Preventing Recurrent Vascular Events in Patients With Stroke or Transient Ischemic Attack (PREVENTION)

October 10, 2018 updated by: University of Alberta

Preventing Recurrent Vascular Events and Neurological Worsening Through Intensive Organized Case-Management (PREVENTION) Trial

People who have had a stroke or transient ischemic attack (TIA or "mini-stroke") are at high risk of having another stroke or a heart attack. Conditions like high blood pressure and high cholesterol, along with other lifestyle behaviors (e.g., smoking), substantially increase the risk of stroke and heart disease. Aggressive treatment of these risk factors however, can significantly reduce the chance of another stroke, heart attack or death.

This study will look at different ways to optimize blood pressure and cholesterol levels and educate people about positive lifestyle changes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND: Epidemiological studies have shown that a number of conditions increase the risk of stroke and other vascular diseases and there is compelling evidence from large randomized trials that treatment of these risk factors, especially hypertension and high cholesterol, can significantly lower future cardiovascular risk. Survivors of TIA or stroke are at high risk for recurrent stroke, MI, or death (22% at one year) and aggressive treatment of vascular risk factors can reduce the risk of recurrence by over 25%. However, vascular risk factors, especially hypertension and high cholesterol, are not managed optimally in patients after a TIA or stroke, even in those patients seen in specialized Stroke Prevention Clinics (SPCs). This gap between the evidence for secondary prevention of stroke and the clinical reality leads to sub-optimal patient outcomes. There is limited data on interventions proven to improve outcomes in patients with stroke or TIA.

To improve the quality of care for any condition or patient population, one needs to address structure, process, and outcomes. In this study, we will be creating and testing a new structure for delivery of stroke prevention services - we anticipate this new structure will improve processes of care which in turn should lead to improved outcomes.

Hypothesis:

Compared with usual care, we hypothesize that a pharmacist case manager intervention will improve blood pressure and serum lipid levels (by employing standardized treatment protocols to guideline-recommended targets), the management of other risk factors,enhance medication adherence, and increase health-related quality of life.

Design:

A prospective, randomized, controlled open-label with blinded ascertainment of outcomes (PROBE) trial. Patients with a recent stroke or TIA evaluated in any of the 3 stroke prevention clinics (SPC) in Edmonton, Canada,will be randomized to usual care or the "pharmacist case manager intervention".

Usual care patients will will receive the same educational materials about stroke risk factors and medication adherence as the "intervention" patients, will be seen monthly by a study nurse, will have the same number of BP measurements as "intervention" patients, and will have a fax sent to their family physician after each study visit reporting their BP.

Over and above usual care, the intervention group will include intensive pharmacist case-management over 6 months consisting of the following:

  • monthly follow-up visits with focus on vascular protection; these clinic visits will be run parallel to, but independent of, any follow-up at the SPC and will include provision to each patient of their individual cardiovascular disease risk profile using the the CV Health Manager software.
  • Initiation, monitoring and titration of medications related to blood pressure and dyslipidemia, using Canadian national guideline-recommended treatment targets.
  • Medication adherence management on an ongoing basis, including access to Dosettes®, blister packs, and reminder tools as deemed necessary.
  • Independent capacity to refer to allied health services (including dieticians and weight loss services, diabetes education centres, and smoking cessation counselors).
  • Regular feedback to the primary care physician and the stroke specialist of record, regarding all stroke prevention related activities.

Study Type

Interventional

Enrollment (Actual)

279

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A stroke specialist-determined ischemic stroke or TIA within the past year (including ocular strokes/TIA such as amaurosis fugax).
  • Presence of systemic hypertension (average systolic blood pressure over two visits - i.e., SPC visit and study screening visit- exceeding 140 mmHg) OR fasting LDL cholesterol exceeding 2.0 mmol/L OR total: HDL cholesterol ratio exceeding 4.0 at SPC visit.

Exclusion Criteria:

  • Neurological event considered to be due to intracranial hemorrhage (e.g., ICH, SAH), or trauma induced, or related to structural heart disease such as ASD/VSD or endocarditis.
  • Foreshortened life-expectancy (e.g., active malignancy), hypertensive crisis (clinic systolic BP > 200 mm Hg), or severe comorbidities.
  • Institutionalized in a long-term care facility.
  • Cognitive impairment (defined as a score of > 5 on the Short Portable Mental Status questionnaire).
  • Already on maximal therapy for risk factors (on 3 antihypertensive drugs at maximal dose if hypertension is inclusion criterion or on maximal dose statin if hyperlipidemia is inclusion criterion).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care
Other: Usual Care
Monthly education and reinforcement of risk factor modification, and blood pressure measurement.
Experimental: Intensive pharmacist case management
Drug: Antihypertensive agents and lipid lowering therapy
The above agents will be initiated/titrated in accordance to guidelines approved by Canadian Hypertension Education Program and the Canadian Best Practice Recommendations for Stroke Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of subjects who attain "optimal BP and lipid control" (defined as systolic BP < 140 mm Hg AND fasting LDL cholesterol < 2.0 mmol/L) compared to baseline.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in systolic blood pressure (in mm Hg) and in LDL cholesterol (in mmol/L). Multiple other secondary outcomes as detailed in full protocol.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Heart and Stroke Foundation of Canada
Alberta Heritage Foundation for Medical Research

Investigators

  • Principal Investigator: Finlay A McAlister, MD, MSc, Department of Medicine, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

July 1, 2009

First Posted (Estimate)

July 2, 2009

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPICORE 2009-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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