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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT01463150
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years old
2. Patients having PCI with stenting 24 hours prior randomization, meeting the following criteria :
* Acute coronary syndrome (unstable angina or myocardial infarction)
* TIMI risk score\>2
3. Platelet reactivity in PRU ≥235 24 hours post-PCI
4. Age≥75 years and/or weight\<60 Kg
4\. Informed consent obtained in writing
Exclusion Criteria:
* A history of bleeding diathesis
* Chronic oral anticoagulation treatment
* Contraindications to antiplatelet therapy
* Known platelet function disorders
* PCI or coronary artery bypass surgery \< 3 months
* Unsuccessful PCI (residual stenosis \> 30% or flow \< Thrombolysis in myocardial infarction flow 3)
* Planned staged PCI in the next 30 days
* Hemodynamic instability
* hemodialysis
* Creatinine clearance \<25 ml/min
* inability to give informed consent
* High likelihood of being unavailable for the Day 30
* History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
* Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on longterm antiplatelet therapy.
* Any previous history of ischemic stroke, transient ischemic attack, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
* Thrombocytopenia (\<100.000 / μL) at randomization
* Anaemia (Hct \<30%) at randomization
* Polycythaemia (Hct \> 52%) at randomization
* Periprocedural IIb/IIIa inhibitor administration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
95 Years
Study:
NCT01463150
Study Brief:
Protocol Section:
NCT01463150