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Ischemic StrokePhase 4NCT02334969

Curative Efficacy of Secondary Prevention for Patients With Ischemic Stroke Through Syndrome Differentiation of TCM

A Phase 4 study testing Naoxintong Capsule in people with Ischemic Stroke, run by Xiaofei Yu at 24 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the efficacy and safety of Naoxintong Capsule in the secondary prevention of ischemic stroke by the multi-center, randomized,double-blind，placebo-controlled trial design project. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Ischemic Stroke
What is being tested?
Naoxintong Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,200 participants
Where
24 sitesChina
Study dates
Apr 2016to 30 Aug 2018
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 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult volunteers aged ≤ 90 years old, ≥18 years old；
  • Conforming to the diagnostic criteria of cerebral infarction under the 2010 version of Chinese Guidelines for Treatment of Acute Ischemic Stroke；
  • Conforming to diagnostic criteria of the stasis type of TCM on the ischemic stroke；
  • The onset of acute cerebral infarction ≥ 10 days；
  • Consciousness awake；
  • Volunteers agree to accept the program and sign informed consent.

Who cannot join

  • Excluding the patients of the yin deficiency type of ischemic stroke.The diagnostic criteria of Yin deficiency type of ischemic stroke is that sudden onset of disease；being signs or symptoms of of neurological deficit；CT or MRI examination showing intracranial ischemic lesions；Scarlet tongue；
  • The volunteers with severe heart diseases, cardiac insufficiency, hepatosis, renal insufficiency, respiratory failure, malignant tumour, alimentary tract hemorrhage, etc. who may fail to complete the two-year follow-up；
  • Psychiatric patients；
  • Pregnants and lactating women；
  • Volunteers in other clinical trials；
  • Volunteers who are not suitable for this clinical trial according to the researchers for other reasons.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

China24 sites

  • Shanghai seventh People's Hospital

    Shanghai, Shanghai Municipality, 200000

  • Shanghai Ninth People's Hospital affliated to Shanghai Jiao Tong University Shool of Medcine

    Shanghai, Shanghai Municipality, 200011

  • North Branch of Ruijin Hospital affliated to Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200020

  • Shanghai Putuo Central Hospital

    Shanghai, Shanghai Municipality, 200021

  • Shuguang Hospital affliated to Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 200021

  • Longhua Hospital affliated to Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 200032

  • Zhongshan Hospital affliated to Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Huashan Hospital affliated to Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai fifth People's Hospital affliated to Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Tongren Hospital affliated to Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200050

  • Tongji Hospital

    Shanghai, Shanghai Municipality, 200065

  • Shanghai Chinese Medicine Hospital

    Shanghai, Shanghai Municipality, 200071

  • Shanghai tenth People's Hospital

    Shanghai, Shanghai Municipality, 200072

  • Shanghai Hospital of Integrative Medicine

    Shanghai, Shanghai Municipality, 200082

  • Xinhua Hospital affliated to Shanghai Jiao Tong University Shool of Medcine

    Shanghai, Shanghai Municipality, 200092

  • Dongfang Hospital affliated to Tongji University

    Shanghai, Shanghai Municipality, 200120

  • Pudong Gong Li Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200135

  • Shanghai sixth People's Hospital affliated to Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200233

  • Changning Tongren Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200336

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

  • Pudong Hospital of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 201200

  • East Branch of Shanghai sixth People's Hospital

    Shanghai, Shanghai Municipality, 201306

  • Qingpu Branch of Zhongshan Hospital affliated to Fudan University

    Shanghai, Shanghai Municipality, 201700

  • Shanghai third People's Hospital affliated to Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 201999

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blind and Placebo-controlled Clinical Research of 2200 Cases in Improving Curative Effect of Secondary Prevention for Patients With Ischemic Stroke Through Syndrome Differentiation of TCM

The purpose of this study is to assess the efficacy and safety of Naoxintong Capsule in the secondary prevention of ischemic stroke by the multi-center, randomized,double-blind，placebo-controlled trial design project.

Read the detailed description

The research employs a random, double-blind, multicenter, placebo parallel and controlled design to observe the clinical effect of Naoxintong capsule in the treatment in ischemic stroke of the blood stasis syndrome on the secondary prevention，which is funded by Science and Technology Commission of Shanghai Municipality.The therapeutic drug of the research is Naoxintong capsule on the market for treatment and prevention of stroke, applicable to stroke patients caused by qi deficiency, blood stasis and venation stasis.The research will be carried out in 24 hospitals.It is a total number of 2200 volunteers，who will meet the inclusion criteria other than the exclusion criteria and agree to participate in the research.Volunteers will be randomly assigned to the experimental group or the control group. The trial drug for the experimental group is Naoxintong capsule, while that for the control group is a kind of placebo capsule.Volunteers will be regularly followed up during the experimental period of 2 years. It will be to evaluate the clinical efficacy of Naoxintong capsule on the secondary prevention by the stroke recurrence and mortality.

Conditions
Ischemic Stroke
Being tested
Naoxintong Capsule, Placebo
Keywords
ischemic stroke；Naoxintong 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.

  • Naoxintong CapsuleDrug

    Also called Chinese Herbal Compound

    This is Naoxintong capsule,which is composed of Huangqi,Chishao,Danshen,Danggui, Chuanxiong,Taoren,Honghua,Ruxiang,Moyao,Jixueteng,Niuxi,Guizhi,Sangzhi,Dilong,Quanxie,etal.

