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

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ClinicalTrials.gov Identifier: NCT01811693
Recruitment Status : Unknown
Verified June 2015 by Nerses Sanossian, University of Southern California.
Recruitment status was:  Recruiting
First Posted : March 14, 2013
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
Nerses Sanossian, University of Southern California

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.

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Ischemic Stroke Drug: Glycerly Trinitrate Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Field Administration of Stroke Therapy-Blood Pressure Lowering Pilot Trial
Study Start Date : April 2013
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine


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

Experimental: Dose Tier 2
Glycerly Trinitrate (Nitroglycerine) 10mg/24hour (0.4mg/hour) transdermal
Drug: Glycerly Trinitrate
10mg/24hour (0.4mg/hour) transdermal
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
10mg/24hour (0.4mg/hour) transdermal
Other Names:
  • Nitroglycerine
  • GTN

Drug: Glycerly Trinitrate
0.4 mg sublingual single metered spray
Other Names:
  • Nitroglycerine
  • GTN




Primary Outcome Measures :
  1. Mean blood pressure change [ Time Frame: 15 minutes after treatment ]
    The mean change in blood pressure will be measured in the Emergency Department approximately 15 minutes after application of the treatment


Other Outcome Measures:
  1. Serious adverse events [ Time Frame: 90 days after enrollment ]
  2. Neurological Deterioration [ Time Frame: One hour after enrollment ]
    A two-point or greater worsening in the Glasgow Coma Scale

  3. Systolic Blood Pressure less than 120 mm/Hg [ Time Frame: 24 hours after enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811693


Contacts
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Contact: Nerses Sanossian, MD 3234093440 nsanossi@usc.edu

Locations
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United States, California
Los Alamitos Medical Center Recruiting
Los Alamitos, California, United States, 90720
Contact: Laura Cross    310-279-3607    lcross@mednet.ucla.edu   
Principal Investigator: Jeremy Kroes, MD         
FAST-MAG Clinical Trial Coordinating Center Recruiting
Los Angeles, California, United States, 90024
Contact: Maria Trejo    310-794-6160    mtrejo@mednet.ucla.edu   
Principal Investigator: Nerses Sanossian, MD         
Principal Investigator: Jeffrey L Saver, MD         
Principal Investigator: Sidney Starkman, MD         
Sponsors and Collaborators
University of California, Los Angeles

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Responsible Party: Nerses Sanossian, Co-Principal Investigator, University of Southern California
ClinicalTrials.gov Identifier: NCT01811693    
Other Study ID Numbers: FBP001
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015
Keywords provided by Nerses Sanossian, University of Southern California:
Stroke
Intracerebral Hemorrhage
Prehospital
Antihypertensive
Additional relevant MeSH terms:
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Stroke
Cerebral Hemorrhage
Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages
Nitroglycerin
Vasodilator Agents