Observational Study of Efficiency of Cytoflavin, in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPOLYSAN Scientific & Technological Pharmaceutical Company

About this trial

Stroke remains one of the main socially significant problems in the healthcare in the third millennium. The lethality in persons with history of stroke by the end of the 1st year of disease is high. A trend to increased frequency of stroke in the young age is observed during the last decade; third of patients is working-age individuals, out of whom only 15-20% returns to labor, and others remain disabled persons requiring constant medical and social support

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent form

Age from 18 years and older

Diagnosis: Acute cerebrovascular accident of ischemic type (ischemic stroke) developed within 36 hours before enrollment in the study

Motor neurologic deficit measurable using the NIHSS Scale (score for item 5 and/or 6 at the time of starting the therapy ≥ 1))

Disqualifiers

NIHSS 1a (coma) score 3 at the time of enrollment

Initial severe disablement (corresponding to mRS > 2) requiring external assistance in everyday life before development of stroke

History of Parkinson's disease, dementia, multiple sclerosis, and other significant diseases accompanied by neurologic deficit

Severe comorbidity with expected lifespan of not more than 6 months

Trial population

Patients aged above 18 years with diagnosis of ACVA of ischemic type who did not receive and are not scheduled for reperfusion therapy (thrombolysis, thrombus extraction).

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Cytoflavin

    Drug

    Cytoflavin solution for infusions. 20-40 ml/day (10 ml with the interval of 8-12 hours for 10 days; the single dose is increased up to 20 ml in case of the severe form of the disease) by intravenous drop infusion in dilution per 100-200 ml of 0.9% sodium chloride solution for 10 days; rate of administration: 3-4 ml/min

Treatment groups

562 Participants
are divided into 2 treatment groups
Group A: The test group1 intervention
Group B: The control group0 interventions

Trial outcomes

Primary outcomes

1

Percentage of patients with favorable functional outcome (score 0-2) according to Modified Rankin Scale (mRS) on Day of Discharge (assessment at Visit 4 or Visit 5, on Day of Discharge) and on Day 90;

Modified Rankin Scale (mRS)

Time frame
Base, day 14, day 21, day 90

Secondary outcomes

1

Total score according to Modified Rankin Scale (mRS) on Day of Discharge and Day 90 in the test and control group;

Modified Rankin Scale (mRS)

Time frame
Day 14, day 21, day 90
2

Total score according to Rivermead Scale on Day 7, Day 14, Day 21, and Day 90 in the test and control group

Rivermead Scale

Time frame
Day 7, day 14, day 21, day 90
3

Change of the total score according to National Institute of Health Stroke Scale (NIHSS) on Day 3, Day 7, Day 14, and Day 21 as compared to the baseline level (Day 1);

National Institute of Health Stroke Scale (NIHSS)

Time frame
Day 7, day 14, day 21, day 90
4

Change of the total score according to Stroke-Specific Quality of Life Scale (SS-QOL) on Day 90 as compared to Day of Discharge;

Stroke-Specific Quality of Life Scale (SS-QOL)

Time frame
Day 14, day 21, day 90

Other outcomes

Sponsors and contacts

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