Pre-operative Antihypertension Strategies-Carotid Artery Stenting

NCT ID: NCT05905848

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2025-07-31

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.

Detailed Description

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Conditions

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Carotid Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RASI group and CCB group
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
open label, blinded endpoint

Study Groups

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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.

Group Type EXPERIMENTAL

administering RASI (the trade name or universal name will not be stipulated) before stenting

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

administering CCB (the trade name or universal name will not be stipulated) before stenting

Intervention Type DRUG

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.

Interventions

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administering RASI (the trade name or universal name will not be stipulated) before stenting

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.

Intervention Type DRUG

administering CCB (the trade name or universal name will not be stipulated) before stenting

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.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bo Wu

Professor/Deputy Director of Neurology of West China Hospital, Sichuan University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Wu, Dr

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

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West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

Countries

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China

Central Contacts

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Bo Wu, Dr

Role: CONTACT

+8618980602142

Facility Contacts

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Bo Wu, Dr

Role: primary

+8618980602142

Le Cao, Dr

Role: backup

+8613035693059

Other Identifiers

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2023(728)

Identifier Type: -

Identifier Source: org_study_id

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