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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post discharge from hospital
Awards & highlights

iVAST Trial 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.Check my eligibility
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.See study design
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.

iVAST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18-80 years old and had a brain aneurysm rupture, with complications within 3-21 days after surgery.
Select...
I have symptoms of narrowed blood vessels in my brain.

iVAST Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post infusion improvement ratio(PIIR)
Secondary outcome measures
To grade clinical outcome using Modified Rankin score
Other outcome measures
Intra-cranial pressure

iVAST 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

Find a Location

Who is running the clinical trial?

WeatherheadUNKNOWN
Peng Roc ChenLead Sponsor
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,630 Total Patients Enrolled

Media Library

Nicardipine (Calcium Channel Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT01996436 — Phase 4
Cerebral Vasospasm Research Study Groups: Verapamil, Nicardipine, Nicardipine + Verapamil + Nitroglycerin
Cerebral Vasospasm Clinical Trial 2023: Nicardipine Highlights & Side Effects. Trial Name: NCT01996436 — Phase 4
Nicardipine (Calcium Channel Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01996436 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what capacity is this clinical trial reaching its enrollment quota?

"Affirmative, the clinical trial is actively searching for patients. It was posted on August 29th 2016 and last updated on December 15 2021; it requires 330 participants from 3 medical centres."

Answered by AI

Are persons of a younger age bracket allowed to partake in this clinical research?

"Applicants who meet the criteria of this medical study must be between 18 and 80 years old. For those below 18, there are 2 clinical trials available; for senior citizens over 65, 25 studies have been launched."

Answered by AI

Would I be eligible for enrollment in this experiment?

"This research project is engaging 330 participants, aged between 18 and 80, who suffer from cerebral vasospasm. The prerequisite qualifications for involvement in the study include being an adult patient of age 18-80 years old with a ruptured aneurysm(s) experiencing symptomatic vasospasm (clinical or TCD), as well as having developed said condition within 3 to 21 days post operatively."

Answered by AI

Are there any previous investigations that have explored Nicardipine use?

"Nicardipine was initially studied in 2009 at Seoul National University Bundang Hospital. Since then, 157 clinical trials have been conducted and 15 are currently underway - the majority of them being based out of Manhasset, New york."

Answered by AI

For what medical concerns is Nicardipine typically prescribed?

"Nicardipine is a common medication used to manage the symptoms of angina pectoris. This drug can also provide relief for those suffering from atrial fibrillation, flutter and unstable angina pectoris."

Answered by AI

Are there opportunities for individuals to be part of this experiment?

"This clinical trial is actively on the lookout for participants. It was first posted in August of 2016 and most recently revised at the end of December 2021, according to information available from clinicaltrials.gov."

Answered by AI

Has Nicardipine been granted regulatory authorization by the FDA?

"Nicardipine is categorized as safe by our team at Power, since it has reached Phase 4 of clinical trials and therefore been given approval. This safety rating was assigned a score of 3."

Answered by AI
Recent research and studies
~4 spots leftby Jun 2024