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:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT01190904
Eligibility Criteria:
Inclusion Criteria:
* Male age \[18-75 years\];
* Type 2 Diabetes, defined according to the American Diabetes Association as history of: a) presence of classic symptoms of DM with unequivocal elevation of plasma glucose (2-hour post-prandial or random of \>200 mg/dL (11mmol/L), b) fasting plasma glucose elevation on more than 1 occasion of at least 126 mg/dL (7mmol/L) or c) HA1C \> 6.5, currently undergoing pharmacological or non-pharmacological treatment;
* Angiographically confirmed Coronary Artery Disease (≥50%) with or without PCI;
* Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia;
* Willingness to comply with all follow-up required study visits; and
* Signed and received copy of informed consent
Exclusion Criteria:
* Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment;
* Previous stroke within 6 months;
* Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during PCI/DES related anticoagulation;
* Acute ST-elevation MI (Q-wave) within 72 hours prior to enrollment requiring revascularization;
* Abnormal creatine kinase (CK \> 2x normal); or abnormal CK-MB levels at time of randomization;
* Contraindication to either CABG or PCI/DES because of a coexisting clinical condition\];
* Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis;
* Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine;
* Dementia with a Mini Mental Status Examination (MMSE) score of \<20;
* Extra-cardiac illness that is expected to limit survival to less than 5 years (e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease);
* Geographically inaccessible for follow-up visits required by protocol.
* Additional Ancillary Study Exclusions. Exclusion criteria that are unique to the proposed study are prior use of hormonal therapy (HRT) with testosterone in men at baseline and current use of sex-hormone antagonist medications at baseline.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01190904
Study Brief:
Protocol Section:
NCT01190904