Paramedic Initiated Lisinopril For Acute Stroke Treatment

NCT01066572 | Completed Phase 1

• 1 other identifier: RP-PG-0606-1241
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 4

Brief Summary

This study aims to investigate the use of lisinopril to lower blood pressure in stroke patients, pre-hospital, by research-trained paramedics.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Number of participants enrolled per month

  The primary outcome measure is the number of participants enrolled in the study per month.

  1 year

Secondary Outcomes (10)

• Proportion fulfilling eligibility criteria

  1 year

• Proportion attended by research trained paramedic

  1 year

• Proportion enrolled by research trained paramedic

  1 year

• Proportion approached but not enrolled

  1 year

• Additional time spent on scene

  1 year

Study Arms (2)

Lisinopril

EXPERIMENTAL

Experimental

Drug: Lisinopril

Placebo

PLACEBO COMPARATOR

Placebo Comparator

Drug: Placebo

Interventions

Lisinopril DRUG

5-10 mg Lisinopril per day for seven days, depending on blood pressure.

Also known as: ACE inhibitor

Lisinopril

Placebo DRUG

Matched placebo; identical tablets to Lisinopril.

Also known as: Dummy drug

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 40 years old
• New unilateral arm weakness thought to be due to acute stroke within 3 hours of symptom onset
• Hypertension as defined by systolic BP \>160mm Hg on two consecutive seated or lying readings taken 5 - 10 minutes apart
• Conscious (eyes open spontaneously ie "A" on Alert, Voice, Pain, Unresponsive (AVPU) scale)
• Patient being transported to a PIL-FAST trial site (i.e. Royal Victoria Infirmary, North Tyneside General Hospital and Wansbeck General Hospital)
• Verbal consent obtained from participant or next of kin

You may not qualify if:

• Age \< 40 years
• Females who are pregnant, lactating or at risk of pregnancy (i.e. who are not surgically sterile or at least 1 year post last menstrual period). Females \< 56 years of age consented by a relative will be excluded as menstrual history may be unknown.
• Any presentation of suspected stroke without unilateral arm weakness
• Cannot establish that stroke onset time (i.e. when patient was last seen well without symptoms) was within the last 3 hours
• Systolic BP \< 160mm Hg
• Reduced level of consciousness (below "A" on AVPU scale)
• Patient not being transported to PIL-FAST trial site
• Absence of participant or next of kin consent
• Known to be taking ACE-inhibitor or Angiotensin II Receptor Blocker medication already
• Known sensitivity to lisinopril or other ACE-inhibitor medication
• Pulse \> 120 beats per minute
• Seizure activity in this illness episode (witnessed or history)
• Hypoglycaemia (blood glucose \< 3.5 mmols/l)
• Cannot walk independently prior to stroke (walking stick / frame is allowed)
• Obvious understanding or memory problems when next of kin is absent

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead
• North East Ambulance Service NHS Foundation Trust: collaborator
• Northumbria Healthcare NHS Foundation Trust: collaborator

Study Sites (4)

Wansbeck General Hospital

Ashington, Northumberland, NE63 9JJ, United Kingdom

Location

Royal Victoria Infirmary, Queen Victoria Road

Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

Location

North East Ambulance Service NHS Trust

Newcastle upon Tyne, Tyne and Wear, NE15 8NY, United Kingdom

Location

North Tyneside General Hospital

North Shields, Tyne and Wear, NE29 8NH, United Kingdom

Location

Related Publications (2)

• Shaw L, Price C, McLure S, Howel D, McColl E, Younger P, Ford GA. Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): results from the pilot randomised controlled trial. Emerg Med J. 2014 Dec;31(12):994-9. doi: 10.1136/emermed-2013-202536. Epub 2013 Sep 27.

  PMID: 24078198 DERIVED

• Shaw L, Price C, McLure S, Howel D, McColl E, Ford GA. Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): study protocol for a pilot randomised controlled trial. Trials. 2011 Jun 15;12:152. doi: 10.1186/1745-6215-12-152.

  PMID: 21676221 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Lisinopril; Angiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Christopher Price

  Northumbria Healthcare NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Anand Dixit

  Newcastle-upon-Tyne Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

• Ann Fox

  North East Ambulance Service NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 10, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 30, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)