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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT01916720
Eligibility Criteria:
Inclusion Criteria:
* Male or female, \>35 years of age
* Females of childbearing potential must be using approved contraceptive measures
* Male patients must be willing to abstain from sexual intercourse or use a form of contraception if engaging in sexual intercourse with a woman who could become pregnant
* Planned carotid endarterectomy within a timeframe compatible with recruitment for the study and able to comply with the requirements of the study, as deemed by the investigator
* Written, informed consent to participate
Exclusion Criteria:
* Recent myocardial infarction (within the previous 4 weeks)
* Currently taking corticosteroids, warfarin, digoxin or a potent CYP3A4 inhibitor
* Recent (\<3 months) or ongoing acute infection or significant trauma associated with bruising and/or taking antibiotics. Prophylactic antibiotics for surgery are allowed
* Change in dose of lipid-lowering therapy during the previous 4 weeks from randomisation
* History of chronic liver disease (e.g. cirrhosis, hepatitis) OR ALT OR AST ≥1.5 times the upper limit of normal (ULN) at screening
* Diagnosis of systemic lupus erythematosis (SLE) or rheumatoid arthritis (RA)
* Clinically significant anaemia
* History of severe renal impairment (serum creatinine \>1.8mg/dL)
* Unstable angina
* History of asthma , anaphylaxis or anaphylactoid reactions, severe allergic responses
* Abuse of alcohol or drugs within the last 6 months
* Any factor or clinical disease state that, in the investigator's opinion, would preclude completion of a safe surgical procedure and/or completion of the study
* Use of an investigational drugs within 30 days or 5 half-lives of their last dose prior to starting the study, whichever is the longest
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT01916720
Study Brief:
Protocol Section:
NCT01916720