This is a multicenter, randomized, open-label phase II clinical trial to evaluate alprostadil liposomal injection in the prevention of contrast-induced acute kidney injury in patients undergoing percutaneous coronary intervention.
The trial is a multicenter, randomized, open-label, two-stage study. The trial period includes a screening period (up to 14 days), a treatment period (4 days), and a safety follow-up period (7 days ± 3 days). At least 368 patients with pre-PCI (percutaneous coronary intervention) are expected to be included, and all patients will be contrasted with non-ionic hypotonic/isotonic contrast media. The trail will be divided into two stages. Three dose groups are set in the first stage: 20 µg/day, 40 µg/day and 80 µg/day. In the first stage, on the basis of hydration prevention, patients will randomized to receive 20, 40 or 80 µg/day of alprostadil liposome injection for 4 days (1 to 3 hours before surgery and 3 days after surgery), once a day. The blank control group will only receive hydration prophylaxis. In the second stage, according to the comprehensive evaluation of the data in the first stage, a dose group will be selected to continue to be enrolled. The primary outcome measure is the incidence of contrast-induced acute kidney injury within 72 hours after PCI. During the administration of alprostadil liposomal injection, vital signs, physical examination, ECOG performance status, laboratory test, ECG, adverse events and PK parameters will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
132
Alprostadil liposome injection, iv drip, QD×4 days (1 to 3 hours before surgery and 3 days after surgery)
Beijing University First Hospital
Beijing, Beijing Municipality, China
Incidence of contrast-induced acute kidney injury within 72 hours after PCI
Incidence of contrast-induced acute kidney injury within 72 hours after PCI
Time frame: from baseline to 72 hours after PCI
Changes in serum creatinine from baseline at 24 hours, 48 hours, and 72 hours after angiography
Changes in serum creatinine from baseline at 24 hours, 48 hours, and 72 hours after angiography
Time frame: from baseline to 72 hours after angiography
Changes in blood urea nitrogen from baseline at 24 hours, 48 hours, and 72 hours after angiography
Changes in blood urea nitrogen from baseline at 24 hours, 48 hours, and 72 hours after angiography
Time frame: from baseline to 72 hours after angiography
Changes in cystatin C from baseline at 24 hours, 48 hours, and 72 hours after angiography
Changes in cystatin C from baseline at 24 hours, 48 hours, and 72 hours after angiography
Time frame: from baseline to 72 hours after angiography
Changes in hs-CRP from baseline at 24 hours, 48 hours, and 72 hours after angiography
Changes in hs-CRP from baseline at 24 hours, 48 hours, and 72 hours after angiography
Time frame: from baseline to 72 hours after angiography
Changes in IL-6 from baseline at 24 hours, 48 hours, and 72 hours after angiography
Changes in IL-6 from baseline at 24 hours, 48 hours, and 72 hours after angiography
Time frame: from baseline to 72 hours after angiography
Incidence of renal replacement therapy after angiography during the study period
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Incidence of renal replacement therapy after angiography during the study
Time frame: from baseline to 7 days after last dose
Adverse events
Adverse events from baseline to 7 days after last dose, including symptoms, Abnormal laboratory test
Time frame: from baseline to 7 days after last dose
Incidence of major adverse cardiovascular events (MACE) during the study period (recurrent angina, nonfatal myocardial infarction, acute heart failure, ventricular fibrillation, cardiac death)
Incidence of major adverse cardiovascular events (MACE) during the study period (recurrent angina, nonfatal myocardial infarction, acute heart failure, ventricular fibrillation, cardiac death)
Time frame: from baseline to 7 days after last dose