The Field Administration of Stroke Therapy-Blood Pressure Lowering Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Participants With Systolic Blood Pressure Change of 8mmHg or More
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Dose Tier 1
Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal
干预措施: Glycerly Trinitrate (Drug)
Dose Tier 2
Glycerly Trinitrate (Nitroglycerine) 10mg/24hour (0.4mg/hour) transdermal
干预措施: Glycerly Trinitrate (Drug)
Dose Tier 3
Glycerly Trinitrate (GTN, Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal plus a single metered dose 0.4mg of sublingual GTN
干预措施: Glycerly Trinitrate (Drug)
结局指标
主要结局
Participants With Systolic Blood Pressure Change of 8mmHg or More
时间窗: 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
次要结局
未报告次要终点
研究者
Jeffrey L. Saver
Principal Investigator
University of California, Los Angeles