Trial Outcomes & Findings for Field Administration of Stroke Therapy-Blood Pressure Lowering (NCT NCT01811693)

NCT ID: NCT01811693

Last Updated: 2020-10-29

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 4 participants
• Primary outcome timeframe: Baseline, 15 minutes after treatment
• Results posted on: 2020-10-29

Participant Flow

Participant milestones

Measure	Dose Tier 1 Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal Glycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal	Dose Tier 2 Glycerly Trinitrate (Nitroglycerine) 10mg/24hour (0.4mg/hour) transdermal Glycerly Trinitrate: 10mg/24hour (0.4mg/hour) transdermal	Dose Tier 3 Glycerly Trinitrate (GTN, Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal plus a single metered dose 0.4mg of sublingual GTN Glycerly Trinitrate: 10mg/24hour (0.4mg/hour) transdermal Glycerly Trinitrate: 0.4 mg sublingual single metered spray
Overall Study STARTED	4	0	0
Overall Study COMPLETED	4	0	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Field Administration of Stroke Therapy-Blood Pressure Lowering

Baseline characteristics by cohort

Measure	Dose Tier 1 n=4 Participants Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal Glycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal	Dose Tier 2 Glycerly Trinitrate (Nitroglycerine) 10mg/24hour (0.4mg/hour) transdermal Glycerly Trinitrate: 10mg/24hour (0.4mg/hour) transdermal	Dose Tier 3 Glycerly Trinitrate (GTN, Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal plus a single metered dose 0.4mg of sublingual GTN Glycerly Trinitrate: 10mg/24hour (0.4mg/hour) transdermal Glycerly Trinitrate: 0.4 mg sublingual single metered spray	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Dose Tier 1 n=4 Participants Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal Glycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal
Participants With Systolic Blood Pressure Change of 8mmHg or More	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days after enrollment

Outcome measures

Measure	Dose Tier 1 n=4 Participants Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal Glycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal
Participants Experiencing Serious Adverse Events No SAE	2 Participants
Participants Experiencing Serious Adverse Events SAE	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Dose Tier 1 n=4 Participants Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal Glycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal
Participants Exhibiting Neurological Deterioration as Indicated by a Two-point or Greater Worsening in the Glasgow Coma Scale	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours after enrollment

Outcome measures

Measure	Dose Tier 1 n=4 Participants Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal Glycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal
Participants With Systolic Blood Pressure Less Than 120 mm/Hg	0 Participants

Adverse Events

Dose Tier 1

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dose Tier 1 n=4 participants at risk Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal Glycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal
Vascular disorders Death	50.0% 2/4 • Number of events 2 • 90 days after enrollment

Other adverse events

Adverse event data not reported

Additional Information

Nerses Sanossian, MD

Keck School of Medicine of USC

Phone: 323-442-7793

Email: nsanossi@usc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place