Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Newcastle-upon-Tyne Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
North East Ambulance Service NHS Trust
Northumbria Healthcare NHS Foundation Trust
Information provided by:
Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01066572
First received: February 9, 2010
Last updated: December 13, 2010
Last verified: December 2010
  Purpose

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


Condition Intervention Phase
Stroke
Drug: Lisinopril
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paramedic Initiated Lisinopril For Acute Stroke Treatment: a Pilot Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Primary Outcome Measures:
  • Number of participants enrolled per month [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The primary outcome measure is the number of participants enrolled in the study per month.


Secondary Outcome Measures:
  • Proportion fulfilling eligibility criteria [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The proportion of suspected acute stroke patients admitted to research sites during the trial duration who fulfilled the study eligibility criteria

  • Proportion attended by research trained paramedic [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The proportion of study eligible patients attended by a research trained paramedic

  • Proportion enrolled by research trained paramedic [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The proportion of study eligible patients enrolled into the study by a researc trained paramedic

  • Proportion approached but not enrolled [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The proportion of study eligible patients approached about the research study but not enrolled, and the reasons for non-enrolment, where possible.

  • Additional time spent on scene [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The additional time spent on scene by research trained paramedics to enrol a participant into the study.

  • Paramedic compliance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Paramedic compliance with study data collection.

  • Hospital staff compliance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Hospital staff compliance with study medication administration and data collection.

  • Proportion completing study medication [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The proportion of study participants with confirmed stroke who complete seven days of study medication.

  • Clinical outcome measures [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Clinical outcome measures are blood pressure, neurological score, dependency score and renal function.

  • Adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Adverse events in control and intervention groups during the study.


Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lisinopril Drug: Lisinopril
5-10 mg Lisinopril per day for seven days, depending on blood pressure.
Placebo Comparator: Placebo Drug: Placebo
Matched placebo; identical tablets to Lisinopril.

Detailed Description:

High blood pressure immediately following stroke is common and related to poorer stroke functional outcome and death. Although treatment of high blood pressure is well established for thre prevention of stroke, it is unclear if high blood pressure observed immediately after stroke should be lowered.

Several previous clinical trials have lowered blood pressure in acute stroke but this has not resulted in improved stroke outcome. One reason for this may be because treatment was started too late after stroke occurred. There is rapid progression of brain injury following stroke and any stroke treatment may need to be started very early to have a beneficial effect. Previous trials started blood pressure lowering after patients arrived at hospital and this was usually a significant time after stroke occurred.

The earliest time after stroke that blood pressure treatment could be started is during contact with the emergency medical services (paramedics). This research study is a pilot double blind randomised controlled trial of paramedic initiated blood pressure treatment for patients with high blood pressure immediately after stroke.

Patients with high blood pressure and suspected acute stroke will be identified and offered the opportunity to participate in the study by research trained paramedics from the North East Ambulance Service NHS Trust. Patients who agree to participate in the study will receive either lisinopril (a common blood pressure lowering medication) or 'dummy' (placebo) treatments for seven days. The first dose of medication will be given by the paramedic in the ambulance. Subsequent tablets will be given in hospital. The effects of treatment will be monitored by measuring blood pressure, neurological outcome and adverse events.

All aspects of study feasibility including recruitment rates and compliance with data collection will be recorded. The study will run for one year and recruit 60 patients.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion criteria:

  • 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
  • Significant head trauma or brain surgery in the last 3 months
  • Known renal failure
  • Known liver failure (or currently jaundiced)
  • Uncontrolled heart failure (breathlessness at rest)
  • Receiving palliative care for known malignancy
  • Currently enrolled in a clinical trial assessing a study drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066572

Contacts
Contact: Gary Ford, Prof +44 (0)191 222 7744 g.a.ford@ncl.ac.uk
Contact: Gillian Watson, BSc (Hons) +44 (0)191 222 8813 gillian.watson@ncl.ac.uk

Locations
United Kingdom
Wansbeck General Hospital Recruiting
Ashington, Northumberland, United Kingdom, NE63 9JJ
Principal Investigator: Christopher Price         
Royal Victoria Infirmary, Queen Victoria Road Recruiting
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
Principal Investigator: Anand Dixit         
North East Ambulance Service NHS Trust Recruiting
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE15 8NY
Principal Investigator: Christopher Price         
North Tyneside General Hospital Recruiting
North Shields, Tyne and Wear, United Kingdom, NE29 8NH
Principal Investigator: Christopher Price         
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
North East Ambulance Service NHS Trust
Northumbria Healthcare NHS Foundation Trust
Investigators
Principal Investigator: 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 Trust
  More Information

No publications provided by Newcastle-upon-Tyne Hospitals NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ms Amanda Tortice, The Newcastle upon Tyne Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01066572     History of Changes
Other Study ID Numbers: RP-PG-0606-1241
Study First Received: February 9, 2010
Last Updated: December 13, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014