Guidelines Based Undertaking for Improvement in Dyslipidemia Related Events (GUIDE )
NCT ID: NCT00408057
Last Updated: 2008-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2500 participants
OBSERVATIONAL
2005-12-31
2007-11-30
Brief Summary
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Approximately 2,500 high-risk patients with an elevated LDL-C level (\> 2.5 mmol/L) will be enrolled. Patients meeting all inclusion criteria and having none of the exclusion criteria at Visit 1 (Screening) will be included in the study. Eligible patients that agree to participate and sign an informed consent will be treated with either statin therapy (increased or started or switched) or combination of statin and ezetimibe 10 mg (added/started) as per Study Schematic (Table 1) in order to achieve the recommended target of LDL\<2.5 mmol/L and providing that this treatment is in the best interest of the patient.
After enrollment there are a total of three scheduled clinic visits. All patients will have vital signs measured as well as a brief physical examination performed at Visit 1 (Screening).
At Visit 2 (6 weeks) patients with LDL-C \> 2.5mmol/L will be treated with either statin therapy increase or combination of statin and ezetimibe 10 mg (added/started) as per Study Schematic (Table 1) in order to achieve the recommended target of LDL\<2.5 mmol/L and providing that this treatment is in the best interest of the patient.
At Visit 3 (12 -18 weeks) patients with LDL \> 2.5 mmol/L will be treated with combination of statin and ezetimibe 10 mg as per Study Schematic (Table 1) in order to achieve the recommended target of LDL\<2.5 mmol/L and providing that this treatment is in the best interest of the patient.
At final Visit 4 (24-26 weeks) safety and efficacy of treatment will be reviewed. Following Visit 4 physicians will continue to treat these patients according to their clinical judgment.
Detailed Description
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Approximately 2,500 high-risk patients with an elevated LDL-C level (\> 2.5 mmol/L) will be enrolled. Patients meeting all inclusion criteria and having none of the exclusion criteria at Visit 1 (Screening) will be included. Eligible patients that agree to participate and sign an informed consent will be treated with appropriate treatment optimization including the use of ezetimibe on achieving Study Schematics (Table 1).
After enrollment there are a total of three scheduled clinic visits. Physicians may assess the patient between visit 2 and 3 if maximization of statin therapy is required.
At Visit 2 (6 weeks) patients with LDL \> 2.5mmol/L will be treated with either statin therapy (increased or started or switched) or combination of statin and ezetimibe 10 mg (added/started) as per Study Schematic (Table 1) in order to achieve the recommended target of LDL\<2.5 mmol/L and providing that this treatment is in the best interest of the patient.
At Visit 3 (12-18 weeks) patients with LDL \> 2.5 mmol/L will be treated with combination of statin and ezetimibe 10 mg (added/started) as per Study Schematic (Table 1) in order to achieve the recommended target of LDL\<2.5 mmol/L and providing that this treatment is in the best interest of the patient.
At final Visit 4 (24-26 weeks) safety and efficacy of treatment will be reviewed. Following Visit 4 physicians will continue to treat these patients according to their clinical judgment.
1.5.1 Treatment
During this observational study patients will be treated under standard care with either statin therapy and/or co-administered with ezetimibe 10 mg /day. This is an open label observational study, therefore patients and physicians will be aware of treatment allocation and the treatment chosen will be that in the best interests of the patient and according to the physician's preference. Treatment will begin at Visit 1- Screening/Baseline (Day 0) and will extend through Visit 4 (Week 24-26).
Based on patient's LDL-C level, at visit 1 (Screening/Baseline) patient will receive prescription of initial or increased dose of statin 10-80 mg/day and/or ezetimibe 10 mg/day for the following 6 weeks. At visit 2 (6 weeks F/U) patients will receive prescription of statin (dose increased) and/or ezetimibe 10 mg per day for the following 6 weeks based on their target level of LDL-C. At visit 3 (week 12 -18 F/U) for patients who did not reach their LDL-C target, ezetimibe 10 mg per day will be considered if appropriate for the patient for the following 14 weeks to complete the observational study.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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no intervention
no intervenion
Eligibility Criteria
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Inclusion Criteria
2. Patients with a diagnosis of primary hypercholesterolemia and who are defined as being "high risk" (10-year risk of coronary artery disease greater than 20 % based on the Framingham model and history of cardiovascular disease or)
3. Patients who have not reached their recommended LDL-C target levels of 2.5 mmol/L while on a statin alone.
4. According to the judgment of the treating physician patient enrollment is in the best interest of the patient.
5. Patient agrees to participate and signs an informed consent allowing follow up and sharing of patient related data.
Exclusion Criteria
2. Patients who have been treated with any investigational drug within 30 days prior to Visit 1. (If \<30 days, contact the clinical monitor for a case-by-case evaluation.)
3. Patients with clinically significant concomitant illnesses of liver, muscle or kidney abnormalities.
18 Years
ALL
No
Sponsors
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Merck Frosst Canada Ltd.
INDUSTRY
Schering-Plough
INDUSTRY
Canadian Heart Research Centre
OTHER
Responsible Party
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Canadian Heart Research Centre
Principal Investigators
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Lawrence Leiter, MD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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St. MIchael's Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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CHRC 020
Identifier Type: -
Identifier Source: org_study_id