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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT01961856
Eligibility Criteria:
Inclusion Criteria:
* Age 18-80 years old
* Patients with STEMI (pain onset \<12 hours) undergoing primary PCI
* P2Y12 inhibitor naive
* Written informed consent
Exclusion Criteria:
* Peri-procedural IΙb/IIIa inhibitor administration
* Cardiogenic shock/hemodynamic instability
* Pseudo-aneurism, retroperitoneal hematoma, major bleeding (need for transfusion or Hb decline≥5 gr/ dl)
* Need for anticoagulant treatment
* Current or future administration of other thienopyridines or ADP receptor inhibitors
* Known thrombocytopenia (\<100.000 / μL) at randomization
* Hct \<30% or Hct \> 52% during randomization
* Known allergy to clopidogrel or ticagrelor
* Recent (\< 6 weeks) major operation, including CABG
* History of bleeding disorders
* Known intracranial mass, arteriovenous shunt or aneurism
* Previous intracranial bleeding
* INR\>1,5
* Other clinical conditions associated with increased bleeding risk, according to the investigators' judgment
* Known creatinine Clearance \<30ml/h at randomization or hemodialysis
* Severe/moderate liver failure
* Pregnancy/ breastfeeding
* Increased risk for bradyarrhythmias, according to the investigator's judgment
* Administration of potent CYP3A inhibitor (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice N1 L/d), substrates of CYP3A with narrow therapeutic range (cyclosporine, quinidine), or potent CYP3A inducers (rifampin /rifampicin, phenytoin, carbamazepine)
* Severe uncontrolled chronic obstructive pulmonary disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01961856
Study Brief:
Protocol Section:
NCT01961856