<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03782857</url>
  </required_header>
  <id_info>
    <org_study_id>2012-41-0429</org_study_id>
    <nct_id>NCT03782857</nct_id>
  </id_info>
  <brief_title>Prevention After Stroke - a Nurse-led Physician-supervised Model</brief_title>
  <official_title>Prevention After Stroke - a Nurse-led Physician-Supervised Model. A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nete Hornnes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Herlev Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study evaluates the effect of early follow up in a preventive clinic with stepwise&#xD;
      treatment of high blood pressure and lowering blood cholesterol. Half the participants were&#xD;
      randomized to the preventive clinic group and the other half to control group with the usual&#xD;
      treatment: one visit to the outpatient clinic three months after discharge with a diagnosis&#xD;
      of stroke or transient ischemic attack (TIA)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypertension is the most important modifiable risk factor for recurrent stroke. Several&#xD;
      studies have shown that less than 40% of stroke survivors are treated to target one year&#xD;
      after stroke The investigator performed a feasibility study to test a model of treating this&#xD;
      important risk factor in a hospital setting The investigator used a stepwise escalation of&#xD;
      treatment of both blood pressure and blood cholesterol to individual targets according to&#xD;
      patients' diagnosis of stroke, comorbidity and age&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2012</start_date>
  <completion_date type="Actual">December 17, 2013</completion_date>
  <primary_completion_date type="Actual">December 17, 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants were randomized 1:1 to intervention or control group</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood pressure treated to target</measure>
    <time_frame>At follow up 10 months after inclusion in the study</time_frame>
    <description>The investigator used individual targets of blood pressure: In case of hemorrhagic stroke: BP&lt;130/80 mm Hg, in case of ischemic heart disease: BP target according to stroke diagnosis, but no lower than 130/80 mm Hg, in case of diabetes or chronic kidney disease: BP&lt;130/80 mm Hg, age&gt;80 years: &lt;150/90 mm Hg, others: &lt;140/90 mm Hg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in blood pressure</measure>
    <time_frame>At follow up 10 months after inclusion in the study</time_frame>
    <description>Difference between blood pressure at inclusion in the study and blood pressure measured at final follow up</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Reduction in LDL-cholesterol</measure>
    <time_frame>At follow up 10 months after inclusion in the study</time_frame>
    <description>Difference between LDL-cholesterol at inclusion in the study and LDL-cholesterol measured at final follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>LDL-cholesterol treated to target</measure>
    <time_frame>At follow up 10 months after inclusion in the study</time_frame>
    <description>In non-diabetic participants with ischemic stroke the target of lipid lowering treatment was LDL&lt;2.5 mmol/l and &lt;2.0 mmol/l in case of diabetes</description>
  </other_outcome>
  <other_outcome>
    <measure>Intensification of preventive treatment</measure>
    <time_frame>From discharge from the stroke unit to final follow up in study</time_frame>
    <description>Proportion of participants who had an intensification of antihypertensive / lipid lowering medication since discharge</description>
  </other_outcome>
  <other_outcome>
    <measure>Adherence with preventive medication</measure>
    <time_frame>At follow up 10 months after inclusion in the study</time_frame>
    <description>Proportion of participants with at least 80% adherence with preventive medication</description>
  </other_outcome>
  <other_outcome>
    <measure>Healthy lifestyle</measure>
    <time_frame>At follow up 10 months after inclusion in the study</time_frame>
    <description>Proportion of participants on a healthy diet, moderate physical activity for four hours/week, smoking cessation in baseline daily smokers, reduction of an overuse of alcohol to recommended level</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to cardiovascular complications</measure>
    <time_frame>From inclusion in the study to a median of 65 (61-66) months after inclusion</time_frame>
    <description>Time to recurrent stroke, myocardial infarction and death in months</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initiation/stepwise escalation of antihypertensive medication in case of blood pressure above individual target Initiation/stepwise escalation of cholesterol lowering medication in case of LDL-cholesterol above individual target Advice on healthy lifestyle and life long adherence to preventive medication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants had the usual treatment: all patients were invited to one visit in the outpatient clinic three months after discharge with a diagnosis of stroke/TIA</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>Prevention of recurrent stroke, myocardial infarction and death Stepwise escalation of preventive medication Life style counselling including adherence to preventive treatment</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Patients diagnosed with a stroke during stay in the stroke unit of&#xD;
