Intracerebral HemorrhagePhase 2FAST-BPNCT01811693
Field Administration of Stroke Therapy-Blood Pressure Lowering
A Phase 2 study testing Glycerly Trinitrate in people with Intracerebral Hemorrhage and Ischemic Stroke, run by University of California, Los Angeles at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage, Ischemic Stroke
- What is being tested?
- Glycerly Trinitrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to 9 Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Los Alamitos Medical Center
Los Alamitos, California, 90720
FAST-MAG Clinical Trial Coordinating Center
Los Angeles, California, 90024
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- Conditions
- Intracerebral Hemorrhage, Ischemic Stroke
- Being tested
- Glycerly Trinitrate
- Keywords
- Stroke, Intracerebral Hemorrhage, Prehospital, Antihypertensive
- Medical subject headings
- Cerebral Hemorrhage, Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycerly TrinitrateDrug
Also called Nitroglycerine, GTN
5mg/24hour (0.2mg/hour) transdermal
Glycerly TrinitrateDrug
Also called Nitroglycerine, GTN
10mg/24hour (0.4mg/hour) transdermal
Glycerly TrinitrateDrug
Also called Nitroglycerine, GTN
0.4 mg sublingual single metered spray
| Study group | Role | What they receive |
|---|---|---|
| Dose Tier 1 | Experimental | Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal Receives: Drug: Glycerly Trinitrate |
| Dose Tier 2 | Experimental | Glycerly Trinitrate (Nitroglycerine) 10mg/24hour (0.4mg/hour) transdermal Receives: 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 Receives: Drug: Glycerly Trinitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 15 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startApr 2013
- Primary completion10 Sep 2013
- Study completion9 Dec 2013
Why it stopped: The funding period for the study has ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey L. Saver, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811693
- Sponsor's protocol ID
- FBP001
- Acronym
- FAST-BP
- Status last verified
- Oct 2020
- First submitted
- 6 Mar 2013
- Last updated
- 29 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Field Administration of Stroke Therapy-Blood Pressure Lowering Pilot Trial
- ClinicalTrials.gov ID
- NCT01811693
- Acronym / sponsor ID
- FAST-BP / FBP001
- Conditions
- Intracerebral Hemorrhage, Ischemic Stroke
- Keywords
- Stroke, Intracerebral Hemorrhage, Prehospital, Antihypertensive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The funding period for the study has ended.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- 10 Sep 2013 (actual)
- Study completion
- 9 Dec 2013 (actual)
- First posted
- 14 Mar 2013 (estimated)
- Results
- Posted 29 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Tier 1 | Experimental | Drug: Glycerly TrinitrateGlycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal |
| Dose Tier 2 | Experimental | Drug: Glycerly TrinitrateGlycerly Trinitrate (Nitroglycerine) 10mg/24hour (0.4mg/hour) transdermal |
| Dose Tier 3 | Experimental | Drug: Glycerly TrinitrateGlycerly Trinitrate (GTN, Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal plus a single metered dose 0.4mg of sublingual GTN |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycerly TrinitrateAlso: Nitroglycerine, GTN5mg/24hour (0.2mg/hour) transdermal | Drug | Dose Tier 1 |
| Glycerly TrinitrateAlso: Nitroglycerine, GTN10mg/24hour (0.4mg/hour) transdermal | Drug | Dose Tier 2, Dose Tier 3 |
| Glycerly TrinitrateAlso: Nitroglycerine, GTN0.4 mg sublingual single metered spray | Drug | Dose Tier 3 |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glycerly Trinitrate in people with Intracerebral Hemorrhage and Ischemic Stroke, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Systolic Blood Pressure Change of 8mmHg or More (time frame: Baseline, 15 minutes after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.