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

NCT00931788 | Completed Phase 4

• 1 other identifier: EPICORE 2009-003
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ischemic Stroke; Transient Ischemic Attacks

Keywords

Management of hypertension and cholesterol; stroke; TIA

Outcome Measures

Primary Outcomes (1)

• 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 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.

  6 months

Study Arms (2)

Intensive pharmacist case management

EXPERIMENTAL

Drug: Antihypertensive agents and lipid lowering therapy

Usual care

ACTIVE COMPARATOR

Other: Usual Care

Interventions

Antihypertensive agents and lipid lowering therapy DRUG

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

Intensive pharmacist case management

Usual Care OTHER

Monthly education and reinforcement of risk factor modification, and blood pressure measurement.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Alberta: lead
• Heart and Stroke Foundation of Canada: collaborator
• Alberta Heritage Foundation for Medical Research: collaborator

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (2)

• 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.

  PMID: 25458657 RESULT

• 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;186(8):577-84. doi: 10.1503/cmaj.140053. Epub 2014 Apr 14.

  PMID: 24733770 RESULT

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient; Stroke

Interventions

Antihypertensive Agents

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Finlay A McAlister, MD, MSc

  Department of Medicine, University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: July 2, 2009
• Study Start: January 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 15, 2018

Record last verified: 2015-04

Locations

CA (1)