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 @ 12:34 PM
Ignite Modification Date:
2025-12-24 @ 12:34 PM
NCT ID:
NCT03329261
Eligibility Criteria:
Inclusion criteria:
* Male or female aged between 18 to 75 years old.
* Proven ACS requiring PTCA within 1 week of inclusion. The ACS should be without ST-segment elevation (presence of chest pain with ST-segment or T-wave changes without sustained ST segment elevation) with elevation of cardiac biomarkers of MI (positive troponins).
* Coronary angiography showing at least one coronary lesion, whether mono, bi or multi-truncate
* Type 2 diabetes confirmed for at least one year
* Patient candidate for treatment with Clopidogrel
* Informed consent of patients
Non-Inclusion Criteria:
* Non-consenting patient and/or participating in another clinical study
* ACS with ST segment elevation (STEMI)
* History of digestive or cerebral bleeding with antiplatelet agents or anticoagulants
* Insulin-dependent diabetes mellitus (IDDM)
* Diabetic requiring insulin
* Patient in cardiogenic shock
* Patient under treatment with anti-glycoprotein IIb/IIIa or stopped less than 72 hours prior to inclusion
* Previously treated with clopidogrel or thrombolytics
* Patients programmed for surgery in less than 6 months
* Ischemic stroke less than 6 weeks old
* History of haemorrhagic stroke (regardless of time)
* Patients under or candidates for Vitamin K antagonist (VKA)
* Patients under another antiplatelet agent (Ticlopidine, Prasugrel)
* Patients with a contraindication to clopidogrel (hypersensitivity to the active substance or to any of the excipients, severe hepatic impairment, progressive hemorrhagic lesion such as peptic ulcer or intracranial hemorrhage)
* Under omeprazole treatment, or considered during the study
* Anemia (Hb \<12g/dl)
* Thrombocytopenia with less than 100000 cells/mm3
* Serum creatinine greater than 200 μmol/l
* Pregnancy and/or breast-feeding
* Severe renal impairment
Exclusion criteria:
* Non-compliance with treatment (treatment compliance \<80%)
* AE/SAE requiring cessation of treatment
* Planning a CABG
* Occurrence of pregnancy during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03329261
Study Brief:
Protocol Section:
NCT03329261