Clinical trial NCT05905848: Pre-operative Antihypertension Strategies-Carotid Artery Stenting
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Carotid Stenosis
Keywords: Carotid Artery Stenting
Sinus Reflex
Antihypertensive drugs
Catecholamine
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RASI group and CCB group
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The incidence of persistent post-surgery hypotension
timeFrame: the first 24 hours after CAS
Secondary outcomes:
measure: Length of stay after surgery
timeFrame: From surgery to dicharge, up to 3 month.
measure: Hospital expenses after surgery, based on payment list in hospital information system
timeFrame: From surgery to dicharge, up to 3 month.
measure: Difference of serum catecholamine (adrenalin, norepinephrine and dopamine) before and after surgery (all in unit of nmol/L)
timeFrame: at morning (7 o'clock am) of the day of surgery and the first day after surgery
measure: Difference of heart rate variability (HRV) before and after surgery
timeFrame: 24 hours before surgery to at least 24 hours after surgery
measure: The incidence of bradycardia after surgery
timeFrame: the first 24 hours after CAS
measure: The total incidence of stroke, myocardial infraction, renal failure and embolism of retinal arteries
timeFrame: From surgery to dicharge, up to 3 month.
Other outcomes:
measure: The total incidence of cardiac and cerebral events (stroke, myocardial infarction, heart failure and angina pectoris) and symptomatic hypotension
timeFrame: From administering antihypertensive drugs to stenting, at least 5 days
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Bo Wu, Dr
role: PRINCIPAL_INVESTIGATOR
References: