Efficacy and Safety of Actovegin in Post-stroke Cognitive Impairment (PSCI) (ARTEMIDA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01582854
First received: April 20, 2012
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

The aim of this trial is to provide evidence that Actovegin has a symptomatic effect in subjects with post stroke cognitive impairment (PSCI) during a six month treatment period compared to subjects administered placebo. Subjects will receive IV infusions whilst in hospital, and tablets once discharged. Subjects will be followed up for a further six months after their treatment is stopped to explore if the cognitive symptoms of the subjects treated with Actovegin show sustained improvement. The trial will also explore the possible prevention of dementia with Actovegin in patients who have suffered a recent ischaemic stroke, as well as the effect of Actovegin on other stroke outcomes. Safety information on Actovegin will be collected.


Condition Intervention Phase
Post-Stroke Cognitive Impairment (PSCI)
Drug: Actovegin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 12-month, International, Parallel Group, Randomised, Multi-centre, Double-blind, Placebo-controlled Trial to Examine the Effect of Actovegin® Treatment Given First Intravenously and Subsequently Orally Over 6 Months, in Subjects With Post-stroke Cognitive Impairment (PSCI).

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • ADAS-cog+ at 6 months (change from baseline) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Alzheimer's Disease Assessment Scale + Cognitive subscale extended version) (ADAS-cog) measures cognitive performance by combining ratings of 11 items (word recall, word recognition, constructional praxis, orientation, naming objects and fingers, commands, ideational praxis, remembering test instruction, spoken language, word finding and comprehension)


Secondary Outcome Measures:
  • ADAS-cog+ at 3 and 12 months (change from baseline) [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • MoCA at end of infusion period, 3, 6 and 12 months (change from baseline) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]

    Montreal Cognitive Assessment Scale (MoCA) measures a score of ≤ 25 points:

    • 4-9 school years ≤ 23 points,
    • 10-12 years ≤ 24 points
    • >12 years ≤ 25 points

  • ADAS-cog+ responders at time points 3, 6 and 12 months [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Diagnosis of dementia [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Diagnosis of dementia will be evaluated after 6 and 12 months classified according to International Statistical Classification of Diseases and related Health Problems (ICD-10) (Classification of Mental and Behavioural Disorders, Diagnostic Criteria for Research)

  • NIHSS at end of infusion period, 3, 6 and 12 months (relative change from baseline) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    National Institutes of Health Stroke Scale (NIHSS) measures a score between 3 and 18.

  • Barthel Index at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Barthel Index consists of 10 items that measure a person's daily functioning specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder.

  • EuroQol EQ-5D (EQ-5D) at 6 and 12 months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

    The measurement of states of health is crucial in determining the outcomes of health care. The EuroQoL EQ-5D questionnaire was developed as a generic state of health measure and describes states of health in five dimensions: mobility, self care, usual activities, pain or discomfort, and anxiety or depression.

    EQ-5D is a standardised measure of health status. 5 dimensions: mobility, self care, usual activities, pain/discomfort, anxiety/depression.

    each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems


  • Beck Depression Inventory, version II (BDI-II) at 3, 6 and 12 months [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]

    BDI II scale:

    • 0-13 minimal depression
    • 14-19 mild depression
    • 20-28 moderate depression
    • 29-63 severe depression


Enrollment: 500
Study Start Date: June 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Actovegin Drug: Actovegin
  • Actovegin 8mg/mL Solution for Infusion (0.9% NaCl) (250mL / 2000 mg / intravenously (IV) / day) up to 20 days
  • Actovegin 200 mg tablets as 2 tablets 3 times daily from the day after the end of infusions and for the remainder of the 6-month treatment period.
Placebo Comparator: Placebo Drug: Placebo
  • Actovegin placebo Solution for Infusion (0,9% NaCl) (250 mL / IV / day) up to 20 days
  • Actovegin placebo tablets as 2 tablets 3 times daily from the day after the end of infusions and for the remainder of the 6-month treatment period.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Subject has suffered a recent supra-tentorial ischaemic stroke supported by CT scan or MRI findings (in accordance with local practice).
  • Subject is male or female, aged 60 years or above.
  • Subject has a score on the National Institute of Health Stroke Scale (NIHSS) between 3 and 18 (inclusive)
  • Subject is capable of completing the Montreal Cognitive Assessment (MoCA) and has a score of ≤ 25 points with adjustment for level of education (4-9 school years ≤ 23 points, 10-12 years ≤ 24 points, >12 years ≤ 25 points)

Main Exclusion Criteria:

  • Subject has a medical history of dementia
  • Subject has a known medical history of major depression or psychotic disorder
  • Subject is indicated for treatment with thrombolytics or carotid surgery as the current standard of care

Randomisation Criteria

  • Inclusion Criteria
  • Ability to perform ADAS-cog+
  • Exclusion Criteria
  • Clinically there is suspicion of progressive stroke
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582854

Locations
Belarus
Nycomed Investigational Site
Grodno, Belarus
Nycomed Investigational Site
Minsk, Belarus
Nycomed Investigational Site
Vitebsk, Belarus
Kazakhstan
Nycomed Investigational Site
Almaty, Kazakhstan
Russian Federation
Nycomed Investigational Site
Barnaul, Russian Federation
Nycomed Investigational Site
Ekaterinburg, Russian Federation
Nycomed Investigational Site
Irkutsk, Russian Federation
Nycomed Investigational Site
Kazan, Russian Federation
Nycomed Investigational Site
Krasnoyarsk, Russian Federation
Nycomed Investigational Site
Moscow, Russian Federation
Nycomed Investigational Site
Novosibirsk, Russian Federation
Nycomed Investigational Site
Samara, Russian Federation
Nycomed Investigational Site
St. Petersburg, Russian Federation
Nycomed Investigational Site
Tomsk, Russian Federation
Sponsors and Collaborators
Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01582854     History of Changes
Other Study ID Numbers: AV-2500-301-RD, U1111-1132-3434
Study First Received: April 20, 2012
Last Updated: February 5, 2014
Health Authority: Belarus: Ministry of Health
Kazakhstan: Ministry of Public Health
Russia: Ministry of Health of the Russian Federation

Keywords provided by Takeda:
Post-Stroke Cognitive Impairment (PSCI)
Stroke
Actovegin
Cognition disorders

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cognition Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Actovegin
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Radiation-Protective Agents

ClinicalTrials.gov processed this record on April 15, 2014