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Escitalopram Treatment In Acute Stroke (ESTIAS)

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ClinicalTrials.gov Identifier: NCT01561092
Recruitment Status : Withdrawn (Study medication could not be supplied. An alternative project will be conducted)
First Posted : March 22, 2012
Last Update Posted : June 19, 2012
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Study Description
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Brief Summary:

Growing international scientific evidence has indicated a positive effect of SSRI treatment (serotonin reuptake inhibitors) after stroke, beyond its antidepressant effect. We wish to conduct a prospective randomised double blind placebo-controlled multicenter study of the combined neuroprotective and antithrombotic effects of SSRI treatment after stroke. Deletion of the SERT (serotonin transporter) gene may influence this treatment effect and may in itself be a risk factor for stroke, an aspect we also wish to explore.

Hypotheses:

  1. SSRI treatment commenced in the acute phase of stroke (day 2-5) protects against new thromboembolic events and leads to better rehabilitation.
  2. A specific SERT genotype is associated with an increased risk of first ever stroke.
  3. A specific SERT genotype is associated with a higher risk of post stroke depression.

600 stroke patients will be randomised to either escitalopram or placebo treatment in a 1:1 ratio and genotyped according to SERT polymorphisms. The treatment and follow up period is 6 months. During these 6 months there will be 2 clinical follow up visits, one telephone control and one visit to evaluate compliance regarding medication. Patients who had an MRI as a part of the routine investigations done upon admission (approximately 300 patients) will have a control MRI after 6 months.

Additionally 400 patients, not eligible for participation i the randomised controlled trial, will be genotyped and answer questionnaires after 1 and 6 months.


Condition or disease Intervention/treatment Phase
Stroke Drug: Escitalopram Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Escitalopram Treatment in Acute Stroke and the Role of SERT Genotype in Stroke

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Escitalopram Drug: Escitalopram
5 or 10 mg escitalopram tablets administered orally once daily
Other Names:
  • SSRI
  • Cipralex
Placebo Comparator: Non active drug Drug: Placebo
Tablets


Outcome Measures
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Primary Outcome Measures :
  1. New vascular events [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Death of any cause [ Time Frame: 6 months ]
  2. Myocardial Infarction [ Time Frame: 6 months ]
  3. Re-stroke [ Time Frame: 6 months ]
  4. Motor function [ Time Frame: 6 months ]
    Fugl-Meyer Motor score is performed

  5. White Matter lesions [ Time Frame: 6 months ]
    Evaluated on MRI

  6. Bleeding complications [ Time Frame: 6 months ]
  7. Combined vascular death [ Time Frame: 6 months ]
  8. Cognitive abilities [ Time Frame: 6 months ]
    SDMT and MMSE tests are performed


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First ever ischemic stroke
  • Age 18 years or above

Exclusion Criteria

  • Hemorrhagic stroke
  • Dementia or other neurodegenerative disease
  • Antidepressant treatment within 6 months of admission
  • Acute need for antidepressant treatment
  • Drug abuse or other conditions that may indicate noncompliant behavior
  • Liver failure (increased liver enzyme levels up to or more than 2 times upper limit)
  • Renal failure (GFR under 30)
  • Hyponatremia (S-potassium below 130 mmol/l)
  • Actively bleeding ulcer
  • Fatal stroke or other severe co morbidity that markedly decreases expected life span
  • Prolonged QT interval (QTc above 500 ms)
  • Ongoing treatment with drugs known to prolong the QT interval
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561092


Locations
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Denmark
Neurology Department, Aalborg Hospital
Aalborg, Denmark, 9000
Neurology Department, University Hospital of Aarhus
Aarhus, Denmark, 8000
Neurology Department, Glostrup Hospital
Glostrup, Denmark, 2600
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
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Principal Investigator: Grethe Andersen, Prof. DMSc University Hospital of Aarhus, Neurology Dept.
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01561092     History of Changes
Other Study ID Numbers: 397-2011
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012
Keywords provided by University of Aarhus:
Stroke
RCT
SSRI
Outcome
Additional relevant MeSH terms:
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Dexetimide
Citalopram
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Cholinergic Agents
Stroke
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists