Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT00408057
Brief Summary:
This is a multi-center, open label observational study conducted over 26 weeks.
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:
Overview This is a Quality Enhancement Research Initiative (QERI) whereby physicians are provided guidelines and easy to follow steps for their achievement..
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.
Study:
NCT00408057
Study Brief:
Protocol Section:
NCT00408057