Effect of Lantus and Apidra in Patients With Acute ST Elevation Myocardial Infarction (NCT00670228) | Clinical Trial Compass
TerminatedPhase 3
Effect of Lantus and Apidra in Patients With Acute ST Elevation Myocardial Infarction
Stopped: Due to Negative feasibility assessment of recruiting the planned number of subjects within the study timelines
United States, Argentina, Brazil34 participantsStarted 2008-04
Plain-language summary
Primary objective:
To demonstrate that in hyperglycemic subjects with anterior STEMI (ST Elevation Myocardial Infarction) undergoing Percutaneous Coronary Intervention (PCI), tight glycemic control using insulin glulisine and insulin glargine, i.e. Intensive Insulin Therapy (IIT), results in reducing infarct size at day 60 versus (vs) Standard Glycemic Care (SGC).
Secondary objectives:
To demonstrate that tight glycemic control using insulin glulisine and insulin glargine reduces markers of inflammation and improves Left Ventricular (LV) function and Cardio-Vascular (CV) outcomes from baseline values, in hyperglycemic subjects with STEMI undergoing Percutaneous Coronary Intervention (PCI).
Who can participate
Age range
35 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:
* Men or women = or \> 35 years of age presenting to the hospital with hyperglycemia (plasma glucose \>140 mg/dL) and Primary Anterior wall ST-Elevation Myocardial Infarction (AW STEMI)
* No history of illicit drug abuse in past year
* A minimum of 30 minutes but \< or = 6 hours of continuous pain/symptoms immediately prior to presentation
* Subjects who will undergo primary percutaneous coronary intervention (PCI)
* At least 2 contiguous precordial leads demonstrating at least 2 mm of ST-segment elevation consistent with anterior wall MI
* Signed informed consent and HIPAA documentation (US only) prior to participation in the study
* Subjects ability and willingness to adhere to and be compliant with study protocol
Exclusion Criteria:
* A prior history of Myocardial Infarction (MI)
* Subjects who have received any thrombolytic therapy during the current hospital admission
* Severe Heart Failure or cardiogenic shock (Killip class 3 or 4) by history or present at the time of screening
* Subjects with a plasma glucose \>400 mg/dL or diabetic ketoacidosis (DKA)
* History of Type 1 diabetes
* Active bleeding
* Active malignancy, chronic or other medical conditions likely to result in death over the next one year
* Recent hypotension requiring inotropic support in the past 30 days
* Participation in another clinical research study in the past 30 days
* Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study e…
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
1
Infarct Size Absolute Change From Baseline at Day 60