A Randomized Trial of Rosuvastatin Loading Combined With Early hydrAtion Versus Standard-of-care … (NCT03526367) | Clinical Trial Compass
WithdrawnPhase 4
A Randomized Trial of Rosuvastatin Loading Combined With Early hydrAtion Versus Standard-of-care Medications for the Prevention of CIAKI in Patient With AMI Undergoing Emergency PCI
Stopped: Study withdrawn for no sufficient fund support.
China0Started 2019-02-20
Plain-language summary
The CIAKI,as the third complication of PCI, was associated with adverse cardiac events after procedure. Moreover, because the rate of periprocedure hydration is inadequate in STEMI patients before primary PCI, the incidence of CIAKI is higher significantly in these patients. The cardiovascular pleiotropic effects of statins in addition to lipid have been widely concerned. The previous studies demonstrated usage of statin in periprocedure could decrease the risk of CIAKI. Compared with hydration, the usage of statin to prevention CIAKI show the advantages in clinical practice, for example，there is no need to consider the cardiac function.The optimal strategies for preventting CIAKI in STEMI patients undergoing primary PCI needed further studies to explore. What's more, whether a synergistic effect of hydration and statin or not is unknown.
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:
* Age 18-80 years old
* The STEMI patients within 12 h of onset(or within 12-24 h of onset with chest pain and persistent ST-segment elevation or the presence of a new LBBB);
* The patients planned primary PCI;
* At least one of the following:
Diabetes mellitus, Chronic Kidney Disease, Female, Elder(Age≥65), Hypertension class 3, Congestive heart failure
• Voluntary signature of informed consent
Exclusion Criteria:
* Type 2 Myocardial infarction secondary to an ischaemic imbalance
* Intolerance of statin or iodine contrast
* eGFR\<30ml/min
* Administration of any iodinated (e.g.CT angiography) within 14 days before enrollment
* Hepatic dysfunction, ALT 3 times greater than upper normal limit
* Thyreoid insufficiency
* Hemodynamic instability
* Have received PCI or CABG within 30 day before enrollment
* Plan to perform any coronary angiography or PCI within 30 days
* Have received any statins within 7 days before enrollment
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.