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

NCT02334969 | Completed Phase 4 DMC

• 1 other identifier: 14401970300
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 24

Brief 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.

Conditions

Ischemic Stroke

Keywords

ischemic stroke；Naoxintong Capsule

Outcome Measures

Primary Outcomes (1)

• Stroke recurrence rate and Stroke mortality

  Stroke recurrence rate and Stroke mortality

  2 years

Secondary Outcomes (2)

• All-cause mortality

  2 years

• The incidence rate of myocardial infarction

  2 years

Other Outcomes (1)

• The incidence of adverse events

  2 years

Study Arms (2)

Experimental group

EXPERIMENTAL

On the basis of the secondary prevention of ischemic stroke，Volunteers will be taken Naoxintong capsule, 2 times a day, three granule per time

Drug: Naoxintong Capsule

Control group

ACTIVE COMPARATOR

On 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

Drug: Placebo

Interventions

Naoxintong Capsule DRUG

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

Also known as: Chinese Herbal Compound

Experimental group

Placebo DRUG

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

Also known as: Placebo of Chinese Herbal Compound

Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaofei Yu: lead
• Shanghai Municipal Science and Technology Commission: collaborator

Study Sites (24)

Shanghai seventh People's Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

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

Shanghai, Shanghai Municipality, 200011, China

Location

North Branch of Ruijin Hospital affliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200020, China

Location

Shanghai Putuo Central Hospital

Shanghai, Shanghai Municipality, 200021, China

Location

Shuguang Hospital affliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200021, China

Location

Longhua Hospital affliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

Location

Zhongshan Hospital affliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Huashan Hospital affliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai fifth People's Hospital affliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Tongren Hospital affliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200050, China

Location

Tongji Hospital

Shanghai, Shanghai Municipality, 200065, China

Location

Shanghai Chinese Medicine Hospital

Shanghai, Shanghai Municipality, 200071, China

Location

Shanghai tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Shanghai Hospital of Integrative Medicine

Shanghai, Shanghai Municipality, 200082, China

Location

Xinhua Hospital affliated to Shanghai Jiao Tong University Shool of Medcine

Shanghai, Shanghai Municipality, 200092, China

Location

Dongfang Hospital affliated to Tongji University

Shanghai, Shanghai Municipality, 200120, China

Location

Pudong Gong Li Hospital of Shanghai

Shanghai, Shanghai Municipality, 200135, China

Location

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

Shanghai, Shanghai Municipality, 200233, China

Location

Changning Tongren Hospital of Shanghai

Shanghai, Shanghai Municipality, 200336, China

Location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Pudong Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 201200, China

Location

East Branch of Shanghai sixth People's Hospital

Shanghai, Shanghai Municipality, 201306, China

Location

Qingpu Branch of Zhongshan Hospital affliated to Fudan University

Shanghai, Shanghai Municipality, 201700, China

Location

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

Shanghai, Shanghai Municipality, 201999, China

Location

Related Publications (9)

• 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.

  PMID: 11786451 RESULT

• 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.

  PMID: 21125042 RESULT

• 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.

  PMID: 17437989 RESULT

• 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.

  PMID: 16176495 RESULT

• 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.

  PMID: 18757238 RESULT

• 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.

  PMID: 21502757 RESULT

• 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.

  PMID: 25394855 RESULT

• 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.

  PMID: 25401325 RESULT

• 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.

  PMID: 36251140 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

naoxintong

Condition Hierarchy (Ancestors)

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

Study Officials

• Xiao F Yu, Doctor

  ShuGuang Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shuguang Hospital

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 9, 2015
• Study Start: April 1, 2016
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: November 19, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (24)