Tongxinluo Capsule in Ischemic Stroke Patients（TISS)

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Drug: Tongxinluo capsule; Drug: placebo capsule

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.

• Study Type: Interventional
• Enrollment (Actual): 2007
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Tiantan Hospital,Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tongxinluo capsule; Tongxinluo capsule,4 granules,t.i.d. po,for 90 days	Drug: Tongxinluo capsule; for 90 days; Other Names: Yiling Pharmaceutical，Z19980015
Placebo Comparator: placebo capsule; placebo capsule,4 granules,t.i.d. po,for 90 days	Drug: placebo capsule; for 90 days; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with National Institutes of Health Stroke Score (NIHSS) reaching 0-1 or reduction 4 points .	Baseline, 7days, discharge date, 90 days
Proportion of patients with Bathel Index（BI）score more than 85.	Baseline, 7days, discharge date, 90 days
Continuous changes of Modified Rankin Scale score.	Baseline, 7days, discharge date, 90 days
Incidence of ischemic cerebrovascular disease (ischemic stroke/TIA/ new ischemic lesion in MRI Images.	90 days
Incidence of new combination clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death).	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MR indicated symptomatic or non-symptomatic cerebral infarction emerging	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.	90 days

Collaborators and Investigators

• Sponsor: yongjun wang
• Investigators: Study Director: Yongjun Wang, professor, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: August 7, 2013
• First Posted (Estimate): August 9, 2013

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 3, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Ischemic Stroke; Tongxinluo capsule
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: yl-yxb09-lcsyfa-201301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No