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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT00984802
Eligibility Criteria:
Inclusion Criteria:
* Subjects who have stable coronary artery disease undergoing elective PCI.
* Female subjects not of child-bearing potential.
* Absence of ST segment depression \>1.0 mm and absence of ST elevation \>1.0 mm in any lead on the baseline 12-lead ECG.
* subjects with CK-MB and troponin-T levels lower than the upper limit of normal.
* Subjects free of acute injuries or illnesses.
Exclusion Criteria:
* Subjects with unstable angina (angina at rest, worsening frequency, duration of angina) or other signs of unstable coronary artery disease.
* Subjects who had had an MI within 14 days prior to the PCI procedure.
* Subjects with conditions that contraindicate the PCI (e.g. coagulopathy, valvular disease, PVD).
* Subjects with history of TIA/stroke within 90 days or any intracranial bleed.
* Subjects with creatinine clearance ≥ 1.5 times the upper limit of normal.
* Subjects with an active history of psychiatric disorders that is likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements.
* Subjects with a history of alcohol or drug abuse.
* Subjects with documented history of human immunodeficiency virus (HIV), or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
* Subjects with uncorrected clinically significant abnormalities of clinical laboratory tests who in the investigators opinion will interfere with the study conduct.
* Subject with chronic diseases considered by the anesthetist unfit for surgery and/or who in the opinion of the investigator will increase the risk of the study or obscure the interpretation of results.
* Subjects who have participated in a clinical study within 1 month or are currently participating in a clinical study of an investigational agent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00984802
Study Brief:
Protocol Section:
NCT00984802