Myocardial InfarctionPhase 2NCT00367991
Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction
A Phase 2 study testing Recombinant human erythropoietin alfa (drug) in people with Myocardial Infarction, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Recombinant human erythropoietin alfa (drug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Mar 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-75 years
- Clinical evidence of acute myocardial infarction (MI) with total or sub-total occlusion on angiogram
- Status post percutaneous revascularization procedure for acute MI with TIMI 3 flow
- Ongoing clinically-indicated treatment with aspirin, thienopyridines
Who cannot join
- Hemodynamic instability/shock or severe congestive heart failure
- Time from onset of chest pain to revascularization procedure > 16 hours
- Use of intravenous thrombolytic agents for treatment of MI
- Known need for additional revascularization procedures
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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
- Conditions
- Myocardial Infarction
- Being tested
- Recombinant human erythropoietin alfa (drug), Placebo
- Keywords
- Platelet function tests, Erythropoietin, Myocardial infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDrug
Normal saline to match active drug (rHuEpo)
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | recombinant human erythropoietin 200 U/kg IV daily for 3 days Receives: Drug: Recombinant human erythropoietin alfa (drug) |
| B | Placebo comparator | Normal saline volume to match active treatment IV daily for 3 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding Time
An integrated measure of in vivo platelet function and tissue hemostasis.
Measured: Change from Day 3 to Day 10
Platelet Function Assay Closure Time
Measured: Change from Day 3 to Day 10
Secondary outcomes (4)
Left Ventricular Ejection Fraction
Measured: 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.
Measured: Baseline
Circulating Endothelial Progenitor Cells
Measured: 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.
Measured: Day 1 and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2006 (estimated)
- Study startNov 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Stuart D Katz, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367991
- Sponsor's protocol ID
- 0506000140
- Other IDs
- 0555844T
- Status last verified
- Dec 2017
- First submitted
- 23 Aug 2006
- Last updated
- 12 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19958860
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00367991
- Acronym / sponsor ID
- 0506000140
- Conditions
- Myocardial Infarction
- Keywords
- Platelet function tests, Erythropoietin, Myocardial infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Nov 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 24 Aug 2006 (estimated)
- Results
- Posted 13 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Recombinant human erythropoietin alfa (drug)recombinant human erythropoietin 200 U/kg IV daily for 3 days |
| B | Placebo comparator | Drug: PlaceboNormal saline volume to match active treatment IV daily for 3 days |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21-75 years
- Clinical evidence of acute myocardial infarction (MI) with total or sub-total occlusion on angiogram
- Status post percutaneous revascularization procedure for acute MI with TIMI 3 flow
- Ongoing clinically-indicated treatment with aspirin, thienopyridines
Key exclusion criteria (4 listed)
- Hemodynamic instability/shock or severe congestive heart failure
- Time from onset of chest pain to revascularization procedure > 16 hours
- Use of intravenous thrombolytic agents for treatment of MI
- Known need for additional revascularization procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human erythropoietin alfa (drug)200 U/kg IV daily for 3 days vs. matched volume of normal saline IV daily for 3 days | Drug | A |
| PlaceboNormal saline to match active drug (rHuEpo) | Drug | B |
Primary outcome
Bleeding Time
Time frame: Change from Day 3 to Day 10
An integrated measure of in vivo platelet function and tissue hemostasis.
Platelet Function Assay Closure Time
Time frame: Change from Day 3 to Day 10
4 secondary outcomes
Left Ventricular Ejection Fraction
Time frame: Day 1 and Day 10
Serum Markers of Myocyte Damage
Time frame: Baseline
Circulating Endothelial Progenitor Cells
Time frame: Day 3 and Day 10
Serum Markers of Apoptosis
Time frame: Day 1 and Day 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19958860Tang 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.
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart D Katz, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant human erythropoietin alfa (drug) in people with Myocardial Infarction, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding Time (time frame: Change from Day 3 to Day 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00367991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.