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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT02808351
Eligibility Criteria:
Inclusion Criteria:
* Planned diagnostic coronary or peripheral artery angiography
* Type 2 diabetes mellitus
* CKD stages ≥2
* Statin naive, or not on statin treatment for at least 14 days
* Withdrawal metformin or aminophylline for 48h before angiography
* Total iodixanol volume
Exclusion Criteria:
* Hypersensitivity to iodine-containing compounds and berberine
* Ketoacidosis
* Lactic acidosis
* CKD stages 1, 5 (eGFR≥90ml/min per 1.73m2 or eGFR\<15ml/min per 1.73m2)
* STEMI
* NYHA class IV or hemodynamic instability
* Administration of any iodinated contrast medium within 14 days before randomization
* LDL-C\<1.82mmol/L（70mg/dL）
* Hepatic dysfunction (ALT 3 times greater than upper normal limit)
* Thyreoid insufficiency
* Renal artery Stenosis(unilateral \>70％ or bilateral stenosis\>50％)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02808351
Study Brief:
Protocol Section:
NCT02808351