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 range

18 Years – 80 Years

Sex

ALL

See this in plain English?

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);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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