Clinical trial NCT02967484: Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke
Official title: Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke: Study Protocol for a Multicenter, Pragmatic,Randomized Controlled, Assessor-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Infarction
Keywords: Acupuncture
Hypertension
Second prevention of Stroke
Efficacy
RCT
Study protocol
Lead sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: State Administration of Traditional Chinese Medicine of the People's Republic of China
First posted: 2016-11-18
Enrollment: 480
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Effects of Acupuncture on Reccurence of Ischemic Stroke
timeFrame: 1 year after enrollment
Secondary outcomes:
measure: 24-hour ambulatory blood pressure
timeFrame: the first day、6 weeks、12 weeks after enrollment
measure: Daily Blood Pressure by Electronic Sphygmomanometer
timeFrame: 1 year after enrollment
measure: Antihypertensive Drug Stop/Resumption/Increasing Rate
timeFrame: 1 year after enrollment
measure: Nitric Oxide(NO)
timeFrame: the first day、12 weeks,6 months after enrollment
measure: Endothelin(ET)
timeFrame: the first day、12 weeks,6 months after enrollment
measure: The Cardiac Color Doppler Ultrasonography
timeFrame: the first day、12 weeks after enrollment
measure: Carotid Color Ultrasonography
timeFrame: the first day、12 weeks after enrollment
measure: Brain Color Doppler Ultrasonography
timeFrame: the first day、12 weeks after enrollment
measure: Lower Extremity Color Ultrasonography
timeFrame: the first day、12 weeks after enrollment
measure: TCM syndrome score
timeFrame: the first day、6 weeks、12 weeks after enrollment
measure: Short Form 36-item Health Survey (SF-36)
timeFrame: the first day、6 weeks、12 weeks after enrollment
measure: National Institute of Health stroke scale (NIHSS)，as well as Barthel Index (BI) scale
timeFrame: the first day、12 weeks after enrollment
measure: Essen stroke risk score (ESRS)
timeFrame: the first day、1 year after enrollment
measure: All-caused Morality
timeFrame: 1 year after enrollment
measure: Serum homocysteine（Hcy）
timeFrame: the first day、12 weeks,6 months after enrollment
measure: Soluble CD40L（sCD40L）
timeFrame: the first day、12 weeks,6 months after enrollment
measure: Copeptin
timeFrame: the first day、12 weeks,6 months after enrollment
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Traditional Chinese Medicine Hospital
city: Mianyang
country: China
facility: MIANYANG Hospital of Traditional Chinese Medicine
city: Shanghai
country: China
facility: LONGHUA Hospital Shanghai University of Traditional Chinese Medicine
city: Shenzhen
country: China
facility: Shenzhen Bao'an Traditional Chinese Medicine Hospital Group
city: Tianjin
country: China
facility: First Teaching Hospital of Tianjin University of TCM
Study officials:
affiliation: The First Teaching Hospital of Tianjin University of TCM
name: Xuemin Shi
role: STUDY_DIRECTOR
References:
citation: Du YZ, Gao XX, Wang CT, Zheng HZ, Lei Y, Wu MH, Shi XM, Ban HP, Gu WL, Meng XG, Wei MT, Hu CX. Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial. Trials. 2017 Sep 15;18(1):428. doi: 10.1186/s13063-017-2171-5.