  • PlaceboDrug

    Also called Placebo of Chinese Herbal Compound

    placebo capsule has the same as Naoxintong capsule in the appearance, shape,colour and content tinct.

Study groups in NCT02334969
Study groupRoleWhat they receive
Experimental groupExperimentalOn the basis of the secondary prevention of ischemic stroke，Volunteers will be taken Naoxintong capsule, 2 times a day, three granule per time
Receives: Drug: Naoxintong Capsule
Control groupActive comparatorOn the basis of the secondary prevention of ischemic stroke，Volunteers will be taken Placebo capsule，which is identical with Naoxintong capsule in the appearance, shape, color and content, 2 times a day, three granule per time
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stroke recurrence rate and Stroke mortality

    Stroke recurrence rate and Stroke mortality

    Measured: 2 years

Secondary outcomes (2)

  1. All-cause mortality

    All-cause mortality

    Measured: 2 years

  2. The incidence rate of myocardial infarction

    The incidence rate of myocardial infarction

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2015 (estimated)
  2. Study startApr 2016
  3. Primary completion30 Aug 2018
  4. Study completion30 Aug 2018

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
2,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02334969
Sponsor's protocol ID
14401970300
Status last verified
Nov 2018
First submitted
6 Jan 2015
Last updated
19 Nov 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002 Jan 12;324(7329):71-86. doi: 10.1136/bmj.324.7329.71.

    PubMed 11786451

  • Hankey GJ. Ischaemic stroke--prevention is better than cure. J R Coll Physicians Edinb. 2010 Mar;40(1):56-63. doi: 10.4997/JRCPE.2010.111. No abstract available.

    PubMed 21125042

  • Sobel M. Commentary. Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (ESPRIT): randomised controlled trial. Perspect Vasc Surg Endovasc Ther. 2007 Mar;19(1):87-9. doi: 10.1177/1531003507299489. No abstract available.

    PubMed 17437989

  • Matchar DB, Samsa GP, Liu S. Cost-effectiveness of antiplatelet agents in secondary stroke prevention: the limits of certainty. Value Health. 2005 Sep-Oct;8(5):572-80. doi: 10.1111/j.1524-4733.2005.00050.x.

    PubMed 16176495

  • Diener HC, Sacco RL, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, VanderMaelen C, Voigt T, Weber M, Yoon BW; Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) study group. Effects of aspirin plus extended-release dipyridamole versus clopidogrel and telmisartan on disability and cognitive function after recurrent stroke in patients with ischaemic stroke in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial: a double-blind, active and placebo-controlled study. Lancet Neurol. 2008 Oct;7(10):875-84. doi: 10.1016/S1474-4422(08)70198-4. Epub 2008 Aug 29.

    PubMed 18757238

  • Uchiyama S, Ikeda Y, Urano Y, Horie Y, Yamaguchi T. The Japanese aggrenox (extended-release dipyridamole plus aspirin) stroke prevention versus aspirin programme (JASAP) study: a randomized, double-blind, controlled trial. Cerebrovasc Dis. 2011;31(6):601-13. doi: 10.1159/000327035. Epub 2011 Apr 19.

    PubMed 21502757

  • Jeng JS, Sun Y, Lee JT, Lin RT, Chen CH, Po HL, Lin HJ, Liu CH, Sun MH, Sun MC, Chern CM, Lien LM, Chiu HC, Hu HH, Chiou HY, Chen ST, Ma H, Hsu CY; SPAD Study Investigators. The efficacy and safety of cilostazol in ischemic stroke patients with peripheral arterial disease (SPAD): protocol of a randomized, double-blind, placebo-controlled multicenter trial. Int J Stroke. 2015 Jan;10(1):123-7. doi: 10.1111/ijs.12384. Epub 2014 Nov 14.

    PubMed 25394855

  • Ikeda Y, Shimada K, Teramoto T, Uchiyama S, Yamazaki T, Oikawa S, Sugawara M, Ando K, Murata M, Yokoyama K, Ishizuka N. Low-dose aspirin for primary prevention of cardiovascular events in Japanese patients 60 years or older with atherosclerotic risk factors: a randomized clinical trial. JAMA. 2014 Dec 17;312(23):2510-20. doi: 10.1001/jama.2014.15690.

    PubMed 25401325

  • Yu XF, Zhu XY, Yuan CX, Wu DH, Zhao YW, Yang JJ, Wang CD, Wu WW, Liu XY, Liu ZG, Nie ZY, Deng BQ, Bao H, Li LX, Wang CY, Zhang HZ, Zhang JS, Huang JH, Gong F, Wang MZ, Guo YM, Sun Y, Cai DF. Naoxintong Capsule for Secondary Prevention of Ischemic Stroke: A Multicenter, Randomized, and Placebo-Controlled Trial. Chin J Integr Med. 2022 Dec;28(12):1063-1071. doi: 10.1007/s11655-022-3586-8. Epub 2022 Oct 17.

    PubMed 36251140

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Naoxintong Capsule in people with Ischemic Stroke, run by Xiaofei Yu at 24 sites 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 6 inclusion and 6 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 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites 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. 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?

Stroke recurrence rate and Stroke mortality (time frame: 2 years). 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 NCT02334969, which also lists 9 linked publications.

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 19 Nov 2018.

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