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Swiss Intravenous and Intra-arterial Thrombolysis for Treatment of Acute Ischemic Stroke Registry (SWISS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital Inselspital, Berne
Sponsor:
Collaborators:
Swiss Heart Foundation
University of Zurich
University Hospital, Basel, Switzerland
University Hospital, Geneva
University of Lausanne Hospitals
Kantonsspital Aarau
Cantonal Hospital of St. Gallen
Triemli Hospital
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00811538
First received: December 18, 2008
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

The clinical and radiological data of patients with an acute ischemic stroke treated with intravenous thrombolysis (IVT) or intraarterial thrombolysis (IAT) in a Swiss stroke unit are assessed in a Swiss Multicenter Thrombolysis Registry. Like in clinical routine, a clinical evaluation takes place in a 3-months follow-up. Furthermore quality of life is assessed with a standardized questionnaire. The aim of the registry is to compare the safety and efficacy of IVT and IAT in patients with acute ischemic stroke. The registry also helps to improve in-hospital-management of stroke patients.


Condition Intervention
Ischemic Stroke
Procedure: Intravenous Thrombolysis
Procedure: Intraarterial Thrombolysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Swiss Intravenous and Intra-arterial Thrombolysis for Treatment of Acute Ischemic Stroke Registry (SWISS)

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • overall frequency of favourable clinical outcome (modified Rankin Scale 0 to 2), and unfavourable clinical outcome or death (modified Rankin Scale 3 to 6) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • subgroup analyses will be performed stratified by NIHSS score [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Excellent functional clinical outcome (modified Rankin Scale 0 or 1) and quality of life (measured by EuroQol and Stroke specific Quality of Life Scale) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • All causes of mortality [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
  • Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS) during the first 24 hours after thrombolysis. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Complete or partial recanalization of the occluded artery (TIMI grade 2 or 3) assessed by CTA or MRA. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Symptomatic intracranial haemorrhages up to 24 hours after thrombolysis defined as homogeneous areas of haemorrhage, with or without mass effect or intraventricular extension with neurological deterioration [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1368
Study Start Date: December 2007
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 1 (Liv*)
i.v. thrombolysis with rtPA
Procedure: Intravenous Thrombolysis
i.V. thrombolysis with rtPa
2 (L*)
intraarterial thrombolysis
Procedure: Intraarterial Thrombolysis
Endovascular treatment with i.a. Urokinase or i.a. rtPA or mechanical recanalization techniques

Detailed Description:

Background: Intravenous thrombolysis (IVT) and intra-arterial thrombolysis (IAT) have been shown to be effective treatments for acute stroke in controlled randomized trials and meta-analyses. However, prospective studies comparing IVT and IAT have not been performed, and it is not known which patients benefit more from IVT or IAT. Non-invasive neurovascular imaging techniques such as magnetic resonance angiography (MRA) or computed tomography angiography (CTA) have the potential to improve patient selection for the optimal mode of thrombolytic therapy and provide data of pre-treatment neurovascular findings of patients treated with IVT. IAT series have identified several prognostic factors for favourable or poor outcome predictors such as vessel recanalization, location of the vascular occlusion or NIHSS at admission. Additional studies have shown that recanalization rates in patients with central ves-sel occlusions such as middle cerebral artery (MCA) main stem or MCA main branch or basilar artery (BA) is higher when treated with IAT compared to IVT. Therefore we hypothesize that IAT might be more efficacious in these patients.

Objective: Prospective observational multicenter registry with the following aims: To compare the safety and efficacy of IAT and IVT in patients with acute ischemic stroke. To improve safety of IAT and IVT by monitoring the in-hospital management.

