Ischemic StrokePhase 4NCT01919671
Tongxinluo Capsule in Ischemic Stroke Patients（TISS)
A Phase 4 study testing Tongxinluo capsule in people with Ischemic Stroke, run by yongjun wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Tongxinluo capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,007 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Tongxinluo capsule, placebo capsule
- Keywords
- Ischemic Stroke, Tongxinluo capsule
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongxinluo capsuleDrug
Also called Yiling Pharmaceutical，Z19980015
for 90 days
placebo capsuleDrug
Also called placebo
for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Tongxinluo capsule | Experimental | Tongxinluo capsule,4 granules,t.i.d. po,for 90 days Receives: Drug: Tongxinluo capsule |
| placebo capsule | Placebo comparator | placebo capsule,4 granules,t.i.d. po,for 90 days Receives: Drug: placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 at 90 days.
Measured: 90 days
Secondary outcomes (5)
Proportion of patients with National Institutes of Health Stroke Score (NIHSS) reaching 0-1 or reduction 4 points .
Measured: Baseline, 7days, discharge date, 90 days
Proportion of patients with Bathel Index（BI）score more than 85.
Measured: Baseline, 7days, discharge date, 90 days
Continuous changes of Modified Rankin Scale score.
Measured: Baseline, 7days, discharge date, 90 days
Incidence of ischemic cerebrovascular disease (ischemic stroke/TIA/ new ischemic lesion in MRI Images.
Measured: 90 days
Incidence of new combination clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death).
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startMar 2014
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- yongjun wang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, yongjun wang, Ministry of Science and Technology of the People´s Republic of China
- Investigators
- Yongjun Wang, professor, Study director, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919671
- Sponsor's protocol ID
- yl-yxb09-lcsyfa-201301
- Status last verified
- Jan 2017
- First submitted
- 7 Aug 2013
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39325453
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Evaluation, Multicenter Clinical Study of Tongxinluo Capsule in Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT01919671
- Acronym / sponsor ID
- yl-yxb09-lcsyfa-201301
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, Tongxinluo capsule
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,007 participants (actual)
- Lead sponsor
- yongjun wangOther government
- Study start
- Mar 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tongxinluo capsule | Experimental | Drug: Tongxinluo capsuleTongxinluo capsule,4 granules,t.i.d. po,for 90 days |
| placebo capsule | Placebo comparator | Drug: placebo capsuleplacebo capsule,4 granules,t.i.d. po,for 90 days |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tongxinluo capsuleAlso: Yiling Pharmaceutical，Z19980015for 90 days | Drug | Tongxinluo capsule |
| placebo capsuleAlso: placebofor 90 days | Drug | placebo capsule |
Primary outcome
Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 at 90 days.
Time frame: 90 days
5 secondary outcomes
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
Proportion of patients with Bathel Index（BI）score more than 85.
Time frame: Baseline, 7days, discharge date, 90 days
Continuous changes of Modified Rankin Scale score.
Time frame: Baseline, 7days, discharge date, 90 days
Incidence of ischemic cerebrovascular disease (ischemic stroke/TIA/ new ischemic lesion in MRI Images.
Time frame: 90 days
Incidence of new combination clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death).
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Derived from this study: PubMed 39325453Dong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongjun Wang, professor study director
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tongxinluo capsule in people with Ischemic Stroke, run by yongjun wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 at 90 days. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01919671, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.