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Tongxinluo Capsule in Ischemic Stroke Patients（TISS)

Primary Purpose

Ischemic Stroke

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Tongxinluo capsule

placebo capsule

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic Stroke, Tongxinluo capsule

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ischemic stoke within 72 after onset, confirmed by MRI or CT.
Age 35-75 years, inclusive.
Patients with the first attack or patients with stroke history(modified Rankin Scale score 0-1).
Clear signs of localization of nervous system, NIHSS score 4 to 22.
Patient or proxy has signed informed consent.

Exclusion Criteria:

Hemorrhage diseases according to head CT or MRI, such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, haemorrhage after cerebral infarction.
Transient Ischemic Attack (TIA).
Severe disturbance of consciousness: 1a of NIHSS score>1 point; Difficulty in swallowing, unable to take oral capsules; any of 5a, 5b, 6a, 6b of NIHSS score>2 point.
Convinced of stroke caused by brain tumor, brain trauma, hemopathy, etc.
Hemorrhagic tendency patients.
Patients with endovascular treatment after the onset of stroke.
Patients with dementia, severe Parkinson's disease, mental disorders, limb dysfunction caused by other diseases or other conditions that may affect the therapeutic efficacy.
Uncontrolled hypertension (≥200 mmHg systolic or ≥110 mmHg diastolic) or hypotension (≤90 mmHg systolic or ≤60mmHg diastolic); severe hyperglycemia(blood glucose ≥400 mg/dl) or hypoglycemia( blood glucose≤50 mg/dl).
Severe hepatic insufficiency defined as transaminase values > 2x upper limit of normal; severe renal insufficiency defined as values serum creatinine> 1.5x upper limit of normal; cardiac dysfunction or other serious systemic disease with life expectancy ≤3 months.
Patients with concurrent malignancy or ongoing anti-tumor therapy.
Patients with history of being allergic to the trial medicine.
Pregnancy, breastfeeding or potential pregnancy.
Within three months or currently participating in another investigational study.
Any other condition that in the opinion of the investigator should preclude study participation.

Sites / Locations

Beijing TianTan Hospital,Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tongxinluo capsule

placebo capsule

Arm Description

Tongxinluo capsule,4 granules,t.i.d. po,for 90 days

placebo capsule,4 granules,t.i.d. po,for 90 days

Outcomes

Primary Outcome Measures

Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 at 90 days.

Secondary Outcome Measures

Proportion of patients with National Institutes of Health Stroke Score (NIHSS) reaching 0-1 or reduction 4 points .

Proportion of patients with Bathel Index（BI）score more than 85.

Continuous changes of Modified Rankin Scale score.

Incidence of ischemic cerebrovascular disease (ischemic stroke/TIA/ new ischemic lesion in MRI Images.

Incidence of new combination clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death).

Full Information

NCT ID

NCT01919671

First Posted

August 7, 2013

Last Updated

January 3, 2017

Sponsor

yongjun wang

1. Study Identification

Unique Protocol Identification Number

NCT01919671

Brief Title

Tongxinluo Capsule in Ischemic Stroke Patients（TISS)

Official Title

A Randomized, Double-blind, Placebo Controlled Evaluation, Multicenter Clinical Study of Tongxinluo Capsule in Ischemic Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

yongjun wang

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to assess the effects in improving life self-care ability of stroke patients after taking Tongxinluo Capsule(within 72 hours after onset) versus Placebos for 90 days.

