NCT00811538

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,476

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2008

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

7.3 years

First QC Date

December 18, 2008

Last Update Submit

April 11, 2016

Conditions

Ischemic Stroke

Keywords

ischemic strokeendovascular treatmentThrombolysisoutcome

Outcome Measures

Primary Outcomes (1)

  • overall frequency of favourable clinical outcome (modified Rankin Scale 0 to 2), and unfavourable clinical outcome or death (modified Rankin Scale 3 to 6)

    Day 90

Secondary Outcomes (6)

  • subgroup analyses will be performed stratified by NIHSS score

    Day 90

  • Excellent functional clinical outcome (modified Rankin Scale 0 or 1) and quality of life (measured by EuroQol and Stroke specific Quality of Life Scale)

    Day 90

  • All causes of mortality

    Day 90

  • Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS) during the first 24 hours after thrombolysis.

    Day 1

  • Complete or partial recanalization of the occluded artery (TIMI grade 2 or 3) assessed by CTA or MRA.

    Day 1

  • +1 more secondary outcomes

Study Arms (2)

1 1 (Liv*)

i.v. thrombolysis with rtPA

Procedure: Intravenous Thrombolysis

2 (L*)

intraarterial thrombolysis

Procedure: Intraarterial Thrombolysis

Interventions

Intravenous ThrombolysisPROCEDURE

i.V. thrombolysis with rtPa

1 1 (Liv*)
Intraarterial ThrombolysisPROCEDURE

Endovascular treatment with i.a. Urokinase or i.a. rtPA or mechanical recanalization techniques

2 (L*)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Neurology, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Marcel Arnold, MD Prof.

    Dep. of Neurology, Bern University Hospital, Switzerland

    PRINCIPAL INVESTIGATOR

  • Krassen Nedeltechev, MD Prof.

    Kantonsspital Aarau, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 18, 2008

First Posted

December 19, 2008

Study Start

December 1, 2007

Primary Completion

March 1, 2015

Study Completion

December 1, 2015

Last Updated

April 13, 2016

Record last verified: 2016-04

Locations

CH(1)