Field Administration of Stroke Therapy-Blood Pressure Lowering

NCT01811693 | Terminated Phase 2 Results DMC

• 1 other identifier: FBP001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open, pilot, dose-escalation study of glyceryl trinitrate (GTN, Nitroglycerin) administered by paramedics in the field within 2 hours of symptom onset to 45 severely hypertensive stroke patients. The primary objective of the study is to evaluate the feasibility, safety, and physiologic efficacy of field-initiated glyceryl trinitrate in achieving modest reduction of blood pressure. Patients with acute stroke will be identified in the field by paramedics who have received training in basic and advanced cardiac life support, stroke recognition, and specific procedures relevant to the proposed study. Physician-investigators will obtain informed consent for each subject for study entry after cellular phone contact with paramedics. Paramedics will initiate antihypertensive treatment by applying transdermal GTN patch in the first two dose-tiers, and administering a single sublingual GTN metered spray followed by application of the transdermal system in the last dose tier. The sites involved in the study will be emergency medical services rescue ambulances and 8 receiving Stroke Center hospitals in Orange County, California, USA.

Conditions

Intracerebral Hemorrhage; Ischemic Stroke

Keywords

Stroke; Intracerebral Hemorrhage; Prehospital; Antihypertensive

Outcome Measures

Primary Outcomes (1)

• Participants With Systolic Blood Pressure Change of 8mmHg or More

  The mean change in blood pressure was measured in the Emergency Department approximately 15 minutes after application of the treatment

  Baseline, 15 minutes after treatment

Other Outcomes (3)

• Participants Experiencing Serious Adverse Events

  90 days after enrollment

• Participants Exhibiting Neurological Deterioration as Indicated by a Two-point or Greater Worsening in the Glasgow Coma Scale

  Baseline, One hour after enrollment

• Participants With Systolic Blood Pressure Less Than 120 mm/Hg

  24 hours after enrollment

Study Arms (3)

Dose Tier 1

EXPERIMENTAL

Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal

Drug: Glycerly Trinitrate

Dose Tier 2

EXPERIMENTAL

Glycerly Trinitrate (Nitroglycerine) 10mg/24hour (0.4mg/hour) transdermal

Drug: Glycerly Trinitrate

Dose Tier 3

EXPERIMENTAL

Glycerly Trinitrate (GTN, Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal plus a single metered dose 0.4mg of sublingual GTN

Drug: Glycerly Trinitrate

Interventions

Glycerly Trinitrate DRUG

5mg/24hour (0.2mg/hour) transdermal

Also known as: Nitroglycerine, GTN

Dose Tier 1

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected stroke identified with Los Angeles Prehospital Stroke Screen
• Age 40-80, inclusive
• Last known well time within 2 hours of treatment initiation
• Deficit present for \> 15 minutes
• Systolic blood pressure ≥180

You may not qualify if:

• Coma
• Rapidly improving neurologic deficit
• Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
• Severe respiratory distress (O2 sat \< 90% or respiratory rate \< 12 or \> 24)
• Major head trauma in the last 24 hours
• Recent stroke within prior 30 days
• Use of erectile dysfunction therapies in the previous 12 hours
• Use of type V phosphodiesterase inhibitors
• Patient unable to give informed consent and no available legally authorized representative (LAR) to provide informed consent

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (2)

Los Alamitos Medical Center

Los Alamitos, California, 90720, United States

Location

FAST-MAG Clinical Trial Coordinating Center

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage; Ischemic Stroke; Stroke

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Results Point of Contact

• Title: Nerses Sanossian, MD
• Organization: Keck School of Medicine of USC

nsanossi@usc.edu

323-442-7793

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 14, 2013
• Study Start: April 1, 2013
• Primary Completion: September 10, 2013
• Study Completion: December 9, 2013
• Last Updated: October 29, 2020
• Results First Posted: October 29, 2020

Record last verified: 2020-10

Locations

US (2)