Pre-operative Antihypertension Strategies-Carotid Artery Stenting

NCT05905848 | Unknown Phase 3 DMC

• 1 other identifier: 2023(728)
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Stenosis

Keywords

Carotid Artery Stenting; Sinus Reflex; Antihypertensive drugs; Catecholamine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Other Outcomes (1)

• The total incidence of cardiac and cerebral events (stroke, myocardial infarction, heart failure and angina pectoris) and symptomatic hypotension

  From administering antihypertensive drugs to stenting, at least 5 days

Study Arms (2)

RASI group

EXPERIMENTAL

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

CCB group

ACTIVE COMPARATOR

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

Interventions

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

RASI group

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

CCB group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bo Wu, Dr

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Wu, Dr

CONTACT

+8618980602142; dr.bowu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: open label, blinded endpoint
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Deputy Director of Neurology of West China Hospital, Sichuan University

Model Details: RASI group and CCB group

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 15, 2023
• Study Start: June 15, 2023
• Primary Completion: May 31, 2025
• Study Completion: July 31, 2025
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: from 6 month after the recruitment completed

Locations

CN (1)