Pre-operative Antihypertension Strategies-Carotid Artery Stenting

Carotid Stenosis Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05905848
• Other study ID #: 2023(728)
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 15, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2023
• Source: West China Hospital
• Contact: Bo Wu, Dr
• Phone: +8618980602142
• Email: dr.bowu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 560
• Est. completion date: July 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Stenosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Length of stay after surgery		From surgery to dicharge, up to 3 month.
Secondary	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.	From surgery to dicharge, up to 3 month.
Secondary	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
Secondary	Difference of heart rate variability (HRV) before and after surgery		24 hours before surgery to at least 24 hours after surgery
Secondary	The incidence of bradycardia after surgery		the first 24 hours after CAS
Secondary	The total incidence of stroke, myocardial infraction, renal failure and embolism of retinal arteries		From surgery to dicharge, up to 3 month.