TerminatedPhase 2

A Study to Explore the Efficacy of Alprostadil Liposomes Injection in the Prevention of CI-AKI

Stopped: Voluntarily suspended the trial due to strategic adjustments

China132 participantsStarted 2022-10-20

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Cardiac function class NYHA class III;
✓. Age \> 75 years old;
✓. Anemia (baseline hematocrit: \<36% in women, \<39% in men);
✓. Diabetes.

Exclusion criteria

✕. Pre-perform emergency PCI;
✕. Previously allergic to alprostadil similar products and contrast agents; used alprostadil within 3 days before the first administration;
✕. Severe renal insufficiency: renal replacement therapy may be performed in a short period of time or eGFR\<30 mL/(min·1.73m\^2);
✕. Severe heart failure (LVEF \<35% or NYHA class IV), acute heart failure, and pulmonary edema;
✕. Requires mechanical circulatory support therapy (intra-aortic balloon pump, catheter-based ventricular assist device, venous-arterial extracorporeal membrane oxygenation therapy, etc.);
✕. Hypotension: systolic blood pressure \< 90 mmHg;
✕. Acute bleeding disorders or bleeding tendency, and the investigators believe that they are not suitable to participate in this trial;
✕. Severe anemia (hemoglobin \<60 g/L);

What they're measuring

Incidence of contrast-induced acute kidney injury within 72 hours after PCI

Timeframe: from baseline to 72 hours after PCI

Trial details

NCT IDNCT05475717

SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-04

View on ClinicalTrials.gov More Contrast-induced Acute Kidney Injury trials