NCT01582854

Brief Summary

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 received IV infusions whilst in hospital, and tablets once discharged. Subjects were followed up for a further six months after their treatment had been stopped to explore if the cognitive symptoms of the subjects treated with Actovegin showed sustained improvement. The trial also explored the possible prevention of dementia with Actovegin in patients who had suffered a recent ischaemic stroke, as well as the effect of Actovegin on other stroke outcomes. Safety information on Actovegin was collected.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
503

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2012

Geographic Reach
3 countries

14 active sites

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

First Submitted

Initial submission to the registry

April 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 22, 2016

Completed
Last Updated

February 22, 2016

Status Verified

January 1, 2016

Enrollment Period

2.4 years

First QC Date

April 20, 2012

Results QC Date

January 23, 2016

Last Update Submit

January 23, 2016

Conditions

Post-Stroke Cognitive Impairment (PSCI)

Keywords

Post-Stroke Cognitive Impairment (PSCI)StrokeActoveginCognition disorders

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+) at Month 6

    The ADAS-cog measures cognitive performance by combining the ratings of 11 items. The cognitive domains mainly addressed by ADAS-cog are: memory (short term), language, ability to orientate (reflects memory), construction/planning of simple designs and performance. The extended version of the ADAS-cog (ADAS-cog+) includes 3 additional items: a 2-number cancellation task to test for attention, a delayed recall task to test for memory consolidation and a maze test for executive performance. Each item is scored and then the item scores are totaled. Total scores range from 0 (best) to 90 (worst). Higher scores indicate greater cognitive impairment. A negative change from Baseline indicates improvement. Analysis of Covariance (ANCOVA) model was used for analyses that included treatment, pooled centre, and their interaction as factors and Baseline ADAS-cog+ score as a covariate.

    Baseline and Month 6

Secondary Outcomes (11)

  • Change From Baseline in ADAS-cog+ at Month 3 and Month 12

    Baseline and Months 3 and 12

  • Change From Baseline in Montreal Cognitive Assessment Scale (MoCA) at End of Infusion Period, Months 3, 6 and 12

    Baseline, End of Infusion and Months 3, 6 and 12

  • Percentage of ADAS-cog+ Responders at Time Points 3, 6 and 12 Months

    Baseline and Months 3, 6 and 12

  • Percentage of Participants With a Diagnosis of Dementia

    Month 6

  • Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) at End of Infusion Period, Months 3, 6 and 12

    Baseline and End of Infusion and Months 3, 6 and 12

  • +6 more secondary outcomes

Study Arms (2)

Actovegin

ACTIVE COMPARATOR

Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.

Drug: Actovegin

Placebo

PLACEBO COMPARATOR

Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.

Drug: Placebo

Interventions

ActoveginDRUG

Actovegin solution for infusion and Actovegin tablets

Actovegin
PlaceboDRUG

Actovegin placebo-matching solution for infusion and Actovegin placebo-matching tablets

Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant has suffered a recent supra-tentorial ischaemic stroke supported by computed tomography (CT) scan or magnetic resonance imaging (MRI) findings (in accordance with local practice).
  • Participant is male or female, aged 60 years or above.
  • Participant has a score on the National Institute of Health Stroke Scale (NIHSS) between 3 and 18 (inclusive).
  • Participant 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).

You may not qualify if:

  • Participant has a medical history of dementia.
  • Participant has a known medical history of major depression or psychotic disorder.
  • Participant is indicated for treatment with thrombolytics or carotid surgery as the current standard of care.
  • Randomisation Criteria:
  • Ability to perform Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+).
  • Clinically there is suspicion of progressive stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Nycomed Investigational Site

Grodno, Belarus

Location

Nycomed Investigational Site

Minsk, Belarus

Location

Nycomed Investigational Site

Vitebsk, Belarus

Location

Nycomed Investigational Site

Almaty, Kazakhstan

Location

Nycomed Investigational Site

Barnaul, Russia

Location

Nycomed Investigational Site

Irkutsk, Russia

Location

Nycomed Investigational Site

Kazan', Russia

Location

Nycomed Investigational Site

Krasnoyarsk, Russia

Location

Nycomed Investigational Site

Moscow, Russia

Location

Nycomed Investigational Site

Novosibirsk, Russia

Location

Nycomed Investigational Site

Saint Petersburg, Russia

Location

Nycomed Investigational Site

Samara, Russia

Location

Nycomed Investigational Site

Tomsk, Russia

Location

Nycomed Investigational Site

Yekaterinburg, Russia

Location

Related Publications (1)

  • Guekht A, Skoog I, Edmundson S, Zakharov V, Korczyn AD. ARTEMIDA Trial (A Randomized Trial of Efficacy, 12 Months International Double-Blind Actovegin): A Randomized Controlled Trial to Assess the Efficacy of Actovegin in Poststroke Cognitive Impairment. Stroke. 2017 May;48(5):1262-1270. doi: 10.1161/STROKEAHA.116.014321.

    PMID: 28432265DERIVED

MeSH Terms

Conditions

StrokeCognition Disorders

Interventions

Actovegin

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Medical Director, Clinical Science
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2012

First Posted

April 23, 2012

Study Start

June 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

February 22, 2016

Results First Posted

February 22, 2016

Record last verified: 2016-01

Locations

BE(3)KA(1)RU(10)