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 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT00604695
Eligibility Criteria:
Inclusion Criteria:
* Subjects (men or women) at least 18 years and less than 75 years of age and
* Ischemic discomfort ≥20 minutes and ≤6 hours of duration and
* ST elevation ≥1mm (≥0.1mV) in two contiguous limb leads OR ≥2mm (≥0.2mV) in two contiguous precordial leads and
* Occluded infarct-related artery (TIMI Flow Grade 0 or 1) at the time of coronary angiography and
* Planned primary PCI within 2 hours of hospital presentation and
* Planned or concomitant use of aspirin, clopidogrel, unfractionated heparin, and Glycoprotein IIb/IIIa inhibition with intent to stent the infarct-related artery and
* Informed consent able to be obtained
Exclusion Criteria:
CLINICAL
* Age ≥75 years
* Maximal systolic blood pressure \<80 mmHg AFTER initial fluid and/or pressor resuscitation.
* Uncontrolled hypertension (SBP \>180 OR DBP \>110) at time of enrollment.
* Cardiac arrest or arrhythmia requiring chest compressions or cardiopulmonary resuscitation.
* Known pregnancy.
BIOCHEMICAL
* Known thrombocytopenia (platelet count \<100,000)
* Known severe renal insufficiency (creatinine \>4.0 mg/dL).
INCREASED BLEEDING RISK
* Active internal bleeding
* Recent (\<3 months) gastrointestinal hemorrhage
* Recent intracranial or intraspinal surgery, trauma, major surgery, or biopsy of a parenchymal organ (\< 1 month)
* Known coagulopathy, platelet disorder, or history of thrombocytopenia
* Current warfarin therapy
* Known neoplasm
* Any known history of transient ischemic attack, cerebrovascular accident, or active intracranial pathology including arteriovenous malformation or aneurysm
MEDICATIONS
* Administration of a fibrinolytic agent within 72 hours
* Known allergy or contraindication to fibrinolytics OR aspirin OR heparin OR clopidogrel
ANGIOGRAPHIC
* Left Main Coronary artery culprit lesion
* Ostial culprit lesion (ostium of LAD, LCX, or RCA).
* Lesion in non-native coronary artery (e.g. saphenous vein graft, arterial conduit graft)
* Subjects requiring urgent coronary artery bypass grafting
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT00604695
Study Brief:
Protocol Section:
NCT00604695