Risk Assessment Model for Ischemic Stroke Endpoint Events

NCT03174535 | Completed DMC

• 1 other identifier: 201507003-8
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to develope a risk assessment model of ischemic stroke endpoint events combining multi-dimensional traditional Chinese medicine(TCM) indicators with modern medicine indicators. The proposed study is a registry study based participant survey conducted in 7 hospitals nationwide in China. After obtaining informed consent, a total of 3000 study patients diagnosed with ischemic stroke will be recruited. 1-year follow-ups are carried out on-site in hospitals and by telephone to track endpoint events. At the same time, we conducted a prospective, multicenter, real-world longitudinal cohort study at 7 hospitals in China to investigate the clinical effectiveness of Qilong capsule (QLC) combined with CT for IS with Qi deficiency and blood stasis syndrome.

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke; Secondary Prevention; Endpoint Events; Risk Assessment; Traditional Chinese Medicine; Registry Study; Clinical effectiveness; Cohort study

Outcome Measures

Primary Outcomes (2)

• ischemic stroke recurrence events

  Including cerebral infarction, cerebral hemorrhage and TIA

  1 year follow-up

• mRS, NIHSS, BI

  modified Rankin Scale (mRS), the National Institute of Health Stroke Scale (NIHSS), and the Barthel Index (BI)

  All participants returned for in-person follow-up visits at the 12th week and 24th week.

Secondary Outcomes (2)

• death, disability, and endpoint events of atherosclerotic cardiovascular disease and atherosclerotic peripheral vascular disease

  1 year follow-up

• TCM syndromes, psychological index, blood lipid index,blood coagulation index, and homocysteine

  All participants returned for in-person follow-up visits at the 12th week and 24th week.

Study Arms (2)

Exposure group

The exposure group was the patients who were treated with Qilong capsules (QLC). The willingness of the patients and the objective judgment of the clinician were comprehensively considered to decide whether to use QLC for intervention. Patients who chose to use QLC for intervention would take it immediately after being deemed eligible for enrollment. The recommended dosage of QLC was 0.4g each time, 3 times a day. The course of treatment was 12 weeks. QLC was produced by Jining Huaneng Pharmaceutical Factory Co., Ltd. All participants in the exposure groups received the standard level of CT provided by clinicians according to the clinical diagnosis and treatment guidelines for IS, including antiplatelet aggregation drugs, antihypertensive drugs, hypoglycemic drugs, and lipid-lowering drugs.

Drug: Qilong capsules (QLC), produced by Jining Huaneng Pharmaceutical Factory Co., Ltd.

Non-exposure group

The non-exposure group was the patients who did not take QLC. All participants in the non-exposure groups received the standard level of CT provided by clinicians according to the clinical diagnosis and treatment guidelines for IS, including antiplatelet aggregation drugs, antihypertensive drugs, hypoglycemic drugs, and lipid-lowering drugs.

Interventions

Qilong capsules (QLC), produced by Jining Huaneng Pharmaceutical Factory Co., Ltd. DRUG

The recommended dosage of QLC was 0.4g each time, 3 times a day. The course of treatment was 12 weeks.

Exposure group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be comprised of those who meet all inclusion criteria and no exclusion or elimination criteria. Study personnel will continuously screen eligible patients presenting to the hospitals until the sample size of 3000 is reached. This study will be conducted in 7 hopitals nationwide in China, including Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing Tian Tan Hospital affiliated to Capital Medical University, Guangdong Provincial Hospital of TCM, Affiliated Hospital of Changchun University of Chinese Medicine, the first Hospital Affiliated to Henan University of TCM, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, and Taiyuan Municipal Hospital of TCM.

You may qualify if:

• (1) Meeting diagnostic criteria of ischemic stroke; (2) Meeting large-artery atherosclerosis or small-artery occlusion subtypes of ischemic stroke according to TOAST (The Trial of Org 10172 in Acute Stroke Treatment) classification \[29\]; (3) In the first 2 weeks of the first onset should account for no less than 50% of all the included cases; (4) 38-80 years of age; (5) Willing to respond truthfully and timely to researcher queries after recruitment, able to cooperate with data and sample collection during follow-ups; (6) Willing to sign informed consent.

You may not qualify if:

• (1) Meeting diagnostic criteria of transient ischemic attack (TIA), hemorrhagic stroke, or mixed stroke; (2) Meeting cardioembolism, other determined or undetermined etiology subtypes of ischemic stroke according to TOAST classification \[29\]; (3) Unable to participate in data or sample collection for any reason.

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Yanming Xie

Beijing, Beijing Municipality, 100700, China

Location

Related Publications (3)

• Lyu J, Liu Y, Liu F, Liu G, Gao Y, Wei R, Cai Y, Shen X, Zhao D, Zhao X, Xie Y, Yu H, Chai Y, Zhang J, Zhang Y, Xie Y. Therapeutic effect and mechanisms of traditional Chinese medicine compound (Qilong capsule) in the treatment of ischemic stroke. Phytomedicine. 2024 Sep;132:155781. doi: 10.1016/j.phymed.2024.155781. Epub 2024 Jun 2.

  PMID: 38870749 DERIVED

• Lyu J, Gao Y, Wei R, Cai Y, Shen X, Zhao D, Zhao X, Xie Y, Yu H, Chai Y, Xie Y. Clinical effectiveness of Qilong capsule in patients with ischemic stroke: A prospective, multicenter, non-randomized controlled trial. Phytomedicine. 2022 Sep;104:154278. doi: 10.1016/j.phymed.2022.154278. Epub 2022 Jun 15.

  PMID: 35780589 DERIVED

• Gao Y, Xie YM, Wang GQ, Cai YF, Shen XM, Zhao DX, Xie YZ, Zhang Y, Meng FX, Yu HQ, Jiang JJ, Wei RL. Onset and Recurrence Characteristics of Chinese Patients with Noncardiogenic Ischemic Stroke in Chinese Medicine Hospital. Chin J Integr Med. 2022 Jun;28(6):492-500. doi: 10.1007/s11655-022-3306-4. Epub 2022 Mar 8.

  PMID: 35258782 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen includes serum, blood clots and whole blood.

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Qilong; Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Yanming Xie, M.D.

  China Academy of Chinese Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 2, 2017
• Study Start: November 15, 2016
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2019
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)