Methods: Consecutive patients with acute ischemic stroke who are treated with IVT or IAT within 6 hours of symptom onset in a Swiss stroke unit will be eligible for this registry. Patients are given either intravenous rt-PA or receive IAT such as intra-arterial urokinase, intra-arterial rt-PA or mechanical endovascular recanalization techniques. Patient involvement in the registry shall not influence any treatment decision. Patients will undergo a complete diagnostic work up including a clinical neurological examination using the National Institutes of Health Stroke Scale (NIHSS) score on admission, laboratory examination, brain and neurovascular imaging, echocardiography, 24-hours ECG to determine stroke etiology using the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria. The treating physician will initiate secondary prevention of stroke as soon as possible. All patients will be examined by CT and CTA or MRI and MRA on day 1 and in any case of clinical deterioration to exclude intracranial haemorrhage and to assess recanalization of the occluded vessel (using the thrombolysis in myocardial infarction (TIMI) grading system). Clinical outcome will be evaluated on day 1 and at 3 months using the National Institute of Health Stroke Scale (NIHSS) score, modified Rankin Scale score (mRS), Barthel Index (BI), and assessing adverse events and quality of life. The proportion of patients with favourable outcome (mRS 0 to 2) at 3 months after IVT and IAT will serve as the primary outcome measure. In addition, subgroup analyses will be performed stratified by NIHSS, location of vessel occlusion, time to hospital admission and time to treatment. Secondary outcome measures will include quality of life and the proportion of patients with an excellent outcome (mRS 0 or 1) at 3 months, BI 75 to 100 at 3 months, mortality at 3 months, rapid neurological improvement during the first 24 hours, complete or partial recanalization, and symptomatic intracranial haemorrhage.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with acute ischemic stroke treated with intravenous or intra-arterial thrombolysis in a Swiss Stroke Unit.

Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Intracranial arterial occlusion confirmed by conventional angiography, MRA or CTA
  • National Institute of health Stroke Scale (NIHSS) score ≥ 4 or isolated aphasia or hemianopia
  • Time to treatment < 6 hours

Exclusion Criteria

  • Intracranial haemorrhage on CT scn or MRI
  • History of intracranial haemorrhage or subarachnoid haemorrhage
  • Platelet count < 100'000
  • International normalized ration (INR) > 1.5
  • Partial thromboplastin time (PTT) > 1.5 times the normal value
  • Known hereditary of acquired haemorrhagic diathesis
  • Pre-existing neurological deficit (mRS>2)
  • Previous stroke that might interfere with the neurological assessment (mRS >2)
  • Active gastric ulcer
  • Major trauma within the preceding 3 months
  • Major surgery within the past 4 weeks
  • Childbirth within the previous 4 weeks
  • Pregnancy
  • Uncontrolled hypertension (>185/10 on repeated measures despite antihypertensive medication)
  • Severe systemic disease with poor prognosis (e.g. cancer, severe heart failure)
  • Intracranial neoplasm
  • Combined IVT and IAT
  • Combined Intravenous and Ultrasound Thrombolysis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811538

Contacts
Contact: Marcel Arnold, MD, Prof. +41 31 632 33 32 marcel.arnold@insel.ch

Locations
Switzerland
Dep. of Neurology, Bern University Hospital Recruiting
Bern, Switzerland, 3010
Contact: Marcel Arnold, MD, PD    +41 31 632 33 32    marcel.arnold@insel.ch   
Contact: Heinrich P Mattle, Prof.    41 31 632 33 32    heinrich.mattle@insel.ch   
Sub-Investigator: Aekaterini Galimanis, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Swiss Heart Foundation
University of Zurich
University Hospital, Basel, Switzerland
University Hospital, Geneva
University of Lausanne Hospitals
Kantonsspital Aarau
Cantonal Hospital of St. Gallen
Triemli Hospital
Investigators
Principal Investigator: Marcel Arnold Dep. of Neurology, Bern University Hospital, Switzerland
Principal Investigator: Krassen Nedeltechev, MD Dep. of Neurology, Bern University Hospital, Switzerland
  More Information

No publications provided

Responsible Party: PD Dr. Marcel Arnold, Oberarzt, Dep. of Neurology, Bern University Hospital
ClinicalTrials.gov Identifier: NCT00811538     History of Changes
Other Study ID Numbers: 233/07, 1446, KEK 233/07
Study First Received: December 18, 2008
Last Updated: September 25, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
ischemic stroke
endovascular treatment
Thrombolysis
outcome

Additional relevant MeSH terms:
Cerebral Infarction
Ischemia
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014