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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT02201667
Eligibility Criteria:
Inclusion Criteria:
For inclusion in the study subjects should fulfill the following criteria:
1. Provision of informed consent prior to any study specific procedures;
2. Men or women \> 18 years of age, with documented evidence of non-ST segment elevation Acute Coronary Syndrome(ACS) in the 24 hours before randomisation;
3. Hospitalized for high-risk non-ST segment elevation Acute Coronary Syndrome(ACS)(GRACE risk score\>140) with indication for early percutaneous coronary intervention (PCI) according to 2012 Chinese non-S T segment elevation Acute Coronary Syndrome(ACS) guideline recommendation.
Exclusion Criteria:
Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
1. Evidence of cardiac rupture;
2. History of major hemorrhage (intracranial, gastrointestinal, etc.);
3. Active pathological bleeding;
4. Acute or chronic hematologic disorder including a Hemoglobin less than 10 g/L or a platelet count less than 10×109/L before procedure;
5. Contraindication against the use of clopidogrel and ticagrelor;
6. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
7. Severe complication 7.1 Other diseases with life expectancy ≤12 months; 7.2 Any history of Severe renal or hepatic dysfunction(hepatic failure, cirrhosis, portal hypertension and active hepatitis); Neutropenia, thrombocytopenia ; Known acute pancreatitis; 7.3 Arterial aneurysm, arterial/venous malformation and aorta dissection;
8. Complex heart condition 8.1 PCI within previous 1 month or Previous coronary-artery bypass surgery(CABG); 8.2 History of myocardial infarction; 8.3 Previously known multivessel coronary artery disease not suitable for percutaneous coronary intervention (PCI);
9. Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days;
10. Treatment with anticoagulants;
11. Pregnancy or lactating;
12. Body weight \<40kg or \>125kg;
13. Known hypersensitivity to any drug that may appear in the study;
14. Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02201667
Study Brief:
Protocol Section:
NCT02201667