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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT02284503
Eligibility Criteria:
Inclusion Criteria:
1. 18-80 year old males and non-child-bearing period females.
2. Clinical diagnosed with NSTE-ACS, including unstable angina or non-ST-segment elevation myocardial infarction(NSTEMI).
* For unstable angina, the diagnose should meet all below:
Clinical onset features: angina for at least 20 min when resting; initial onset angina pectoris(new onset within one month) manifests spontaneous angina or labor angina (CCS grade II or III); Symptoms of original stable angina pectoris aggravate in one month and at least achieve CCS grade III (accelerated angina pectoris); angina onset within one month after MI.
ECG: At least twice in one month: ST depression or elevation \>0.1millivolt (mv) or T-wave inversion ≥0.2 mv in 2 or more contiguous electrocardiographic leads when onset and the ST-T changes recovered after remission of chest pain. Myocardial damage marker do not elevate or reach the MI diagnostic level.
* For NSTEMI, the diagnose should meet all below ischemia symptoms(ischemic chest pain lasting more than 30 min and cannot relief significantly by sub-lingual NTG) ECG change: new ST-T dynamic development (new or transient ST depression ≥0.1mv or T-wave inversion≥0.2mv).
Myocardial damage marker level is normal or elevated to the MI diagnostic level.
3. Received early (within 48 h) Percutaneous Coronary Intervention(PCI).
4. Should be statin- naïve(last 3 months).
5. Only receive drug-eluting stents.
6. Sign the Informed Consent Form(ICF)
Exclusion Criteria:
Any of the following is regarded as a criterion for exclusion from the study:
1. Diagnosis as STEMI;
2. NSTE-ACS with high-risk features warranting emergency coronary angiography;
3. Receive only medical therapy or Coronary Artery Bypass Graft(CABG)
4. Active liver disease or dysfunction including agnogenic serum transaminase sustained elevation or higher than 3 times upper limit of normal(ULN);
5. Left ventricular ejection fraction\<30%;
6. Previous or current treatment with statins;
7. Patients with myopathy or serum creatine kinase \> 5 times the upper limit of normal not caused by myocardial injury;
8. Severe renal function damage (creatinine clearance rate\<30 ml/min);
9. Severe anemia (haemoglobin\< 6g/L);
10. Diagnosed with malignancy within 5 years;
11. Concurrent use ciclosporin；
12. Investigator evaluated as not appropriate for statins.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02284503
Study Brief:
Protocol Section:
NCT02284503