Ischemic StrokePhase 4PREVENTIONNCT00931788
Preventing Recurrent Vascular Events in Patients With Stroke or Transient Ischemic Attack
A Phase 4 study testing Antihypertensive agents and lipid lowering therapy in people with Ischemic Stroke and Transient Ischemic Attacks, run by University of Alberta at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attacks
- What is being tested?
- Antihypertensive agents and lipid lowering therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2009to Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke, Transient Ischemic Attacks
- Being tested
- Antihypertensive agents and lipid lowering therapy, Usual Care
- Keywords
- Management of hypertension and cholesterol, stroke, TIA
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antihypertensive agents and lipid lowering therapyDrug
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
Usual CareOther
Monthly education and reinforcement of risk factor modification, and blood pressure measurement.
| Study group | Role | What they receive |
|---|---|---|
| Intensive pharmacist case management | Experimental | Not described Receives: Drug: Antihypertensive agents and lipid lowering therapy |
| Usual care | Active comparator | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Change in systolic blood pressure (in mm Hg) and in LDL cholesterol (in mmol/L). Multiple other secondary outcomes as detailed in full protocol.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Alberta Heritage Foundation for Medical Research
- Responsible party
- Sponsor
- Investigators
- Finlay A McAlister, MD, MSc, Principal investigator, Department of Medicine, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931788
- Sponsor's protocol ID
- EPICORE 2009-003
- Acronym
- PREVENTION
- Status last verified
- Apr 2015
- First submitted
- 5 Jun 2009
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
McAlister FA, Grover S, Padwal RS, Youngson E, Fradette M, Thompson A, Buck B, Dean N, Tsuyuki RT, Shuaib A, Majumdar SR. Case management reduces global vascular risk after stroke: secondary results from the The preventing recurrent vascular events and neurological worsening through intensive organized case-management randomized controlled trial. Am Heart J. 2014 Dec;168(6):924-30. doi: 10.1016/j.ahj.2014.08.001. Epub 2014 Aug 7.
PubMed 25458657McAlister FA, Majumdar SR, Padwal RS, Fradette M, Thompson A, Buck B, Dean N, Bakal JA, Tsuyuki R, Grover S, Shuaib A. Case management for blood pressure and lipid level control after minor stroke: PREVENTION randomized controlled trial. CMAJ. 2014 May 13;186(8):577-84. doi: 10.1503/cmaj.140053. Epub 2014 Apr 14.
PubMed 24733770
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Recurrent Vascular Events and Neurological Worsening Through Intensive Organized Case-Management (PREVENTION) Trial
- ClinicalTrials.gov ID
- NCT00931788
- Acronym / sponsor ID
- PREVENTION / EPICORE 2009-003
- Conditions
- Ischemic Stroke, Transient Ischemic Attacks
- Keywords
- Management of hypertension and cholesterol, stroke, TIA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Alberta Heritage Foundation for Medical Research
- Study start
- Jan 2009
- Primary completion
- May 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive pharmacist case management | Experimental | Drug: Antihypertensive agents and lipid lowering therapy |
| Usual care | Active comparator | Other: Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antihypertensive agents and lipid lowering therapyThe 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 | Drug | Intensive pharmacist case management |
| Usual CareMonthly education and reinforcement of risk factor modification, and blood pressure measurement. | Other | Usual care |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Results publication: PubMed 25458657McAlister FA, Grover S, Padwal RS, Youngson E, Fradette M, Thompson A, Buck B, Dean N, Tsuyuki RT, Shuaib A, Majumdar SR. Case management reduces global vascular risk after stroke: secondary results from the The preventing recurrent vascular events and neurological worsening through intensive organized case-management randomized controlled trial. Am Heart J. 2014 Dec;168(6):924-30. doi: 10.1016/j.ahj.2014.08.001. Epub 2014 Aug 7.
- Results publication: PubMed 24733770McAlister FA, Majumdar SR, Padwal RS, Fradette M, Thompson A, Buck B, Dean N, Bakal JA, Tsuyuki R, Grover S, Shuaib A. Case management for blood pressure and lipid level control after minor stroke: PREVENTION randomized controlled trial. CMAJ. 2014 May 13;186(8):577-84. doi: 10.1503/cmaj.140053. Epub 2014 Apr 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Finlay A McAlister, MD, MSc principal investigator
Department of Medicine, University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antihypertensive agents and lipid lowering therapy in people with Ischemic Stroke and Transient Ischemic Attacks, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00931788, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.