Escitalopram Treatment In Acute Stroke (ESTIAS)

This study has been withdrawn prior to enrollment.
(Study medication could not be supplied. An alternative project will be conducted)
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01561092
First received: March 20, 2012
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Stroke
Drug: Escitalopram
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Escitalopram Treatment in Acute Stroke and the Role of SERT Genotype in Stroke

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • New vascular events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death of any cause [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Myocardial Infarction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Re-stroke [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Motor function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Fugl-Meyer Motor score is performed

  • White Matter lesions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluated on MRI

  • Bleeding complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Combined vascular death [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cognitive abilities [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    SDMT and MMSE tests are performed


Enrollment: 0
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01561092

Locations
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
Principal Investigator: Grethe Andersen, Prof. DMSc University Hospital of Aarhus, Neurology Dept.
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01561092     History of Changes
Other Study ID Numbers: 397-2011
Study First Received: March 20, 2012
Last Updated: June 18, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
Stroke
RCT
SSRI
Outcome

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on September 11, 2014