Detailed Description

The study is a randomized, double-blind, placebo controlled, multi-center trial. We aim to enroll a total of 1968 individuals(984 cases in each group) with acute ischemic stroke less than 72 hours after onset. Participants will be randomized into Tongxinluo capsule treatment group with the capsule administration of 4 granules tid. for 90 days, while the patients in the control group receive placebo capsule. NIH Stroke Score of the subjects is 4-22 at randomization. Evaluations of efficacy and safety will be taken at baseline, 7 days, discharge date and 90 days. Neuroimaging [magnetic resonance imaging (MRI) scans] will be obtained at baseline and 90 days after therapy. The primary efficacy endpoint is the proportion of Modified Rankin Scale (mRS) ≤1 at 90 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

Keywords

Ischemic Stroke, Tongxinluo capsule

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2007 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tongxinluo capsule

Arm Type

Experimental

Arm Description

Tongxinluo capsule,4 granules,t.i.d. po,for 90 days

Arm Title

placebo capsule

Arm Type

Placebo Comparator

Arm Description

placebo capsule,4 granules,t.i.d. po,for 90 days

Intervention Type

Drug

Intervention Name(s)

Tongxinluo capsule

Other Intervention Name(s)

Yiling Pharmaceutical，Z19980015

Intervention Description

for 90 days

Intervention Type

Drug

Intervention Name(s)

placebo capsule

Other Intervention Name(s)

placebo

Intervention Description

for 90 days

Primary Outcome Measure Information:

Title

Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 at 90 days.

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Proportion of patients with National Institutes of Health Stroke Score (NIHSS) reaching 0-1 or reduction 4 points .

Time Frame

Baseline, 7days, discharge date, 90 days

Title

Proportion of patients with Bathel Index（BI）score more than 85.

Time Frame

Baseline, 7days, discharge date, 90 days

Title

Continuous changes of Modified Rankin Scale score.

Time Frame

Baseline, 7days, discharge date, 90 days

Title

Incidence of ischemic cerebrovascular disease (ischemic stroke/TIA/ new ischemic lesion in MRI Images.

Time Frame

90 days

Title

Incidence of new combination clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death).

Time Frame

90 days

Other Pre-specified Outcome Measures:

Title

MR indicated symptomatic or non-symptomatic cerebral infarction emerging

Description

Compared with baseline MRI, re-examination of MRI shows new infarct diagnosed by DWI or FLARI (including new infarct and enlargement of infarct size) in areas other than the original infarct in DWI and FLAIR-sequence.

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ischemic stoke within 72 after onset, confirmed by MRI or CT. Age 35-75 years, inclusive. Patients with the first attack or patients with stroke history(modified Rankin Scale score 0-1). Clear signs of localization of nervous system, NIHSS score 4 to 22. Patient or proxy has signed informed consent. Exclusion Criteria: Hemorrhage diseases according to head CT or MRI, such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, haemorrhage after cerebral infarction. Transient Ischemic Attack (TIA). Severe disturbance of consciousness: 1a of NIHSS score>1 point; Difficulty in swallowing, unable to take oral capsules; any of 5a, 5b, 6a, 6b of NIHSS score>2 point. Convinced of stroke caused by brain tumor, brain trauma, hemopathy, etc. Hemorrhagic tendency patients. Patients with endovascular treatment after the onset of stroke. Patients with dementia, severe Parkinson's disease, mental disorders, limb dysfunction caused by other diseases or other conditions that may affect the therapeutic efficacy. Uncontrolled hypertension (≥200 mmHg systolic or ≥110 mmHg diastolic) or hypotension (≤90 mmHg systolic or ≤60mmHg diastolic); severe hyperglycemia(blood glucose ≥400 mg/dl) or hypoglycemia( blood glucose≤50 mg/dl). Severe hepatic insufficiency defined as transaminase values > 2x upper limit of normal; severe renal insufficiency defined as values serum creatinine> 1.5x upper limit of normal; cardiac dysfunction or other serious systemic disease with life expectancy ≤3 months. Patients with concurrent malignancy or ongoing anti-tumor therapy. Patients with history of being allergic to the trial medicine. Pregnancy, breastfeeding or potential pregnancy. Within three months or currently participating in another investigational study. Any other condition that in the opinion of the investigator should preclude study participation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yongjun Wang, professor

Organizational Affiliation

Beijing Tiantan Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Beijing TianTan Hospital,Capital Medical University

City

Beijing

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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Tongxinluo Capsule in Ischemic Stroke Patients（TISS)

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