Tongxinluo Capsule in Ischemic Stroke Patients（TISS)

NCT01919671 | Completed Phase 4 DMC

• 1 other identifier: yl-yxb09-lcsyfa-201301
• Study Type: interventional
• Target: 2,007
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke; Tongxinluo capsule

Outcome Measures

Primary Outcomes (1)

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

  90 days

Secondary Outcomes (5)

• 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 Outcomes (1)

• MR indicated symptomatic or non-symptomatic cerebral infarction emerging

  90 days

Study Arms (2)

Tongxinluo capsule

EXPERIMENTAL

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

Drug: Tongxinluo capsule

placebo capsule

PLACEBO COMPARATOR

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

Drug: placebo capsule

Interventions

Tongxinluo capsule DRUG

for 90 days

Also known as: Yiling Pharmaceutical，Z19980015

Tongxinluo capsule

placebo capsule DRUG

for 90 days

Also known as: placebo

placebo capsule

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• yongjun wang: lead

Study Sites (1)

Beijing TianTan Hospital,Capital Medical University

Beijing, China

Location

Related Publications (1)

• Dong Y, Jiang K, Li Z, Zhou Y, Ju B, Min L, He Q, Fan P, Hu W, Qu H, Wu H, Pan C, Cao Y, Lou X, Zhang G, Zhang J, Hu F, Dong Q; TISS Trial Investigators. Tongxinluo and Functional Outcomes Among Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2433463. doi: 10.1001/jamanetworkopen.2024.33463.

  PMID: 39325453 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

tongxinluo

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yongjun Wang, professor

  Beijing Tiantan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice president of Beijing Tiantan Hospital

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 9, 2013
• Study Start: March 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 4, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)