## Protocol Section
### Identification Module
**NCT ID:** NCT06437626

**Acronym:** MIR

**Brief Title:** MEXIDOL® Sequential Therapy of Patients With Acute Cerebral Failure

**Official Title:** Prospective International Multicenter Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety Evaluation of the Mexidol® Sequential Therapy of Patients in the Acute and Early Recovery Periods of Ischemic Stroke

#### Organization Study ID Info
**ID:** MexidolMIR2023
#### Organization
**Class:** INDUSTRY
**Full Name:** Pharmasoft
#### Secondary ID Infos
**Domain:** Ministry of Health, Russian Federation
**ID:** PHS-APIS-004-MEX-SOL-TAB
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2023-08-18

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-08-18

**Type:** ACTUAL

#### Start Date
**Date:** 2019-11-18

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pharmasoft

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Cerebral stroke is one of the most pressing clinical and social problems of modern medicine. According to WHO estimates, acute cerebral failure rank second among all causes of death. Optimizing the treatment of such conditions remains an urgent problem in neurology and rehabilitation.

**Detailed Description:** Hypothesis: The addition of neurocytoprotectors to standard therapy in the acute and early recovery periods of Ischemic Stroke helps improve the results of further rehabilitation and reduce the severity of neurological deficit. The multimodal mechanism of action allows Mexidol® to realize a whole range of clinical effects, primarily such as anti-ischemic, vegetotropic, anti-amnestic, nootropic, anxiolytic, anticonvulsant, etc.).

### Conditions Module

**Conditions:**

- Ischemic Stroke, Acute

**Keywords:**

- Ischemic Stroke

- Acute Stroke

- Cerebral stroke

- Acute Cerebrovascular Accident

- ACVA

- Acute cerebral failure

- Neuroprotection

- Mexidol

- Ethylmethylhydroxypyridine Succinate

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 304

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Mexidol IV 500 mg 2 times a day for 10 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days

**Intervention Names:**

- Drug: Mexidol

**Label:** Main (Mexidol and standard therapy)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Placebo and standard therapy according to a scheme similar to the main group

**Intervention Names:**

- Other: Placebo

**Label:** Control (Placebo and standard therapy)

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Main (Mexidol and standard therapy)

**Description:** Neurocytoprotector

**Name:** Mexidol

**Other Names:**

- Ethylmethylhydroxypyridine Succinate

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Control (Placebo and standard therapy)

**Description:** Placebo therapy

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The Modified Rankin Scale (mRS) \[6 point scale: min value 0, max value 5, higher scores mean a worse outcome\]

**Measure:** Measures the degree of disability or dependence in the daily activities

**Time Frame:** 71 days

#### Secondary Outcomes

**Description:** The National Institutes of Health Stroke Scale (NIHSS) \[43 point scale: min value 0, max value 42, higher scores mean a worse outcome\]

**Measure:** Quantifying stroke severity

**Time Frame:** 71 days

**Description:** The Rivermead index \[16 point scale: min value 0, max value 15, higher scores mean a better outcome\]

**Measure:** Dynamics of level of mobility

**Time Frame:** 71 days

**Description:** The Montreal Cognitive Assessment (MoCA test) \[31 point scale: min value 0, max value 30, higher scores mean a better outcome\]

**Measure:** Dynamics of cognitive status

**Time Frame:** 71 days

**Description:** The Hospital Anxiety and Depression Scale (HADS) \[43 point scale: min value 0, max value 42, higher scores mean a worse outcome\]

**Measure:** Reduction in anxiety

**Time Frame:** 71 days

**Description:** Adverse events related to Mexidol

**Measure:** Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

**Time Frame:** 71 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Acute Ischemic Stroke confirmed by neuroimaging methods (CT, MRI)
* Modified Rankin Scale, mRS ≥ 3
* National Institutes of Health Stroke Scale: 9 ≤ NIHSS ≤ 15

Exclusion Criteria:

* Repeated or hemorrhagic stroke;
* Traumatic brain injury with severe neurological symptoms and cognitive impairment;
* Patients who have undergone thrombolytic therapy or thrombectomy;
* History of clinically significant allergic reactions, hypersensitivity and/or intolerance to any component of the study drug or placebo;
* Parkinson's disease, parkinsonism, multiple sclerosis, epilepsy, degenerative diseases of the central nervous system (CNS), history of dementia of the Alzheimer's type;
* BMI (Body Mass Index) \> 35
* Systemic autoimmune diseases or vascular collagenoses requiring previous or current treatment with systemic corticosteroid drugs, cytostatics;
* Malignant neoplasms within the last 5 years;
* Need to use drugs prohibited in this study;
* Having a positive result of a rapid test for IgM antibodies to the SARS-CoV-2 virus;
* Need for surgical intervention;
* History of alcohol or drug addiction;
* Positive result of at least one of the following tests: blood test for HIV, syphilis, hepatitis B and C;
* Pregnancy or lactation period;
* Participation of the patient in any clinical trial less than 3 months before the start of the present one.

