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

Primary Purpose

Carotid Stenosis

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
administering RASI (the trade name or universal name will not be stipulated) before stenting
administering CCB (the trade name or universal name will not be stipulated) before stenting
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Carotid Stenosis focused on measuring Carotid Artery Stenting, Sinus Reflex, Antihypertensive drugs, Catecholamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • West China Hospital, Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RASI group

CCB group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of stay after surgery
Hospital expenses after surgery, based on payment list in hospital information system
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.
Difference of serum catecholamine (adrenalin, norepinephrine and dopamine) before and after surgery (all in unit of nmol/L)
Difference of heart rate variability (HRV) before and after surgery
The incidence of bradycardia after surgery
The total incidence of stroke, myocardial infraction, renal failure and embolism of retinal arteries

Full Information

First Posted
May 30, 2023
Last Updated
June 7, 2023
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05905848
Brief Title
Pre-operative Antihypertension Strategies-Carotid Artery Stenting
Acronym
PASS-CAS
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 15, 2023 (Anticipated)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis
Keywords
Carotid Artery Stenting, Sinus Reflex, Antihypertensive drugs, Catecholamine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
RASI group and CCB group
Masking
Outcomes Assessor
Masking Description
open label, blinded endpoint
Allocation
Randomized
Enrollment
560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RASI group
Arm Type
Experimental
Arm 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.
Arm Title
CCB group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
administering RASI (the trade name or universal name will not be stipulated) before stenting
Intervention Description
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
Intervention Name(s)
administering CCB (the trade name or universal name will not be stipulated) before stenting
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of persistent post-surgery hypotension
Description
systolic blood pressure (SBP) < 90 mmHg or requiring vasopressor with lasting > 6 hours, and without evidence hypovolemia and heart failure
Time Frame
the first 24 hours after CAS
Secondary Outcome Measure Information:
Title
Length of stay after surgery
Time Frame
From surgery to dicharge, up to 3 month.
Title
Hospital expenses after surgery, based on payment list in hospital information system
Description
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.
Time Frame
From surgery to dicharge, up to 3 month.
Title
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
Title
Difference of heart rate variability (HRV) before and after surgery
Time Frame
24 hours before surgery to at least 24 hours after surgery
Title
The incidence of bradycardia after surgery
Time Frame
the first 24 hours after CAS
Title
The total incidence of stroke, myocardial infraction, renal failure and embolism of retinal arteries
Time Frame
From surgery to dicharge, up to 3 month.
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Wu, Dr
Phone
+8618980602142
Email
dr.bowu@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Wu, Dr
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Wu, Dr
Phone
+8618980602142
Email
dr.bowu@hotmail.com
First Name & Middle Initial & Last Name & Degree
Le Cao, Dr
Phone
+8613035693059
Email
lec445477@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Pre-operative Antihypertension Strategies-Carotid Artery Stenting

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