Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367991
Status:
COMPLETED
Last Update Posted:
2018-01-12
First Post:
2006-08-23
Brief Title:
Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if a naturally-occurring hormone called erythropoietin changes the action of platelets in the blood Patients with heart attacks are treated with medicines to reduce the clotting action of platelets This study is trying to determine whether erythropoietin alters the clotting action of platelets in patients receiving anti-platelet medicines It is important to understand the effects of erythropoietin on platelets since preliminary studies in animals suggest that erythropoietin may protect the heart from damage during a heart attack
Detailed Description:
Anti-apoptotic effects of erythropoietin in experimental myocardial infarction MI and ischemia-reperfusion injury suggest potential for therapeutic benefit in patients with acute MI Before the therapeutic potential of recombinant human erythropoietin rHuEpo in acute MI can be tested in large clinical trials more information on the effects of short-term rHuEpo on platelet function are needed Accordingly the current proposal aims to determine the effects of rHuEpo at a dose previously shown not to inhibit the anti-platelet effects of aspirin and clopidogrel in healthy subjects on platelet function and other safety measures and measure of infarct size in patients with acute coronary syndromes receiving clinically-indicated standard anti-platelet therapy with aspirin clopidogrel and glycoprotein Iib-IIIa inhibitors
Specific Aim 1 To determine the effects of intravenous rHuEpo 400 Ukg daily for 3 days vs placebo on in vivo and in vitro platelet function in patients with acute MI undergoing percutaneous revascularization
Specific Aim 2 To obtain pilot data to estimate the effects of administration of rHuEpo 400 Ukg daily for 3 days vs placebo on biochemical markers of myocardial infarction size and left ventricular ejection fraction in patients with acute MI undergoing percutaneous revascularization
Specific Aim 1 To determine the effects of intravenous rHuEpo 400 Ukg daily for 3 days vs placebo on in vivo and in vitro platelet function in patients with acute MI undergoing percutaneous revascularization
Specific Aim 2 To obtain pilot data to estimate the effects of administration of rHuEpo 400 Ukg daily for 3 days vs placebo on biochemical markers of myocardial infarction size and left ventricular ejection fraction in patients with acute MI undergoing percutaneous revascularization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0555844T | None | None | None |