Carotid StenosisPhase 3PASS-CASNCT05905848
Pre-operative Antihypertension Strategies-Carotid Artery Stenting
A Phase 3 study testing administering RASI (the trade name or universal name will not be stipulated) before stenting and administering CCB (the trade name or universal name will not be stipulated) before stenting in people with Carotid Stenosis, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- administering RASI (the trade name or universal name will not be stipulated) before stenting and administering CCB (the trade name or universal name will not be stipulated) before stenting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2023to 31 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
China1 site
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Bo Wu, Dr, +8618980602142, dr.bowu@hotmail.com
Le Cao, Dr, +8613035693059, lec445477@gmail.com
About this study
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
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
- Being tested
- 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
- Keywords
- Carotid Artery Stenting, Sinus Reflex, Antihypertensive drugs, Catecholamine
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administering RASI (the trade name or universal name will not be stipulated) before stentingDrug
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.
administering CCB (the trade name or universal name will not be stipulated) before stentingDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: administering CCB (the trade name or universal name will not be stipulated) before stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: the first 24 hours after CAS
Secondary outcomes (6)
Length of stay after surgery
Measured: From surgery to dicharge, up to 3 month.
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.
Measured: 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)
Measured: 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
Measured: 24 hours before surgery to at least 24 hours after surgery
The incidence of bradycardia after surgery
Measured: the first 24 hours after CAS
The total incidence of stroke, myocardial infraction, renal failure and embolism of retinal arteries
Measured: From surgery to dicharge, up to 3 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 Jun 2023 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RASI group and CCB group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Wu, West China Hospital
- Investigators
- Bo Wu, Dr, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905848
- Sponsor's protocol ID
- 2023(728)
- Acronym
- PASS-CAS
- Status last verified
- Jun 2023
- First submitted
- 30 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Outcomes and grouping of patticipants will be shared to all investigators contributing to this study. Study protocol, statistical analysis plan will also be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05905848
- Acronym / sponsor ID
- PASS-CAS / 2023(728)
- Conditions
- Carotid Stenosis
- Keywords
- Carotid Artery Stenting, Sinus Reflex, Antihypertensive drugs, Catecholamine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RASI group and CCB group
| Arm | Type | Receives |
|---|---|---|
| RASI group | Experimental | Drug: administering RASI (the trade name or universal name will not be stipulated) before stentingAdminister 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. |
| CCB group | Active comparator | Drug: administering CCB (the trade name or universal name will not be stipulated) before stentingAdminister 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| administering RASI (the trade name or universal name will not be stipulated) before stentingPre-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. | Drug | RASI group |
| administering CCB (the trade name or universal name will not be stipulated) before stentingPre-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. | Drug | CCB group |
Primary outcome
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
6 secondary outcomes
Length of stay after surgery
Time frame: 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.
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
Difference of heart rate variability (HRV) before and after surgery
Time frame: 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 total incidence of stroke, myocardial infraction, renal failure and embolism of retinal arteries
Time frame: From surgery to dicharge, up to 3 month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: Yes. Outcomes and grouping of patticipants will be shared to all investigators contributing to this study. Study protocol, statistical analysis plan will also be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Wu, Dr principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing administering RASI (the trade name or universal name will not be stipulated) before stenting and administering CCB (the trade name or universal name will not be stipulated) before stenting in people with Carotid Stenosis, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Wu, Dr (+8618980602142, dr.bowu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of persistent post-surgery hypotension (time frame: the first 24 hours after CAS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.