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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT00353067
Eligibility Criteria:
Inclusion Criteria:
* Men and women
* 35 years of age or older
* African American by self-report.
* A history of either acute MI or admission for unstable angina (UA)within 30 days of randomization
* Women who have undergone surgical sterilization (hysterectomy or bilateral tubal ligation or bilateral oophorectomy)or are \> 2 years post-menopausal by medical history are also eligible.
* Women of childbearing potential must have a negative urine pregnancy test and are required to use 2 barrier methods of contraception throughout the study.
* Patients are capable of understanding study procedures and agree to participate in the study including scheduled follow up visits and consent to genetic haplotype testing.
Exclusion Criteria:
* Presence of active, symptomatic HF defined by presence of New York Heart Association Class II-IV at time of screening.
* Received any treatment with an investigational agent or device within 4 weeks.
* Evidence of secondary angina or ischemia
* Underlying cardiac disorders that may cause cardiac ischemia including aortic stenosis or hypertrophic cardiomyopathy.
* Presence of active hepatic disease or AST and/or ALT \> 3.0 × ULN.
* Calculated creatinine clearance \< 30 ml/minute OR the presence of chronic and severe renal insufficiency.
* Major surgery performed within six weeks prior to scheduled day of randomization.
* Any other major intercurrent illness and other condition, which, in the opinion of the Investigator, will interfere with the patient's participation in the study or leads to a survival prognosis of \< 5 years.
* A history of additional risk factors for Torsades de Pointe (TdP)
* Patients who are not willing to return for follow up visits or with a known history of non-compliance.
* Patients who consume \> 3 alcoholic drinks/day or \> 15 drinks/week, or have a history of alcohol abuse within the past 2 years.
* History of active drug abuse within 1 year of screening for the study.
* Pregnant or lactating women.
* Poor mental function or any other reason that may cause difficulty in complying with the requirements of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT00353067
Study Brief:
Protocol Section:
NCT00353067