Ischemic Stroke Clinical Trial
— PREVENTIONOfficial title:
Preventing Recurrent Vascular Events and Neurological Worsening Through Intensive Organized Case-Management (PREVENTION) Trial
Verified date | April 2015 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 279 |
Est. completion date | November 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta Hospital | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta | Alberta Heritage Foundation for Medical Research, Heart and Stroke Foundation of Canada |
Canada,
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 ne — View Citation
McAlister 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 months | ||
Secondary | Change in systolic blood pressure (in mm Hg) and in LDL cholesterol (in mmol/L). Multiple other secondary outcomes as detailed in full protocol. | 6 months |
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