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 @ 2:35 AM
Ignite Modification Date:
2025-12-25 @ 2:35 AM
NCT ID:
NCT02147834
Eligibility Criteria:
Inclusion Criteria:
* Stable patients \>= 18 years of age referred for cardiac catheterization for evaluation of cardiac symptoms ( angina, fatigue, or shortness of breath)
* At least 1 indeterminate stenosis (20-80%), fractional flow reserve (FFR) \>=0.8 and PCI deferred
Exclusion Criteria:
* Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) during the index procedure or anticipated within the next month
* acute coronary syndrome or cardiogenic shock
* use of strong inhibitors of CTP3A (i.e. ketoconazole, itraconazole, clarithromycin,nefazodone, nelfinavir, ritonavir, indinavir and saquinavir)
* use of inducers of CYP3A (i.e. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort)
* liver cirrhosis
* sever renal insufficience (i.e. creatinine clearance \< 30mL/min/1.73 m2)
* QTc \> 500 milliseconds
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02147834
Study Brief:
Protocol Section:
NCT02147834