AzTrials
AzTrials

Infarction, Middle Cerebral ArteryPhase 4TURANDOTNCT02016547

Thrombectomy Under Reopro Versus Alteplase to Treat Stoke

A Phase 4 study testing abciximab IV and thrombectomy and alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip) in people with Infarction, Middle Cerebral Artery, run by SOS Attaque Cérébrale at 1 site in France.

Terminated

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

Official record
Search all trials

Trial summary

Intravenous (IV) Alteplase (rt-PA) is the gold standard for brain infarction within 4 h 30 of symptoms onset. Efficacy of this therapy is limited in the setting of large artery occlusions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infarction, Middle Cerebral Artery
What is being tested?
abciximab IV and thrombectomy and alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteFrance
Study dates
Sep 2013to Feb 2015
Phase
Phase 4
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 signs consistent with acute ischemic stroke < 4.5 hours
  • Cerebral infarction and middle cerebral artery occlusion, without any hemorrhage documented by MRI or CT
  • 4 < National Institute of Health Stroke Score (NIHSS) < 25
  • age > 18 years
  • no prestroke functional dependance : modified Rankin score ≤ 2
  • subject or subject's legally authorized representative has signed and dated an Informed Consent Form according to french regulations and ethic committee.

Who cannot join

  • pregnant or lactating female
  • coma (vigilance NIHSS > 1)
  • epilepsy
  • recent history of stroke
  • anticoagulant therapy or International Normalized Ratio (INR) > 1.7 ; heparin therapy within past 24 hours and Temps de Cephaline Activee (TCA) extension
  • previous subarachnoid hemorrhage or clinical presentation suggesting a subarachnoid hemorrhage, even if initial CT or MRI scan are normal
Show all 20Show fewer
  • known hereditary or acquired hemorrhagics diathesis, coagulation factor deficiency
  • uncontrolled hypertension defined as systolic blood pressure ≥ 185 millimeters of mercury (mmHg) or diastolic blood pressure > 110 mmHg at time of admission and time of threat
  • lumbar ar arterial puncture within past 7 days
  • major surgery within past 2 months
  • gastrointestinal hemorrhage or urinary hemorrhage
  • myocardial infarction within past 21 days
  • pericarditis within past 3 months
  • suspicion of bacterial endocarditis within past 3 months
  • previous of aortic dissection
  • baseline lab values : TCA > 40, platelets < 100 000/mm3, glucose < 3 mmol/l or > 22 mmol/l
  • hepatic insufficiency
  • CT or MRI evidence oh hemorrhage
  • CT or MRI evidence of mass effect or intra-cranial tumor
  • CT showing hypodensity or MRI showing hyperdensity involving greater than 1/3 of the middle cerebral artery territory (ASPECT score < 7)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Stroke Center, Bichat Hospital

    Paris, 78018

Other trials in France

About this study

Official title: Thrombectomy Under Reopro Versus Alteplase and Neurologic Deficit Outcome Trial

Intravenous (IV) Alteplase (rt-PA) is the gold standard for brain infarction within 4 h 30 of symptoms onset. Efficacy of this therapy is limited in the setting of large artery occlusions. For middle cerebral artery occlusions (MCA)or internal carotid artery occlusions (ICA), recanalization rates will drop as low as 10%. This element is critical as prognosis is linked to recanalization. Arterial re-occlusions are frequent and may reach 30%, which limits IV thrombolysis efficacy.With the endovascular approach, recanalization rates may reach 90% with last generation devices. A recent meta-analysis has shown that the best candidates for thrombectomy are MCA occlusions. In the coronary literature, endovascular therapy efficacy is increased in association with antiplatelets such as abciximab. The aim of the study was to assess the feasibility of thrombectomy associated with abciximab on revascularisation (TICI score), as well as safety (symptomatic intracranial bleeding), in order to design a clinical trial versus the gold standard for acute ischemic stroke revascularization strategies using IV rt-PA.This is a controlled, pilot study, evaluating feasibility and safety of thrombectomy with abciximab versus IV rt-PA in acute ischemic stroke patients within 4h30 of symptoms onset.

Being tested
abciximab IV and thrombectomy, alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)
Keywords
Stroke, Middle Cerebral Artery, Thrombectomy, Mechanical Thrombolysis, Abciximab
Medical subject headings
Infarction, Middle Cerebral Artery, Stroke

What participants receive

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

  • abciximab IV and thrombectomyProcedure or surgery

  • alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)Drug

Study groups in NCT02016547
Study groupRoleWhat they receive
abciximab IV and thrombectomyExperimentalabciximab IV (0.25mg/kg by IV bolus, following by 0.125μg/kg by 12 hours IV drip) and thrombectomy
Receives: Procedure: abciximab IV and thrombectomy
alteplaseActive comparatoralteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)
Receives: Drug: alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)

What is being measured

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

  1. recanalization rate

    Measured: 24 hours

Secondary outcomes (2)

  1. Symptomatic intracranial bleeding

    Measured: 24 hours

  2. percentage of patients with a favorable outcome

    Measured: 3 months

Timeline

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

  1. First posted20 Dec 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionFeb 2015 (estimated)
  4. Study completionFeb 2015 (estimated)

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02016547
Sponsor's protocol ID
2012-005493-66
Acronym
TURANDOT
Status last verified
Apr 2014
First submitted
16 Dec 2013
Last updated
25 Apr 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing abciximab IV and thrombectomy and alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip) in people with Infarction, Middle Cerebral Artery, run by SOS Attaque Cérébrale at 1 site in France.

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 6 inclusion and 20 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 25 Apr 2014. 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 France. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. 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?

recanalization rate (time frame: 24 hours). 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 NCT02016547.

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 25 Apr 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in