An Observational Registry Study of LUOTAI in Patients With Acute Ischemic Stroke in Vietnam

NCT03679364 | Completed DMC

• 1 other identifier: KPC.VS.01
• Study Type: observational
• Target: 364
• Locations: 1 country
• Sites: 3

Brief Summary

Ischemic stroke occurs when an artery to the brain is blocked. If the artery remains blocked for more than a few minutes, the brain cells may die. This is why immediate medical treatment is critical. Luotai® is the brand name of Panax notoginseng finished product. 2 kinds of formulation are available, the lyophilized powder for Injection and gelatin based soft capsule. They are being used for decreasing incidence of cerebral infarction or ischemic stroke. This study will be conducted as an observational study, regarding the safety, effectiveness of Luotai treatment in acute ischemic stroke patients. This study will be carried out in approximately 360 patients with acute stroke in 6 hospitals in Vietnam - Bạch Mai Hospital, 108 Military Hospital, 103 Military Hospital, Trung Vuong Hospital, Phu Tho General Hospital, 115 Hospital. STUDY PROCEDURES: Participants will be enrolled in an unbiased manner (by consecutive sampling) and consecutive sampling method. The investigators will record participants' information required by the Case Report Form. The study which last for about 3 months, and in each of the visit, the information will be collected includes informed consent, demographic data, ischemic stroke assessment, concomitant medication, adverse reactions. A travel transportation allowance of VND 300,000 will be given for each visit. Participants will receive Luotai and other medications according to the local hospital practice in accordance with the terms of the local marketing authorization in Vietnam. The recommended dosage of Luotai is: Luotai™ injectable lyophilized powder for consecutive 14 days, Luotai soft capsules for 65 days. The participation of the study is fully voluntarily. Patients decide not to participate in the study will not be disadvantaged in any way. All collected information from participants is protected as confidential. The results of the study may be published in medical literature, but participants will not be identified. This study does not include any procedure/test that there were not indicated according to local clinical practice. There is no specific associated risks or discomforts in this study related to the participation. The results of this research may guide in further understanding the Ischemic Stroke.

Conditions

Infarction, Anterior Cerebral Artery; Infarction, Middle Cerebral Artery; Ischemic Attack, Transient

Keywords

Panax notoginseng; acute ischemic stroke; Vietnam; observational registry study; lyophilized; injectable

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Endpoint: Modified Ranking Scale

  Modified Rankin Scale (mRS) is an overall functional outcome measure, measuring stroke defect. Answer the test questions for 5-10 minutes. The score range is 7 points with a score of 0 for the absence of sequelae and the worst possible score is 6. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. Primary Efficacy Endpoint defined as "Categorical shift in mRS score at 3 months (ordinal logistic regression analysis of the mRS on Day 90)".

  3 months

Secondary Outcomes (4)

• NIHSS

  on Day 0, 7, 90

• Cognitive status (MoCA)

  on Day 90

• mRC Proportion

  on Day 90

• ARAT Score

  on Day 90

Study Arms (2)

LUOTAI group

LUOTAI group treated with LUOTAI with dosage, dosing schedule and duration follows local clinical practice in accordance with the terms of the local marketing authorization: 400mg of LUOTAI injectable lyophilized powder diluted in 250ml of 5% Glucose Solution or 0.9% Normal Saline for included diabetic patients, via slow intravenous infusion, once daily for consecutive 14 days, and followed by 200mg of LUOTAI soft capsules, three times a day for 65 days.

Control group

Control group comprises of patients who are not treated with LUOTAI, and follows local clinical practice for ischemic stroke.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients receive acute stroke care according to local treatment standard, not amended or influenced by the study. LUOTAI group comprises of patients who are treated with LUOTAI (and other concomitant medications) with dosage, dosing schedule and duration follows local clinical practice in accordance with the terms of the local marketing authorization. Control group comprises of patients who are not treated with LUOTAI.

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 or above
• Clinical diagnosis of acute ischemic stroke
• Patient's independence prior to stroke onset (pre-morbid mRC of 0-1)
• Reasonable expectation of successful follow-up (up to D90)

You may not qualify if:

• \. Treatment with another investigational drug or other investigational interventions within 1 month prior to this study.

Sponsors & Collaborators

• KPC Pharmaceuticals, Inc: lead

Study Sites (3)

Bach Mai Hospital

Hà Nội, Hà Nội, Vietnam

Location

Phu Tho General Hospital

Tỉnh Phú, Phu Tho, Vietnam

Location

103 Military Hospital

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Infarction, Anterior Cerebral Artery; Infarction, Middle Cerebral Artery; Ischemic Attack, Transient; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Huy Thắng Nguyễn, MD.

  115 Hospital

  PRINCIPAL INVESTIGATOR

• Đình Đài Phạm, MD.

  103 Military Hospital

  PRINCIPAL INVESTIGATOR

• Huy Ngọc Nguyễn, MD. PhD.

  Phu Tho General Hospital

  PRINCIPAL INVESTIGATOR

• Văn Thính Lê, MD.

  Bach Mai Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 20, 2018
• Study Start: July 2, 2019
• Primary Completion: August 15, 2020
• Study Completion: August 20, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

VN (3)