NCT05905848

Pre-operative Antihypertension Strategies-Carotid Artery Stenting

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-06-15
• Primary completion: 2025-05-31
• Completion: 2025-07-31
• First posted: 2023-06-15
• Last updated: 2023-06-15

Locations

1 site across 1 country: China