Pre-operative Antihypertension Strategies-Carotid Artery Stenting

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Carotid Stenosis

Intervention / Treatment
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* Drug: administering RASI (the trade name or universal name will not be stipulated) before stenting
* Drug: administering CCB (the trade name or universal name will not be stipulated) before stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: RASI group and CCB group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RASI group<br>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. | Drug: administering RASI (the trade name or universal name will not be stipulated) before stenting<br>* Pre-operative antihypertensive drugs before stenting will be random assigned (RASI or CCB) at least 5 days before stenting. Patients in RASI group will receive RASI (all kinds of RASI will be permited and the trade name or universal name of drugs will not be limited), with or without other antihypertensives except for CCB (any kind of CCB). Blood pressure of patients should be controlled within the target range (140/90 mmHg); and usage and dosage of antihypertensive drugs will not be stipulated. Grapefruit intaking should be avoid.<br>|
| Active Comparator: CCB group<br>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. | Drug: administering CCB (the trade name or universal name will not be stipulated) before stenting<br>* Pre-operative antihypertensive drugs before stenting will be random assigned (RASI or CCB) at least 5 days before stenting. Patients in CCB group will receive CCB (all kinds of CCB will be permited and the trade name or universal name of drugs will not be limited), with or without other antihypertensives except for RASI (any kind of RASI). Blood pressure of patients should be controlled within the target range (140/90 mmHg); and usage and dosage of antihypertensive drugs will not be stipulated. Grapefruit intaking should be avoid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of persistent post-surgery hypotension | systolic blood pressure (SBP) < 90 mmHg or requiring vasopressor with lasting > 6 hours, and without evidence hypovolemia and heart failure | the first 24 hours after CAS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Payment list in hospital information system for all patients will be recorded with permission and the hospital expenses after surgery will be caculated based on those records. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carotid Artery Stenting, Sinus Reflex, Antihypertensive drugs, Catecholamine