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

June 7, 2023 updated by: Bo Wu, West China Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

560

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of persistent post-surgery hypotension
Time Frame: the first 24 hours after CAS
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
Time Frame: From surgery to dicharge, up to 3 month.
From surgery to dicharge, up to 3 month.
Hospital expenses after surgery, based on payment list in hospital information system
Time Frame: From surgery to dicharge, up to 3 month.
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)
Time Frame: at morning (7 o'clock am) of the day of surgery and the first day after surgery
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
Time Frame: 24 hours before surgery to at least 24 hours after surgery
24 hours before surgery to at least 24 hours after surgery
The incidence of bradycardia after surgery
Time Frame: the first 24 hours after CAS
the first 24 hours after CAS
The total incidence of stroke, myocardial infraction, renal failure and embolism of retinal arteries
Time Frame: From surgery to dicharge, up to 3 month.
From surgery to dicharge, up to 3 month.

Other Outcome Measures

Outcome Measure
Time Frame
The total incidence of cardiac and cerebral events (stroke, myocardial infarction, heart failure and angina pectoris) and symptomatic hypotension
Time Frame: From administering antihypertensive drugs to stenting, at least 5 days
From administering antihypertensive drugs to stenting, at least 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Investigators

  • Principal Investigator: Bo Wu, Dr, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2023

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023(728)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Outcomes and grouping of patticipants will be shared to all investigators contributing to this study. Study protocol, statistical analysis plan will also be shared.

IPD Sharing Time Frame

from 6 month after the recruitment completed

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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