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  • Interventional device delivery (guide catheter placed beyond aortic arch and angio obtained) can be achieved within 6 hours of onset of the stroke.
  • Consent of patient or representative.
  • Independent prior to the stroke (estimated mRS 02)
  • Expected to be able to be followed up at 3 months

Who cannot join

  • CT evidence of intracranial haemorrhage, or evidence of extensive established hypodensity on CT.
  • Clinical history suggestive of subarachnoid haemorrhage even if CT normal.
  • Known vascular access contraindications e.g. femoral bypass surgery, tight ipsilateral carotid stenosis, unsuitable proximal vascular anatomy likely to render endovascular catheterisation difficult or impossible.
  • Extracranial ICA occlusion or basilar artery occlusion
  • Alternative intracranial pathology potentially responsible for the new symptoms
  • Medical comorbidities which would preclude safe cerebral vessel catheterisation or which are expected to limit life expectancy to <3 months (eg severe cardiac, renal or hepatic failure, significant coagulopathy, metastatic malignancy)
  • Known allergy to radiological contrast

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • NHS Greater Glasgow and Clyde

    Glasgow, G51 4TF

Other trials in United Kingdom

About this study

Official title: A Randomised Controlled Clinical Trial of Adjunctive Mechanical Thrombectomy Compared With Intravenous Thrombolysis in Patients With Acute Ischaemic Stroke Due to an Occluded Major Intracranial Vessel.

Ischaemic strokes (those caused by blockage in an artery in the brain caused by a blood clot) can be treated with very early use of clot-busting (thrombolytic) drugs to attempt to restore the blood supply and limit the damage, resulting in an increased proportion of people making a recovery to independence after stroke. However, drug treatment only succeed in restoring blood flow in a minority of people with clots in the larger arteries (10-25% depending on the size of the blood vessel) and these people also have the most severe strokes and highest risk of death or dependence as a result of the stroke. Current best treatment is therefore least effective in the group with the most severe strokes. Devices that can be fed through the blood vessels to either remove or break up the blood clot in the brain vessels can open this type of large artery blockage. However, using these devices is a highly skilled procedure and it takes some time both to set up the necessary facilities (including anaesthetic, nurses and medical support) and to reach the blockage. The extra time that is required to use these devices may mean that brain tissue is already irreversibly damaged. If so, then an individual patient cannot benefit and indeed may be harmed by opening the artery. There are no completed clinical trials comparing the outcome in people treated with standard stroke treatment and those treated with devices. PISTE is a randomised, controlled trial to test whether additional mechanical thrombectomy device treatment improves functional outcome in patients with large artery occlusion who are given IV thrombolytic drug treatment as standard care.

Being tested
Mechanical thrombectomy, Intravenous rtPA

What participants receive

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

  • Mechanical thrombectomyDevice

  • Intravenous rtPADrug

    Also called alteplase

    All patients receive IV alteplase

Study groups in NCT01745692
Study groupRoleWhat they receive
Intravenous rtPAActive comparatorIV alteplase (rtPA) 0.9mg/kg (10% of dose as bolus followed by 90% as infusion over 1 hour, to a maximum dose of 90mg total) given within 4.5 hours of onset of stroke symptoms
Receives: Drug: Intravenous rtPA
Intravenous rtPA and Mechanical ThrombectomyExperimentalIV alteplase (rtPA) 0.9mg/kg (10% of dose as bolus followed by 90% as infusion over 1 hour, to a maximum dose of 90mg total) given within 4.5 hours of onset of stroke symptoms + additional mechanical thrombectomy procedure to commence within 90 minutes of start of IV rtPA infusion
Receives: Device: Mechanical thrombectomy; Drug: Intravenous rtPA

What is being measured

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

  1. modified Rankin Scale

    The proportion with favourable functional outcome defined as mRS 0-2 at 90 (+/-7) days based on the modified Rankin scale structured interview

    Measured: Day 90 +/-7

Secondary outcomes (10)

