Pre-operative Antihypertensive Drugs and Persistent Hypotension in Carotid Artery Stenting Comorbid With Hypertension Patients --- a Multicenter, Randomized, Open Label, Blinded Ended Point Clinic Trail
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- The incidence of persistent post-surgery hypotension
研究概览
简要总结
Carotid artery stenting (CAS) is one of major treatments in prevention of ischemic stroke. Because of sinus reflex due to stenting and balloon dilatation, persistent post-surgery hypotension is a common perioperative event. Persistent hypotension can lead to perioperative adverse events like ischemic stroke, myocardial infraction, renal failure and death; or more usually, it prolongs length of stay and hospital expenses. Renin-angiotensin-aldosterone inhibitor (RASI) could inhibit the release of catecholamine and may lead to higher rate of persistent hypotension after CAS compared to other hypertensives.Thus, the investigators aim to investigate the effect of pre-operation antihypertensive drugs on persistent hypotension after stenting, and followed burden in carotid artery stenting comorbid with hypertension patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
open label, blinded endpoint
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have a history of TIA or nondisabling ischemic stroke within the past 6 months (symptomatic) with ipsilateral initial part of EICA stenosis ≥ 50 % or asymptomatic with initial part of EICA stenosis ≥ 70%, and the cause of stenosis was atherosclerosis
- •have hypertension requiring hypertensives
- •modified Rankin scale (mRS) before stenting < 3
排除标准
- •with ipsilateral tandem stenosis
- •with history of operation in contralateral carotid artery, like stenting, endarterectomy and bypass.
- •requiring operation in contralateral carotid artery in the same admission.
- •requiring general anesthesia in the same operation (stenting)
- •with contraindication to carotid stenting, such as Inability to tolerate surgery due to organ dysfunction, cerebral aneurism, cerebral hemorrhage in 3 months, myocardial infraction or large-area cerebral infraction within 2 weeks, extreme tortuosity of the vessel
- •allergic to Calcium channel blockers, angiotensin receptor blockers or hydrochlorothiazide
- •pregnancy
- •with concomitant medication as following: Azole antifungals, macrolides antibiotics, cardiac calcium channel blockers, Rifampicin, sildenafil, simvastatin, immunosuppressants, antidepressants, valproic acid, cimetidine, aliskiren, NSAIDs, protease inhibitors (ritonavir) and drugs that affect potassium in the blood
- •with hepatic insufficiency, renal insufficiency, kidney transplantation, diabetic nephropathy, biliary obstructive disease, or the presence of end-stage disease affecting clinical prognosis assessment (such as end-stage cancer, end-stage heart disease, liver failure, renal failure, pulmonary failure)
- •with depression, schizophrenia, bipolar disorder, epilepsy, tuberculosis, AIDS, primary hyperaldosteronism, hyperkalemia, hypercalcemia, hyperuricemia, gout
- •participating other trails which would affect the evaluation of outcomes
- •with reserpine and clonidine intake within 1 week
研究组 & 干预措施
RASI group
Administer RASI, with or without other antihypertensives except for CCB, and blood pressure should be controlled within the target range (140/90 mmHg). RASI intaking starts at least 5 days before stenting.
干预措施: administering RASI (the trade name or universal name will not be stipulated) before stenting (Drug)
CCB group
Administer CCB, with or without other antihypertensives except for RASI, and blood pressure should be controlled within the target range (140/90 mmHg). CCB intaking starts at least 5 days before stenting.
干预措施: administering CCB (the trade name or universal name will not be stipulated) before stenting (Drug)
结局指标
主要结局
The incidence of persistent post-surgery hypotension
时间窗: the first 24 hours after CAS
systolic blood pressure (SBP) \< 90 mmHg or requiring vasopressor with lasting \> 6 hours, and without evidence hypovolemia and heart failure
次要结局
- Length of stay after surgery(From surgery to dicharge, up to 3 month.)
- Hospital expenses after surgery, based on payment list in hospital information system(From surgery to dicharge, up to 3 month.)
- Difference of serum catecholamine (adrenalin, norepinephrine and dopamine) before and after surgery (all in unit of nmol/L)(at morning (7 o'clock am) of the day of surgery and the first day after surgery)
- Difference of heart rate variability (HRV) before and after surgery(24 hours before surgery to at least 24 hours after surgery)
- The incidence of bradycardia after surgery(the first 24 hours after CAS)
- The total incidence of stroke, myocardial infraction, renal failure and embolism of retinal arteries(From surgery to dicharge, up to 3 month.)
研究者
Bo Wu
Professor/Deputy Director of Neurology of West China Hospital, Sichuan University
West China Hospital