**Maximum Age:** 75 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Almaty

**Country:** Kazakhstan

**Facility:** Almaty City Hospital № 7

**Zip:** 050006

**Location 2:**

**City:** Kazan

**Country:** Russian Federation

**Facility:** Tatarstan Republican Clinical Hospital

**Zip:** 410064

**Location 3:**

**City:** Kazan

**Country:** Russian Federation

**Facility:** Interregional Clinical Diagnostic Center

**Zip:** 420101

**Location 4:**

**City:** Kazan

**Country:** Russian Federation

**Facility:** Kazan City Hospital № 7

**Zip:** 420103

**Location 5:**

**City:** Kemerovo

**Country:** Russian Federation

**Facility:** Kemerovo City Clinical Hospital № 11

**Zip:** 650014

**Location 6:**

**City:** Krasnodar

**Country:** Russian Federation

**Facility:** Research Institute - Regional Clinical Hospital № 1

**Zip:** 350086

**Location 7:**

**City:** Moscow

**Country:** Russian Federation

**Facility:** Federal Center for Brain and Neurotechnology

**Zip:** 117997

**Location 8:**

**City:** Moscow

**Country:** Russian Federation

**Facility:** Russian National Research Medical University n.a. N. I. Pirogov

**Zip:** 117997

**Location 9:**

**City:** Rostov-on-Don

**Country:** Russian Federation

**Facility:** Rostov State Medical University

**Zip:** 344022

**Location 10:**

**City:** Saint Petersburg

**Country:** Russian Federation

**Facility:** Alexandrovskaya Hospital

**Zip:** 193312

**Location 11:**

**City:** Saint Petersburg

**Country:** Russian Federation

**Facility:** St. Petersburg Clinical Hospital № 26

**Zip:** 196247

**Location 12:**

**City:** Saint Petersburg

**Country:** Russian Federation

**Facility:** National Medical Research Center n.a. V. A. Almazov

**Zip:** 197341

**Location 13:**

**City:** Saint Petersburg

**Country:** Russian Federation

**Facility:** City Hospital № 40 of Kurortny District

**Zip:** 197706

**Location 14:**

**City:** Samara

**Country:** Russian Federation

**Facility:** Samara Regional Clinical Hospital n.a. V. D. Seredavin

**Zip:** 443095

**Location 15:**

**City:** Ulyanovsk

**Country:** Russian Federation

**Facility:** Central Clinical Medical and Sanitary Unit n.a. V. A. Egorov

**Zip:** 432026

**Location 16:**

**City:** Voronezh

**Country:** Russian Federation

**Facility:** Voronezh Regional Clinical Hospital № 1

**Zip:** 394066

**Location 17:**

**City:** Vsevolozhsk

**Country:** Russian Federation

**Facility:** Vsevolozhsk Clinical Interdistrict Hospital

**Zip:** 188643

**Location 18:**

**City:** Yaroslavl

**Country:** Russian Federation

**Facility:** Yaroslavl Clinical Hospital № 2

**Zip:** 150030

**Location 19:**

**City:** Tashkent

**Country:** Uzbekistan

**Facility:** The first clinic of the Tashkent Medical Academy

**Zip:** 100109

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M22306

- Name: Stroke

- Relevance: HIGH

- As Found: Stroke

- ID: M2400

- Name: Ischemic Stroke

- Relevance: HIGH

- As Found: Ischemic Stroke

- ID: M10543

- Name: Ischemia

- Relevance: HIGH

- As Found: Ischemic

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020521

- Term: Stroke

- ID: D000083242

- Term: Ischemic Stroke

- ID: D000007511

- Term: Ischemia

### Intervention Browse Module - Ancestors

- ID: D000000975

- Term: Antioxidants

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000010975

- Term: Platelet Aggregation Inhibitors

- ID: D000011619

- Term: Psychotropic Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: PlAggInh

- Name: Platelet Aggregation Inhibitors

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M249938

- Name: Emoxypine succinate

- Relevance: HIGH

- As Found: Gene analysis

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M13865

- Name: Platelet Aggregation Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000070020

- Term: Emoxypine succinate

### Misc Info Module

- Version Holder: 2024-05-31
