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

NCT00390832 | Completed Phase 3 DMC

• 1 other identifier: GE IDE No. I01106
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Myocardial Infarction; Angioplasty, Transluminal, Percutaneous Coronary

Keywords

STEMI

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction measured by magnetic resonance imaging

  4-6 months

Secondary Outcomes (2)

• Changes in left ventricular ejection fraction and infarct size

  over 6 months

• Death, recurrent myocardial infarction, IRA-revascularization and stroke

  30 days, 6 months

Study Arms (2)

A

ACTIVE COMPARATOR

recombinant human erythropoietin beta

Drug: Erythropoietin

B

PLACEBO COMPARATOR

0.9% NaCl solution

Other: Placebo

Interventions

Erythropoietin DRUG

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

Also known as: NeoRecormon

A

Placebo OTHER

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

Also known as: 0.9% NaCl

B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (2)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

1. Medizinische Klinik, Klinikum rechts der Isar

Munich, 81675, Germany

Location

Related Publications (8)

• 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.

  PMID: 11918909 BACKGROUND

• 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.

  PMID: 16325031 BACKGROUND

• 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.

  PMID: 15215812 BACKGROUND

• 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.

  PMID: 9875214 BACKGROUND

• 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.

  PMID: 15294194 BACKGROUND

• 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.

  PMID: 12435860 BACKGROUND

• 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.

  PMID: 20736448 RESULT

• 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.

  PMID: 28109258 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction

Interventions

Erythropoietin; epoetin beta; Saline Solution

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Albert Schomig, MD

  Deutsches Herzzentrum Muenchen

  STUDY CHAIR

• Ilka Ott, MD

  Deutsches Herzzentrum Muenchen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 19, 2006
• First Posted: October 20, 2006
• Study Start: December 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 17, 2010

Record last verified: 2009-03

Locations

DE (2)