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Myocardial InfarctionPhase 3REVIVAL-3NCT00390832

Efficacy Study of Erythropoietin After Revascularization in Myocardial Infarction (REVIVAL-3)

A Phase 3 study testing Erythropoietin in people with Myocardial Infarction and Angioplasty, Transluminal, Percutaneous Coronary, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether erythropoietin is superior to placebo with respect to left ventricular ejection fraction in patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Erythropoietin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
138 participants
Where
2 sitesGermany
Study dates
Dec 2006to Mar 2009
Phase
Phase 3
Are there results?
None posted in the registry

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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with ST-Segment elevation myocardial infarction <24 h from pain onset
  • Successful primary PCI and left ventricular ejection fraction <50%
  • Informed, written consent
  • In women with childbearing potential a pregnancy test is mandatory

Who cannot join

  • Age < 18 and > 80 years
  • Cardiogenic shock
  • pericarditis
  • thrombolysis for the index infarction
  • malignancies/other comorbid conditions with life expectancy < 1 year
  • previous myocardial infarction
Show all 21Show fewer
  • planned staged PCI or prior PCI within 30 days from index procedure
  • uncontrolled hypertension >160/100mmHg unresponsive to therapy
  • epilepsy
  • active bleeding; bleeding diathesis; history of gastrointestinal or genitourinary bleeding, recent trauma or major surgery < 1 month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection; patient's refusal to blood transfusion
  • hematologic disorders such as essential thrombocytosis, megakaryoblastic leukemia, polycythemia vera
  • relevant hematologic deviations: hemoglobin < 100 g/l or hemoglobin > 160 g/l platelet count < 100 x 10^9 cells/l or platelet count > 600 x 10^9 cells/l
  • any contraindication to magnetic resonance imaging: electronically, magnetically and mechanically activated implants such as cardiac pacemakers, automatic cardioverter defibrillators, joint prostheses, surgical/vascular clips/ hearing aids, neurostimulators, infusion pumps etc metallic splinters in the eye ferromagnetic haemostatic clips in the central nervous system cochlear implants lead wires or similar wires prosthetic heart valves, if dehiscence is suspected non-ferromagnetic stapedial implants, hemostatic clips
  • glomerular filtration rate < 30 ml/min or serum creatinine > 30 mg/l or dependence on renal dialysis
  • chronic liver disease with GOT > 5-fold over the normal range
  • allergy to erythropoietin/true anaphylaxis after prior exposure to contrast media
  • phenylketonuria
  • previous enrollment in this trial
  • women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding
  • patient's inability to fully cooperate with the study protocol
  • other contraindication according to the summary of product characteristics of recombinant human erythropoietin beta (NeoRecormon®)

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Deutsches Herzzentrum Muenchen

    Munich, 80636

  • 1. Medizinische Klinik, Klinikum rechts der Isar

    Munich, 81675

Other trials in Germany

About this study

Official title: Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Erythropoietin in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention (REVIVAL-3)

The purpose of this study is to determine whether erythropoietin is superior to placebo with respect to left ventricular ejection fraction in patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention.

Read the detailed description

Erythropoietin has lately been shown to exert others than merely hematopoietic functions. Due to attenuation of cell apoptosis and necrosis and/or enhancing neovascularisation, erythropoietin could be protective after myocardial ischemia and reperfusion and lead to infarct size reduction and improvement in left ventricular function. In a controlled clinical trial, short-term administration of erythropoietin in patients with ischemic stroke was associated with a significantly better functional recovery, with a lower level of circulating damage markers and a strong trend to smaller infarct sizes measured by magnetic resonance imaging. While leaving hematocrit and platelet counts unchanged, short-term administration of erythropoietin was shown to be safe and very well tolerated (no side effects reported or observed). The protective effects of short-term erythropoietin in acute ischemic brain damage are further evaluated in an ongoing multi-center trial in Germany. Considering the preclinical and clinical data erythropoietin is an attractive candidate to be evaluated in patients with acute myocardial infarction. In a pilot trial enrolling 22 patients with acute myocardial infarction short-term administration of erythropoietin was shown to be safe and to significantly increase the level of endothelial progenitor cells after percutaneous coronary intervention. However, the very small population did not allow evaluating the benefit in left ventricular function or clinical outcomes.

The aim of the REVIVAL-3 study is to investigate whether there is additional benefit of short-term administration of erythropoietin in patients with acute myocardial infarction after successful primary percutaneous coronary intervention (PCI) in terms of left ventricular ejection fraction.

Being tested
Erythropoietin, Placebo
Keywords
STEMI
Medical subject headings
Myocardial Infarction, ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErythropoietinDrug

    Also called NeoRecormon

    33.333 IU of recombinant human erythropoietin beta are given at 3 time points (immediately, 24 hours and 48 hours after percutaneous coronary intervention) providing a cumulative dose of 100.000 IU

  • PlaceboOther

    Also called 0.9% NaCl

    Patients will receive placebo immediately, 24 hours and 48 hours after percutaneous coronary intervention.

