Pre-operative Antihypertension Strategies-Carotid Artery Stenting (PASS-CAS)

Sichuan University

Status and phase: Not yet enrolling; Phase 3

Conditions: Carotid Stenosis

Treatments: Drug: administering CCB (the trade name or universal name will not be stipulated) before stenting; Drug: administering RASI (the trade name or universal name will not be stipulated) before stenting

Study type: Interventional

Funder types: Other

Identifiers

NCT05905848

2023(728)

Details and patient eligibility

About

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.

Enrollment: 560 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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560 participants in 2 patient groups

RASI group

Experimental group

Description:

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.

Treatment:

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

CCB group

Active Comparator group

Description:

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.

Treatment:

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