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Calcium Channel Blocker

Intra-arterial Drug Therapy for Cerebral Vasospasm (iVAST Trial)

Phase 4

Recruiting

Led By Ketan R Bulsara, MD

Research Sponsored by Peng Roc Chen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Intra-arterial drug treatment in all 3 arterial territories

Less than 18 years of age or more than 80 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post discharge from hospital

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is studying how well different combinations of drugs work in restoring the blood flow in the arteries of the brain after a subarachnoid hemorrhage. The different combinations of drugs will be compared to each other and to the standard treatment to see which works best.

Who is the study for?

This trial is for adults aged 18-80 who've had a ruptured aneurysm treated and then developed cerebral vasospasm within 3-21 days post-surgery. It's not for those unable to consent, pregnant women, outside the age range, with severe subarachnoid hemorrhage (Hunt Hess Grade 5), or have already received treatment in all arterial territories.

What is being tested?

The study aims to find the best intra-arterial drug combo for restoring blood vessel width after cerebral vasospasm due to aneurysmal subarachnoid hemorrhage. It compares Nicardipine, Verapamil, and their combination with Nitroglycerin on artery opening and patient recovery at 90 days.

What are the potential side effects?

Possible side effects of Nicardipine and Verapamil include low blood pressure, headache, dizziness, nausea; adding Nitroglycerin might increase these risks. All drugs are FDA approved and used as standard care.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18-80 years old and had a brain aneurysm rupture, with complications within 3-21 days after surgery.

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I have symptoms of narrowed blood vessels in my brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received drug treatment through an artery in all 3 arterial territories.

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I am younger than 18 or older than 80.

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My condition is a severe brain hemorrhage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post discharge from hospital

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post discharge from hospital

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post discharge from hospital for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post infusion improvement ratio(PIIR)

Secondary study objectives

To grade clinical outcome using Modified Rankin score

Other study objectives

Intra-cranial pressure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups

Active Control

Group I: VerapamilActive Control1 Intervention

Group 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty

Group II: NicardipineActive Control1 Intervention

Group 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty

Group III: Nicardipine + Verapamil + NitroglycerinActive Control1 Intervention

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

0 / 5Eligibility criteria met