The Intra-arterial Vasospasm Trial

NCT01996436 | Terminated Phase 4 Results DMC

• 1 other identifier: IVT_201310 (HSC-MS-13-0586)
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 5

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.

Conditions

Cerebral Vasospasm

Keywords

cerebral vasospasm; aneurysmal subarachnoid hemorrhage; intra arterial drug treatment for cerebral vasospasm; nicardipine milrinone nitroglycerin verapamil

Outcome Measures

Primary Outcomes (1)

• Post Infusion Improvement Ratio (PIIR)

  Post infusion improvement ratio (PIIR) = ((B - A) / A) \*100 A = pre-infusion blood vessel diameter B = post infusion blood vessel diameter

  pre pharmacological angioplasty blood vessel diameter - 0 min, post pharmacological angioplasty blood vessel diameter- 10 min after infusion

Secondary Outcomes (1)

• Disability or Dependence in Daily Activities as Assessed by the Modified Rankin Score

  3 months post discharge from hospital

Other Outcomes (1)

• Intra-cranial Pressure

  1 day prior to procedure & 1 day after the procedure

Study Arms (3)

Nicardipine

ACTIVE COMPARATOR

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

Drug: Nicardipine

Verapamil

ACTIVE COMPARATOR

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

Drug: Verapamil

Nicardipine + Verapamil + Nitroglycerin

ACTIVE COMPARATOR

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

Drug: Nicardipine + Verapamil + Nitroglycerin

Interventions

Nicardipine DRUG

Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm

Also known as: Cardene

Nicardipine

Verapamil DRUG

Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm

Verapamil

Nicardipine + Verapamil + Nitroglycerin DRUG

Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm

Nicardipine + Verapamil + Nitroglycerin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peng Roc Chen, MD: lead
• Yale University: collaborator
• Thomas Jefferson University: collaborator
• University of Illinois at Chicago: collaborator
• Wake Forest University Health Sciences: collaborator
• Temple University: collaborator
• Geisinger Clinic: collaborator
• Northwell Health: collaborator
• University of Michigan: collaborator
• Lenox Hill Hospital: collaborator
• Weatherhead Foundation: collaborator
• University of California, Irvine: collaborator

Study Sites (5)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

University of Texas Medical School at Houston

Houston, Texas, 77030, United States

Location

Related Publications (9)

• Dorsch NW, King MT. A review of cerebral vasospasm in aneurysmal subarachnoid haemorrhage Part I: Incidence and effects. J Clin Neurosci. 1994 Jan;1(1):19-26. doi: 10.1016/0967-5868(94)90005-1.

  PMID: 18638721 BACKGROUND

• Treggiari MM, Walder B, Suter PM, Romand JA. Systematic review of the prevention of delayed ischemic neurological deficits with hypertension, hypervolemia, and hemodilution therapy following subarachnoid hemorrhage. J Neurosurg. 2003 May;98(5):978-84. doi: 10.3171/jns.2003.98.5.0978.

  PMID: 12744357 BACKGROUND

• Biller J, Godersky JC, Adams HP Jr. Management of aneurysmal subarachnoid hemorrhage. Stroke. 1988 Oct;19(10):1300-5. doi: 10.1161/01.str.19.10.1300. No abstract available.

  PMID: 3176090 BACKGROUND

• Kassell NF, Sasaki T, Colohan AR, Nazar G. Cerebral vasospasm following aneurysmal subarachnoid hemorrhage. Stroke. 1985 Jul-Aug;16(4):562-72. doi: 10.1161/01.str.16.4.562.

  PMID: 3895589 BACKGROUND

• Keuskamp J, Murali R, Chao KH. High-dose intraarterial verapamil in the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. J Neurosurg. 2008 Mar;108(3):458-63. doi: 10.3171/JNS/2008/108/3/0458.

  PMID: 18312091 BACKGROUND

• Linfante I, Delgado-Mederos R, Andreone V, Gounis M, Hendricks L, Wakhloo AK. Angiographic and hemodynamic effect of high concentration of intra-arterial nicardipine in cerebral vasospasm. Neurosurgery. 2008 Dec;63(6):1080-6; discussion 1086-7. doi: 10.1227/01.NEU.0000327698.66596.35.

  PMID: 19057319 BACKGROUND

• Badjatia N, Topcuoglu MA, Pryor JC, Rabinov JD, Ogilvy CS, Carter BS, Rordorf GA. Preliminary experience with intra-arterial nicardipine as a treatment for cerebral vasospasm. AJNR Am J Neuroradiol. 2004 May;25(5):819-26.

  PMID: 15140728 BACKGROUND

• Pierot L, Aggour M, Moret J. Vasospasm after aneurysmal subarachnoid hemorrhage: recent advances in endovascular management. Curr Opin Crit Care. 2010 Apr;16(2):110-6. doi: 10.1097/MCC.0b013e3283372ef2.

  PMID: 20098322 BACKGROUND

• Fraticelli AT, Cholley BP, Losser MR, Saint Maurice JP, Payen D. Milrinone for the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Stroke. 2008 Mar;39(3):893-8. doi: 10.1161/STROKEAHA.107.492447. Epub 2008 Jan 31.

  PMID: 18239182 BACKGROUND

MeSH Terms

Conditions

Vasospasm, Intracranial; Subarachnoid Hemorrhage

Interventions

Nicardipine; Verapamil; Nitroglycerin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Nitro Compounds

Results Point of Contact

• Title: Peng Roc Chen, MD
• Organization: The University of Texas Health Science Center at Houston

Peng.R.Chen@uth.tmc.edu

713-486-8016

Study Officials

• Peng R Chen, MD

  University of Texas Medical School at Houston

  PRINCIPAL INVESTIGATOR

• Ketan R Bulsara, MD, MBA

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in Neurosurgery

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 27, 2013
• Study Start: August 29, 2016
• Primary Completion: April 29, 2024
• Study Completion: August 12, 2024
• Last Updated: May 11, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)