Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke

Study Overview
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Brief Summary
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This study evaluate the effects of acupuncture method on the recurrence of ischemic stroke patients.Half of participants will receive Huo Xue San Feng acupuncture combining 1 antihypertensive medication on the routine ischemic stroke treatments' basis. While the other half will receive 1 antihypertensive medication and basic treatments for ischemic stroke.

Detailed Description
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Under recuiting 480 patients come from 5 hospitals in China.Eligible patients will be randomly assigned into 2 groups: treatment group and control group. The treatment group will receive Huo Xue San Feng acupuncture combining 1 antihypertensive medication on the routine ischemic stroke treatments' basis. The control group will receive 1 antihypertensive medication and basic treatments for ischemic stroke. Huo Xue San Feng acupuncture will be given six sessions weekly for the first 6 weeks and three times weekly for the next 6 weeks. A 9-month follow-up will thereafter be conducted. Antihypertensive medications will be adjusted based on BP levels.

Official Title
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Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke: Study Protocol for a Multicenter, Pragmatic,Randomized Controlled, Assessor-blinded Clinical Trial

Conditions
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Cerebral Infarction

Intervention / Treatment
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* Device: acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with the first time ischemic stroke Patients meet the TCM diagnosis standard of Stroke Patients meet the diagnosis standard of hypertension, taking only 1 type of antihypertensive drugs for at least 2 weeks before admission,corresponding to systolic pressure ranging from 140 to 160mmHg and Diastolic ranging from 90-100mmHg. The course of Ischemic stroke ranging from 2 weeks to 6 weeks . Men or Women Aged between 35 and 70 years old. Patients who are willing to participate in our clinical trial agree to sign the informed consent form. Exclusion Criteria: Patients who have been diagnosed with secondary hypertension. Patients have taken beta blockers or diuretics or non dihydropyridine calcium channel blocker （NDHP-CCB）for a long time because of cardiovascular disease. Patients who taking 1 type of antihypertensive drugs,blood pressure under 140/90mmHg. Patients accompanied with other neurological disorders,such as epilepsy, peripheral nerve injury, Patients accompanied with severe medical condition such as severe hematopoietic system disease, coagulation dysfunction and malignant tumor. Patients accompanied with diabetic nephropathy,severe liver and renal insufficiency,severe cardiac or pulmonary dysfunction,severe arrhythmia. Patients who have occured skin infections near the acupoint location. Pregnant or breast-feeding women. Patients who currently participate in another clinical trial.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Participants will recieve the therapy as follows: Huo Xue San Feng acupuncture method+Routine care for ischemic stroke+One type of antihypertensive medication. Intervention:Acupuncture(choosing the bilatral acupoint: Renying(ST9),Hegu(L14), Taichong(LR3),Quchi(LI11),Zusanli(ST36))+Drugs(one type of antihypertensive medicine) | Device: acupuncture<br>* Huo Xue San Feng acupuncture method: Patients will recieve the acupuncture treatment,choose the bilateral point:Renying(ST9),Hegu(L14),Taichong(LR3),Quchi(LI11),Zusanli(ST36). Routine care for ischemic stroke :patients will recieve the acupuncture treatment,choose the point:Neiguan(PC6),Renzhong(10),Sanyinjiao(SP6),Jiquan(HT1),Chize(LU5),Weizhong(BL40). Drugs: Antihypertensive drugs.Patients will be treated 1 of 5 type of antihypertensive drugs,include ARB、ACEI、βreceptor blocker,CCB,Diuretic. The time of therapy will consist of 6 times per week in Continuous treatment phase(1st-6th week after enrollment) and 3 times per week(once every other day) in Consolidation treatment phase(7th-tewlve week after enrollment)<br>* Other names: drug;|
| No Intervention: Control Group<br>Participants recieve the therapy as follows:Routine care for ischemic stroke +One type of antihypertensive medication. Intervention:Acupuncture(choosing the acupoint: Neiguan(PC6),Renzhong(10), Sanyinjiao(SP6),Jiquan(HT1),Chize(LU5),Weizhong(BL40).)+Drugs(one type of antihypertensive medicine) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effects of Acupuncture on Reccurence of Ischemic Stroke | The effects of acupuncture on reccurence of ischemic stroke assessed by China's Guidelines of Diagnosis and Treatment of Acute Ischemic Stroke 2014 and China's Guidelines of Diagnosis and Treatment of Cerebral Hemorrhage 2014. | 1 year after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour ambulatory blood pressure |  | the first day、6 weeks、12 weeks after enrollment | 
| Daily Blood Pressure by Electronic Sphygmomanometer |  | 1 year after enrollment | 
| Antihypertensive Drug Stop/Resumption/Increasing Rate |  | 1 year after enrollment | 
| Nitric Oxide(NO) |  | the first day、12 weeks,6 months after enrollment | 
| Endothelin(ET) |  | the first day、12 weeks,6 months after enrollment | 
| The Cardiac Color Doppler Ultrasonography |  | the first day、12 weeks after enrollment | 
| Carotid Color Ultrasonography |  | the first day、12 weeks after enrollment | 
| Brain Color Doppler Ultrasonography |  | the first day、12 weeks after enrollment | 
| Lower Extremity Color Ultrasonography |  | the first day、12 weeks after enrollment | 
| TCM syndrome score |  | the first day、6 weeks、12 weeks after enrollment | 
| Short Form 36-item Health Survey (SF-36) |  | the first day、6 weeks、12 weeks after enrollment | 
| National Institute of Health stroke scale (NIHSS)，as well as Barthel Index (BI) scale |  | the first day、12 weeks after enrollment | 
| Essen stroke risk score (ESRS) |  | the first day、1 year after enrollment | 
| All-caused Morality |  | 1 year after enrollment | 
| Serum homocysteine（Hcy） |  | the first day、12 weeks,6 months after enrollment | 
| Soluble CD40L（sCD40L） |  | the first day、12 weeks,6 months after enrollment | 
| Copeptin |  | the first day、12 weeks,6 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Hypertension, Second prevention of Stroke, Efficacy, RCT, Study protocol