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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT03300167
Eligibility Criteria:
Inclusion Criteria:
* Aged over 18 years
* Admitted to hospital with non-ST-elevation ACS and plan for either coronary angiography with a view to PCI if appropriate or PCI following coronary angiography at a referring hospital
* Current treatment with aspirin and ticagrelor or, if ticagrelor is not tolerated, prasugrel (DAPT)
* Ability to give informed consent
Exclusion Criteria:
* Treatment with antiplatelet medication apart from aspirin, ticagrelor, prasugrel or clopidogrel in the last 10 days (e.g. dipyridamole, abciximab, tirofiban).
* Planned use of a glycoprotein IIb/IIIa antagonist for the PCI procedure.
* Patients with haemodynamic instability, shock or angiographic evidence of intracoronary thrombus.
* Current use of an oral anticoagulant (e.g. warfarin, dabigatran, rivaroxaban, apixaban).
* Clinically significant liver disease.
* Contraindication or allergy to unfractionated heparin.
* Receiving immunosuppressant medication (eg. cyclosporin, tacrolimus, mycophenolate, azathioprine).
* Administration of doses of low molecular weight heparin or fondaparinux in the 12 hours preceding PCI.
* Known severe left ventricular dysfunction (ejection fraction \<30%).
* Culprit lesion in left main coronary artery.
* Women of childbearing potential unless pregnancy has been excluded during the index hospital admission.
* Known serum creatinine above upper limit of local reference range.
* Subjects with known active chronic inflammatory disease, e.g. systemic lupus erythematosus, rheumatoid arthritis, seropositive arthropathies and known seropositivity to HIV, Hepatitis B or Hepatitis C.
* Severely diseased, excessively tortuous or calcified coronary vessels that increase the risk of snaring the LBS.
* Culprit lesion in a coronary vessel with a reference diameter of less than 2.5 mm.
* Need to cross a region of coronary vessel that contains a stent.
* Evidence of ongoing sepsis.
* Receiving a non-steroidal anti-inflammatory drug (NSAID) apart from aspirin, including selective COX2 inhibitors ('coxibs') and including regular or intermittent/as required use.
* Receiving a strong inhibitor of CYP3A4 (eg, ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin \[but not erythromycin or azithromycin\], nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, or over 1 litre daily of grapefruit juice).
* Receiving simvastatin or lovastatin at doses higher than 40 mg daily.
* Receiving a CYP3A substrate with a narrow therapeutic index (e.g. cyclosporine or quinidine).
* Receiving a strong inducer of CYP3A (e.g. rifampin/rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital).
* Current or recent (within 30 days) participation in a clinical trial of a drug or device or any other clinical study that might influence the results or safety of the study.
* Any factor precluding ability to comply with follow-up.
* Any other factor judged by the investigator or treating physician to preclude enrolment in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03300167
Study Brief:
Protocol Section:
NCT03300167