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 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT00111566
Eligibility Criteria:
Inclusion Criteria:
* Male and non-pregnant female subjects
* 18 years of age or older
* Received aspirin, clopidogrel, heparin (unfractionated or low molecular weight \[LMW\]) and eptifibatide
* Had a successful PCI procedure with at least one stent deployed
* Availability of a hospital bed
Exclusion Criteria:
* Use of alternative anti-thrombin therapy during PCI (e.g. bivalirudin)
* High risk patients:
* Acute ST elevation MI \< 48 hours (either direct PCI or rescue PCI)
* Unprotected left main PCI
* Obvious large thrombus on angiography
* Use of rotablation, atherectomy, or thrombectomy devices
* Unsatisfactory PCI results:
* Final thrombolysis in myocardial infarction (TIMI) flow \< 3
* High grade dissection (\> type B, if not completely resolved at completion of PCI)
* Evident or suspected thrombus
* Distal embolization
* Suboptimal stenting (\> 20% residual stenosis)
* Side branch closure (≥ 1.5 mm branch or with associated symptoms)
* Abrupt closure during procedure (if prolonged \> 15 min or not resolved at completion of PCI)
* Clinical instability
* Prolonged ischemia during PCI (\> 15 min)
* Increased hazard of eptifibatide infusion:
* Unsatisfactory deployment of a closure device (if used)
* Large peri-procedure hematoma making the continuation of eptifibatide hazardous
* Any condition that will increase the hazard of continuing eptifibatide
* Operator discretion
* No informed consent
* Active participation in other research studies (unless with special exemption)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00111566
Study Brief:
Protocol Section:
NCT00111566