Study groups in NCT00390832
Study groupRoleWhat they receive
AActive comparatorrecombinant human erythropoietin beta
Receives: Drug: Erythropoietin
BPlacebo comparator0.9% NaCl solution
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Left ventricular ejection fraction measured by magnetic resonance imaging

    Measured: 4-6 months

Secondary outcomes (2)

  1. Changes in left ventricular ejection fraction and infarct size

    Measured: over 6 months

  2. Death, recurrent myocardial infarction, IRA-revascularization and stroke

    Measured: 30 days, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionMar 2009
  4. Study completionMar 2009

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00390832
Sponsor's protocol ID
GE IDE No. I01106
Acronym
REVIVAL-3
Status last verified
Mar 2009
First submitted
19 Oct 2006
Last updated
17 Dec 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Kastrati A, Mehilli J, Dirschinger J, Schricke U, Neverve J, Pache J, Martinoff S, Neumann FJ, Nekolla S, Blasini R, Seyfarth M, Schwaiger M, Schomig A; Stent versus Thrombolysis for Occluded Coronary Arteries in Patients With Acute Myocardial Infarction (STOPAMI-2) Study. Myocardial salvage after coronary stenting plus abciximab versus fibrinolysis plus abciximab in patients with acute myocardial infarction: a randomised trial. Lancet. 2002 Mar 16;359(9310):920-5. doi: 10.1016/S0140-6736(02)08022-4.

    PubMed 11918909

  • Zohlnhofer D, Hausleiter J, Kastrati A, Mehilli J, Goos C, Schuhlen H, Pache J, Pogatsa-Murray G, Heemann U, Dirschinger J, Schomig A. A randomized, double-blind, placebo-controlled trial on restenosis prevention by the receptor tyrosine kinase inhibitor imatinib. J Am Coll Cardiol. 2005 Dec 6;46(11):1999-2003. doi: 10.1016/j.jacc.2005.07.060. Epub 2005 Nov 4.

    PubMed 16325031

  • Pache J, Kastrati A, Mehilli J, Bollwein H, Ndrepepa G, Schuhlen H, Martinoff S, Seyfarth M, Nekolla S, Dirschinger J, Schwaiger M, Schomig A. A randomized evaluation of the effects of glucose-insulin-potassium infusion on myocardial salvage in patients with acute myocardial infarction treated with reperfusion therapy. Am Heart J. 2004 Jul;148(1):e3. doi: 10.1016/j.ahj.2004.01.019.

    PubMed 15215812

  • Sadamoto Y, Igase K, Sakanaka M, Sato K, Otsuka H, Sakaki S, Masuda S, Sasaki R. Erythropoietin prevents place navigation disability and cortical infarction in rats with permanent occlusion of the middle cerebral artery. Biochem Biophys Res Commun. 1998 Dec 9;253(1):26-32. doi: 10.1006/bbrc.1998.9748.

    PubMed 9875214

  • Ehrenreich H, Timner W, Siren AL. A novel role for an established player: anemia drug erythropoietin for the treatment of cerebral hypoxia/ischemia. Transfus Apher Sci. 2004 Aug;31(1):39-44. doi: 10.1016/j.transci.2004.05.001.

    PubMed 15294194

  • Ehrenreich H, Hasselblatt M, Dembowski C, Cepek L, Lewczuk P, Stiefel M, Rustenbeck HH, Breiter N, Jacob S, Knerlich F, Bohn M, Poser W, Ruther E, Kochen M, Gefeller O, Gleiter C, Wessel TC, De Ryck M, Itri L, Prange H, Cerami A, Brines M, Siren AL. Erythropoietin therapy for acute stroke is both safe and beneficial. Mol Med. 2002 Aug;8(8):495-505.

    PubMed 12435860

  • Ott I, Schulz S, Mehilli J, Fichtner S, Hadamitzky M, Hoppe K, Ibrahim T, Martinoff S, Massberg S, Laugwitz KL, Dirschinger J, Schwaiger M, Kastrati A, Schmig A; REVIVAL-3 Study Investigators. Erythropoietin in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomized, double-blind trial. Circ Cardiovasc Interv. 2010 Oct;3(5):408-13. doi: 10.1161/CIRCINTERVENTIONS.109.904425. Epub 2010 Aug 24.

    PubMed 20736448

  • Steppich B, Groha P, Ibrahim T, Schunkert H, Laugwitz KL, Hadamitzky M, Kastrati A, Ott I; Regeneration of Vital Myocardium in ST-Segment Elevation Myocardial Infarction by Erythropoietin (REVIVAL-3) Study Investigators. Effect of Erythropoietin in patients with acute myocardial infarction: five-year results of the REVIVAL-3 trial. BMC Cardiovasc Disord. 2017 Jan 21;17(1):38. doi: 10.1186/s12872-016-0464-3.

    PubMed 28109258

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erythropoietin in people with Myocardial Infarction and Angioplasty, Transluminal, Percutaneous Coronary, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.

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 21 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 17 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Left ventricular ejection fraction measured by magnetic resonance imaging (time frame: 4-6 months). 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 NCT00390832, which also lists 8 linked publications.

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 17 Dec 2010.

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