Field Administration of Stroke Therapy-Blood Pressure Lowering (FAST-BP)

October 5, 2020 updated by: Jeffrey L. Saver, University of California, Los Angeles

The Field Administration of Stroke Therapy-Blood Pressure Lowering Pilot Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The central aim of this phase 2a study is to identify a regimen of paramedic initiated glyceryl trinitrate antihypertensive therapy in acute stroke patients that is safe, is technically effective in modestly lowering blood pressure, and is optimal to advance to a pivotal trial. The study design is an open-label dose escalation study with three dose tiers,. It is anticipated that the trial will identify the most promising prehospital GTN regimen to advance to a pivotal, placebo-controlled, phase 3 trial.

Primary Hypothesis: Prehospital glyceryl trinitrate treatment reduces severely hypertensive blood pressure elevation by ED arrival.

The primary study endpoint to test this hypothesis will be the mean change in SBP from pre-treatment to ED arrival.

Secondary Hypotheses:

  1. Prehospital glyceryl trinitrate treatment reduces severely hypertensive blood pressure elevation at early post-arrival timepoints and increases the proportion of patients with target blood pressure at ED arrival and early post-arrival timepoints.

    The secondary study endpoints analyzed to test these hypotheses will be: 1) mean change in SBP from pre-treatment to 30 minutes after ED arrival and 60 minutes after ED arrival; and 2) the proportion of patients with SBP < 180 mm Hg at ED arrival, 30, and 60 minutes after arrival.

  2. Prehospital initiation of glyceryl trinitrate in the first 2 hours for severely hypertensive patients with stroke is feasible and safe.

Safety of GTN in the first 2 hours for severely hypertensive stroke patients will be assessed by analysis of serious adverse events, neurologic change, and mortality. We hypothesize that initiation of treatment of the patients in the field will be associated with a favorable side effect profile and without severe blood pressure lowering to les than 120 mm Hg systolic.

Successful completion of the study will demonstrate feasibility to recruit hypertensive stroke participants and initiate GTN therapy in the field by paramedics.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Alamitos, California, United States, 90720
        • Los Alamitos Medical Center
      • Los Angeles, California, United States, 90024
        • FAST-MAG Clinical Trial Coordinating Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Tier 1
Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal
Drug: Glycerly Trinitrate
5mg/24hour (0.2mg/hour) transdermal
Other Names:
  • Nitroglycerine
  • GTN
Drug: Glycerly Trinitrate
10mg/24hour (0.4mg/hour) transdermal
Other Names:
  • Nitroglycerine
  • GTN
Drug: Glycerly Trinitrate
0.4 mg sublingual single metered spray
Other Names:
  • Nitroglycerine
  • GTN
Experimental: Dose Tier 2
Glycerly Trinitrate (Nitroglycerine) 10mg/24hour (0.4mg/hour) transdermal
Drug: Glycerly Trinitrate
5mg/24hour (0.2mg/hour) transdermal
Other Names:
  • Nitroglycerine
  • GTN
Drug: Glycerly Trinitrate
10mg/24hour (0.4mg/hour) transdermal
Other Names:
  • Nitroglycerine
  • GTN
Drug: Glycerly Trinitrate
0.4 mg sublingual single metered spray
Other Names:
  • Nitroglycerine
  • GTN
Experimental: Dose Tier 3
Glycerly Trinitrate (GTN, Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal plus a single metered dose 0.4mg of sublingual GTN
Drug: Glycerly Trinitrate
5mg/24hour (0.2mg/hour) transdermal
Other Names:
  • Nitroglycerine
  • GTN
Drug: Glycerly Trinitrate
10mg/24hour (0.4mg/hour) transdermal
Other Names:
  • Nitroglycerine
  • GTN
Drug: Glycerly Trinitrate
0.4 mg sublingual single metered spray
Other Names:
  • Nitroglycerine
  • GTN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants With Systolic Blood Pressure Change of 8mmHg or More
Time Frame: Baseline, 15 minutes after treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants Experiencing Serious Adverse Events
Time Frame: 90 days after enrollment
90 days after enrollment
Participants Exhibiting Neurological Deterioration as Indicated by a Two-point or Greater Worsening in the Glasgow Coma Scale
Time Frame: Baseline, One hour after enrollment
The Glasgow Coma Scale (GCS) score measures level of consciousness in eye, motor, and verbal components. At least one point is given in each category. The scale ranges from 3 to 15, with 3 indicating deep unconsciousness and 15 indicating consciousness is not impaired.
Baseline, One hour after enrollment
Participants With Systolic Blood Pressure Less Than 120 mm/Hg
Time Frame: 24 hours after enrollment
24 hours after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

September 10, 2013

Study Completion (Actual)

December 9, 2013

Study Registration Dates

First Submitted

March 6, 2013

First Submitted That Met QC Criteria

March 12, 2013

First Posted (Estimate)

March 14, 2013

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FBP001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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