The Intra-arterial Vasospasm Trial

Phase 4

Recruiting

• Conditions: Cerebral Vasospasm
• Interventions: Drug: Nicardipine + Verapamil + Nitroglycerin; Drug: Nicardipine; Drug: Verapamil

• Registration Number: NCT01996436
• Lead Sponsor: Peng Roc Chen, MD

Brief Summary

The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome at 90 days post discharge following optimal intra-arterial drug treatment for cerebral vasospasm.

We hypothesize that Intra-arterial (IA) infusion of a combination of multiple vasodilators is more efficacious than single agent treatment cerebral vasospasm therapy.

All procedures done as a part of this study are standard hospital care procedures done to treat cerebral vasospasm and all drugs to be used are FDA approved.

Detailed Description

The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal subarachnoid hemorrhage.

The secondary objective is to evaluate clinical outcome at 90 days post discharge following optimal intra-arterial drug treatment for cerebral vasospasm.

This study is a prospective multicenter randomized trial. The primary outcome measure is the Post infusion improvement ratio (PIIR) assessed 10 minutes after completion of the intra-arterial infusion. PIIR is a measure of arterial lumen diameter pre and post intra-arterial drug infusion in the presenting vasospasmic blood vessel.

Modified Rankin score (mRS) at 3 months post hospital discharge will be recorded as a secondary outcome to assess clinical outcome.

The interventions in this study are a part of routine standard of care (SOC) procedures for cerebral vasospasm treatment. Following surgical or endovascular intervention for aneurysmal Subarachnoid Hemorrhage (aSAH) if patients develop cerebral vasospasm refractory to maximal medical management, endovascular treatment by intra-arterial drug infusion of single drug agent or cocktail drug agents will be initiated.

Study participants will be randomly assigned to one of the three treatment groups where one single drug agent or cocktail drug agents will be intra-arterially administered. Pre \& post infusion vasospasmic vessel diameters will be compared. The change in diameter will be quantified based on the mean percentage change. Three months post hospital discharge, study participants will be followed up in clinic to evaluate clinical outcome.

The study will require 330 patients in total. The patient population will be hospitalized patients presenting with cerebral vasospasm post aneurysmal subarachnoid hemorrhage.

Subjects will be stratified by randomization into 3 treatment groups.

Study Timeline

• Study First Submitted: 2013-11-12
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-27
• Study Start: 2016-08-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12
• Primary Completion: 2024-08
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Adult patient, age 18-80 years old, with ruptured aneurysm(s) who experience cerebral vasospasm post operatively within 3-21 days.
• Symptomatic vasospasm (clinical or TCD)
• For centers that perform a routine day 7 angiogram post-aneurysm treatment - 50% or more stenosis seen on diagnostic angiogram for asymptomatic patients.

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Exclusion Criteria

• Inability to obtain consent from patient or patients kin
• Pregnant women
• less than 18 years of age of more than 80 years of age
• Hunt Hess Grade 5 SAH
• Intra-arterial drug treatment in all 3 arterial territories

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicardipine + Verapamil + Nitroglycerin	Nicardipine + Verapamil + Nitroglycerin	Group 4 : Nicardipine 5mg + Verapamil 10mg + Nitroglycerin 200mcg in 4cc 5 % dextrose in water , intra-arterial injection, Pharmacological angioplasty
Nicardipine	Nicardipine	Group 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty
Verapamil	Verapamil	Group 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty

Primary Outcome Measures

Name	Time	Method
Post infusion improvement ratio(PIIR)	pre pharmacological angioplasty blood vessel diameter - 0 min, post pharmacological angioplasty blood vessel diameter- 10 min after infusion	Post infusion improvement ratio(PIIR) = (B - A) / A; A = pre-infusion blood vessel diameter B = post infusion blood vessel diameter; PIIR across all four treatment arms will be compared and tested for statistical significance.

Secondary Outcome Measures

Name	Time	Method
To grade clinical outcome using Modified Rankin score	3 months post discharge from hospital	Clinical outcome at 3 months post discharge from hospital after treatment will be evaluated using Modified Rankin score

Trial Locations

Locations (10)

Northwell Health; 🇺🇸 Manhasset, New York, United States

Geisinger Clinic; 🇺🇸 Danville, Pennsylvania, United States

University of Illinois College of Medicine at Chicago; 🇺🇸 Chicago, Illinois, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

Lenox Hill; 🇺🇸 New York, New York, United States

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

University of Texas Medical School at Houston; 🇺🇸 Houston, Texas, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States