  1. modified Rankin Scale

    Full neurological recovery (mRS 0-1 versus 2-6)

    Measured: Day 90+/-7

  2. Mortality

    Measured: Day 90 +/-7

  3. modified Rankin Scale

    Change in distribution of mRS scores adjusted for baseline variables

    Measured: Day 90 +/-7

  4. NIH Stroke Scale (NIHSS)

    Early major neurological improvement of 8 or more points, or return to NIHSS total score of 0 or 1, at 72 hours (or discharge if earlier)

    Measured: 72 hours

  5. Angiographic patency

    Angiographic patency at 22-36 hours (Core lab assessed), using CTA or MRA

    Measured: 22-36 hours

  6. Immediate recanalisation rate

    Immediate (i.e. end of procedure) recanalisation rates in subjects undergoing interventional procedures (core lab assessed).

    Measured: End of procedure

  7. Home Time

    Days spent at home between stroke and day 90

    Measured: Day 90 +/-7

  8. Symptomatic intracranial haemorrhage

    Symptomatic intracranial haemorrhage rates defined as local or remote parenchymal haemorrhage type 2 (PH2 or PHr2 ICH by ECASS 2 definition) on the 22-36 h post-treatment imaging scan, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline, or from the lowest NIHSS value between baseline and 24 h, or leading to death (SITS-MOST definition)

    Measured: 22-26h

  9. Intracranial haemorrhage

    Any intracranial haemorrhage on 22-36h CT or MRI

    Measured: 22-36 hours

  10. Significant extracranial bleeding

    Extracranial bleeding, groin haematoma requiring evacuation / surgery or transfusion

    Measured: Up to day 90

Timeline

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

  1. First posted10 Dec 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionApr 2015
  4. Study completionJul 2015

Why it stopped: IDMC decision - recommended on basis of results from other relevant clinical trials, there were not safety concerns

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01745692
Sponsor's protocol ID
GN11NE257
Other IDs
TSA 2011/06
Acronym
PISTE
Status last verified
Oct 2015
First submitted
30 Nov 2012
Last updated
26 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Heggie R, Wu O, White P, Ford GA, Wardlaw J, Brown MM, Clifton A, Muir KW. Mechanical thrombectomy in patients with acute ischemic stroke: A cost-effectiveness and value of implementation analysis. Int J Stroke. 2020 Oct;15(8):881-898. doi: 10.1177/1747493019879656. Epub 2019 Sep 30.

    PubMed 31564243

  • Muir KW, Ford GA, Messow CM, Ford I, Murray A, Clifton A, Brown MM, Madigan J, Lenthall R, Robertson F, Dixit A, Cloud GC, Wardlaw J, Freeman J, White P; PISTE Investigators. Endovascular therapy for acute ischaemic stroke: the Pragmatic Ischaemic Stroke Thrombectomy Evaluation (PISTE) randomised, controlled trial. J Neurol Neurosurg Psychiatry. 2017 Jan;88(1):38-44. doi: 10.1136/jnnp-2016-314117. Epub 2016 Oct 18.

    PubMed 27756804

  • Hurford R, Tyrrell PJ. Stroke thrombolysis: where are we and where are we going? Clin Med (Lond). 2013 Dec;13 Suppl 6:s20-3. doi: 10.7861/clinmedicine.13-6-s20.

    PubMed 24298176

Questions about this trial

What is this clinical trial studying?

A study testing Mechanical thrombectomy and Intravenous rtPA in people with Acute Ischaemic Stroke, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.

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 10 inclusion and 7 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: stopped early, as of the sponsor's last update on 26 Oct 2015. 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 United Kingdom. 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 was stopped early (reason given: IDMC decision - recommended on basis of results from other relevant clinical trials, there were not safety concerns). Results are not available in the source record.

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?

modified Rankin Scale (time frame: Day 90 +/-7). 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 NCT01745692, which also lists 3 linked publications.

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 26 Oct 2015.

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