Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:22 AM
Ignite Modification Date:
2025-12-25 @ 4:22 AM
NCT ID:
NCT02993120
Eligibility Criteria:
Inclusion Criteria:
Subject
* ≥ 18 years of age at signing of informed consent
* Undergoing treatment with a statin or other non-statin lipid lowering medication
* at least 1 planned visit in the next 12 months
* available for follow-up questionnaires
* established ASCVD defined as meeting at least 1 of the following criteria:
* coronary artery disease
* prior history of myocardial infarction
* coronary or other arterial revascularization
* ischemic stroke or transient ischemic attack
* documented peripheral arterial disease secondary to atherosclerosis (eg., aortic aneurysm, ankle brachial index \< 0.9, imaging evidence of \> 50% stenosis in any peripheral artery, or intermittent claudication)
* carotid artery stenosis
* LDL-C levels\>69 mg/dL except in subjects assigned to the PCSK9i cohort Cohorts
* Cohorts are assigned based upon most recent LDL-C level prior to enrollment
* For the cohort of approximately 500 subjects taking a PCSK9i at baseline: proof consisting of a current prescription for an approved PCSK9i and subject confirmation that they have taken a PCSK9i within 30 days prior to enrollment is necessary
* For the cohort of approximately 2000 subjects with LDL-C ≥ 100 mg/dL: confirmation of LDL-C ≥ 100 mg/dL with no change in LLT for 4 weeks.
* For the cohort of approximately 2500 subjects with LDL-C 70-99 mg/dL: confirmation of LDL-C 70-99 mg/dL with no change in LLT for 4 weeks.
Exclusion Criteria:
Subject
* Unable or unwilling to provide informed consent including but not limited to cognitive or language barriers
* Current or planned participation in an interventional clinical study involving any investigational medical device or drug treatment at the time of enrollment or in the 6 months prior to enrollment. Subjects who chose to participate in an interventional clinical study of either device or drug treatment after enrollment will be removed from the GOULD study
* Life expectancy \< 12 months
* Currently pregnant, breast feeding, or planning to become pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02993120
Study Brief:
Protocol Section:
NCT02993120