        Herlev Hospital&#xD;
&#xD;
        Exclusion Criteria: Severe stroke giving a modified Rankin Scale score &gt;4, severe cognitive&#xD;
        deficits or dementia, discharge to a nursing home&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nete Hornnes, MPH,Ph.d</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurology, Herlev Hospital, 2730 Herlev, Denmark</affiliation>
  </overall_official>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Herlev Hospital</investigator_affiliation>
    <investigator_full_name>Nete Hornnes</investigator_full_name>
    <investigator_title>Research Nurse</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03782857
org study id: 2012-41-0429
nct id: NCT03782857
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study evaluates the effect of early follow up in a preventive clinic with stepwise
      treatment of high blood pressure and lowering blood cholesterol. Half the participants were
      randomized to the preventive clinic group and the other half to control group with the usual
      treatment: one visit to the outpatient clinic three months after discharge with a diagnosis
      of stroke or transient ischemic attack (TIA)
Hypertension is the most important modifiable risk factor for recurrent stroke. Several
      studies have shown that less than 40% of stroke survivors are treated to target one year
      after stroke The investigator performed a feasibility study to test a model of treating this
      important risk factor in a hospital setting The investigator used a stepwise escalation of
      treatment of both blood pressure and blood cholesterol to individual targets according to
      patients' diagnosis of stroke, comorbidity and age
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants were randomized 1:1 to intervention or control group
primary purpose: Prevention
masking: None (Open Label)
measure: Blood pressure treated to target
time frame: At follow up 10 months after inclusion in the study
description: The investigator used individual targets of blood pressure: In case of hemorrhagic stroke: BP<130/80 mm Hg, in case of ischemic heart disease: BP target according to stroke diagnosis, but no lower than 130/80 mm Hg, in case of diabetes or chronic kidney disease: BP<130/80 mm Hg, age>80 years: <150/90 mm Hg, others: <140/90 mm Hg
measure: Reduction in blood pressure
time frame: At follow up 10 months after inclusion in the study
description: Difference between blood pressure at inclusion in the study and blood pressure measured at final follow up
measure: Reduction in LDL-cholesterol
time frame: At follow up 10 months after inclusion in the study
description: Difference between LDL-cholesterol at inclusion in the study and LDL-cholesterol measured at final follow up
measure: LDL-cholesterol treated to target
time frame: At follow up 10 months after inclusion in the study
description: In non-diabetic participants with ischemic stroke the target of lipid lowering treatment was LDL<2.5 mmol/l and <2.0 mmol/l in case of diabetes
measure: Intensification of preventive treatment
time frame: From discharge from the stroke unit to final follow up in study
description: Proportion of participants who had an intensification of antihypertensive / lipid lowering medication since discharge
measure: Adherence with preventive medication
time frame: At follow up 10 months after inclusion in the study
description: Proportion of participants with at least 80% adherence with preventive medication
measure: Healthy lifestyle
time frame: At follow up 10 months after inclusion in the study
description: Proportion of participants on a healthy diet, moderate physical activity for four hours/week, smoking cessation in baseline daily smokers, reduction of an overuse of alcohol to recommended level
measure: Time to cardiovascular complications
time frame: From inclusion in the study to a median of 65 (61-66) months after inclusion
description: Time to recurrent stroke, myocardial infarction and death in months
arm group label: Intervention group
arm group type: Experimental
description: Initiation/stepwise escalation of antihypertensive medication in case of blood pressure above individual target Initiation/stepwise escalation of cholesterol lowering medication in case of LDL-cholesterol above individual target Advice on healthy lifestyle and life long adherence to preventive medication
arm group label: Control group
arm group type: No Intervention
description: Participants had the usual treatment: all patients were invited to one visit in the outpatient clinic three months after discharge with a diagnosis of stroke/TIA
intervention type: Behavioral
intervention name: Intervention
description: Prevention of recurrent stroke, myocardial infarction and death Stepwise escalation of preventive medication Life style counselling including adherence to preventive treatment
arm group label: Intervention group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Nete Hornnes, MPH,Ph.d
role: Principal Investigator
affiliation: Department of Neurology, Herlev Hospital, 2730 Herlev, Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Herlev Hospital
investigator full name: Nete Hornnes
investigator title: Research Nurse
mesh term: Stroke
sharing ipd: No