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| ID | Type | Description | Link |
|---|---|---|---|
| 0555844T |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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 U/kg 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 U/kg 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | recombinant human erythropoietin 200 U/kg IV daily for 3 days |
|
| B | Placebo Comparator | Normal saline volume to match active treatment IV daily for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant human erythropoietin alfa (drug) | Drug | 200 U/kg IV daily for 3 days vs. matched volume of normal saline IV daily for 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding Time | An integrated measure of in vivo platelet function and tissue hemostasis. | Change from Day 3 to Day 10 |
| Platelet Function Assay Closure Time | Change from Day 3 to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction | Day 1 and Day 10 | |
| Serum Markers of Myocyte Damage | Myocyte Damage is represented by Creatine phosphokinase (CPK). CPK is measured in U/L, as scalar measure of the enzyme activity. CPK was measured for clinical indications laboratory. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart D Katz, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19958860 | Result | Tang YD, Hasan F, Giordano FJ, Pfau S, Rinder HM, Katz SD. Effects of recombinant human erythropoietin on platelet activation in acute myocardial infarction: results of a double-blind, placebo-controlled, randomized trial. Am Heart J. 2009 Dec;158(6):941-7. doi: 10.1016/j.ahj.2009.06.032. |
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| ID | Title | Description |
|---|---|---|
| FG000 | rHuEPO | recombinant human erythropoietin 200 U/kg IV daily for 3 days |
| FG001 | Placebo | Normal saline volume to match active treatment IV daily for 3 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | rHuEPO | recombinant human erythropoietin 200 U/kg IV daily for 3 days |
| BG001 | Placebo | Normal saline volume to match active treatment IV daily for 3 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bleeding Time | An integrated measure of in vivo platelet function and tissue hemostasis. | ITT | Posted | Median | Inter-Quartile Range | seconds | Change from Day 3 to Day 10 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rHuEPO | recombinant human erythropoietin 200 U/kg IV daily for 3 days | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stuart Katz, MD | New York University School of Medicine | 212-263-3946 | stuart.katz@nyumc.org |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| Placebo | Drug | Normal saline to match active drug (rHuEpo) |
|
| Baseline |
| Circulating Endothelial Progenitor Cells | Day 3 and Day 10 |
| Serum Markers of Apoptosis | Apoptosis is represented by Fas ligand (FasL or CD95L). FasL (CD95L) is measured in pg/mL. | Day 1 and Day 10 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Primary | Platelet Function Assay Closure Time | ITT | Posted | Median | Inter-Quartile Range | seconds | Change from Day 3 to Day 10 |
|
|
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| Secondary | Left Ventricular Ejection Fraction | These data were not collected due to lack of funds. | Posted | Day 1 and Day 10 |
|
|
| Secondary | Serum Markers of Myocyte Damage | Myocyte Damage is represented by Creatine phosphokinase (CPK). CPK is measured in U/L, as scalar measure of the enzyme activity. CPK was measured for clinical indications laboratory. | ITT | Posted | Median | Inter-Quartile Range | U/L | Baseline |
|
|
|
| Secondary | Circulating Endothelial Progenitor Cells | Endothelial progenitor cells could not be isolated and are therefore not reported. | Posted | Day 3 and Day 10 |
|
|
| Secondary | Serum Markers of Apoptosis | Apoptosis is represented by Fas ligand (FasL or CD95L). FasL (CD95L) is measured in pg/mL. | ITT | Posted | Mean | Standard Deviation | pg/mL | Day 1 and Day 10 |
|
|
|
| 29 |
| 1 |
| 29 |
| 0 |
| 29 |
| EG001 | Placebo | Normal saline volume to match active treatment IV daily for 3 days | 0 | 15 | 1 | 15 | 0 | 15 |
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |