Myocardial InfarctionPhase 2ERASE-MINCT00546260
Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI
A Phase 2 study testing PRT060128 Potassium in people with Myocardial Infarction, run by Alexion Pharmaceuticals, Inc. at 31 sites in 2 countries.
Trial summary
Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- PRT060128 Potassium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 31 sitesin 2 countries
- Study dates
- Nov 2007to Jul 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent ST elevation ≥ 1mm (≥ 0.1mV) in two contiguous limb leads OR ≥ 2 mm (≥ 0.2mV) in two contiguous precordial leads, AND chest pain ≥ 20 minutes with onset within 6 hours of hospital presentation.
Who cannot join
- Cardiogenic shock (systolic blood pressure < 90 mm Hg requiring vasopressor or hemodynamic support)
- Uncontrolled hypertension defined as any measured systolic blood pressure (SBP) > 180 mm Hg or diastolic blood pressure (DBP) ≥ 110 mm Hg after the time -- History or symptoms of a congenital or acquired bleeding disorder or vascular malformation.
- Recent gastrointestinal bleeding within the last 30 days.
- Known thrombocytopenia (platelet count < 100,000/mm3).
- Any treatment with a fibrinolytic agent within the last 7 days.
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
Canada18 sites
Foothills Hospital
Calgary, Alberta, T2N2T9
Royal Alexandria Hospital
Edmonton, Alberta, T5H3V7
University of Alberta Hospital
Edmonton, Alberta, T6G2B7
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H3A7
Hamilton Health Sciences
Hamilton, Ontario, L8L2X2
London Health Sciences
London, Ontario, N6A5A5
Trillium Health Centre - Mississaugua
Mississauga, Ontario, L5B2P7
Montreal Heart Institute
Montreal, Quebec, H1T1C8
Centre Hospitalier Universitaire de Montreal - Hotel Dieu
Montreal, Quebec, H2W1T8
Hospital du Sacre Coeur
Montreal, Quebec, H4N1C5
Soutlake Regional Health Centre
Newmarket, Ontario, L3Y2R2
Regina General Hospital
Regina, Saskatchewan, S4P0W5
Atlantic Health Services
Saint John, New Brunswick, E2L4L2
General Hospital - Heath Sciences Centre
St. John's, Newfoundland and Labrador, A1B3V6
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9
St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6
Victoria Heart Institute, Royal Jubilee Hospital
Victoria, British Columbia, V8R4R2
United States13 sites
Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
Geisinger Medical Center
Danville, Pennsylvania, 17822
Iowa Heart Center
Des Moines, Iowa, 50314
Henry Ford Hospital
Detroit, Michigan, 48202
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
The Heart Center
Kingsport, Tennessee, 37660
University of Kentucky Hospital, Gill Heart Center
Lexington, Kentucky, 40536
St. Joseph Mercy - Oakland
Pontiac, Michigan, 48341
Maine Medical Center
Portland, Maine, 04102
William Beaumont Hospital
Royal Oak, Michigan, 48073
Washington Adventist Hospital
Takoma Park, Maryland, 20912
Tallahassee Memorial Medical Center
Tallahassee, Florida, 32308
William Beaumont Hospital - Troy Cardiology
Troy, Michigan, 48085
About this study
Official title: Randomized Trial to Evaluate Effect of Adjunctive Antiplatelet Therapy With Intravenous PRT060128, a Selective P2Y12-Receptor Inhibitor, Before Primary Percutaneous Intervention (PCI) in ST-Elevation Myocardial Infarction (STEMI) Patients
Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)
Read the detailed description
Patients with STEMI who are to undergo primary PCI will be randomized to an intravenous (iv) bolus of placebo vs. PRT060128 prior to angiography.
- Conditions
- Myocardial Infarction
- Being tested
- placebo, PRT060128 Potassium
- Keywords
- STEMI, ACS
- 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.
placeboDrug
administration of iv bolus prior to angiography
PRT060128 PotassiumDrug
administration of iv bolus prior to angiography
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo for each Dose cohort: 10, 20, 40, and 60 mg Receives: Drug: placebo |
| 2 | Experimental | Experimental drug for each Dose cohort: 10, 20, 40, and 60 mg Receives: Drug: PRT060128 Potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Thrombolysis in Myocardial Infarction (TIMI) Major/Minor Bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/Moderate Bleeding Through Hospital Discharge, and Intracranial Hemorrhage Through 30 Days
TIMI Major:Intracranial bleeding or a decrease in the hemoglobin concentration of 5g/dL or more, or 15% or greater decrease in hematocrit.
TIMI Minor:Hemoglobin concentration decreased by 3g/dL (but <5g/dL) or the hematocrit decreased by 10-15%.
GUSTO Severe/life threatening:Intracranial hemorrhage or bleeding that causes hemodynamic compromise requiring intervention.
GUSTO Moderate:Bleeding that requires bloodtransfusion but does not lead to hemodynamic compromise requiring intervention.
Stroke:New focal neurologic deficit that does not resolve within 24 hours.
Measured: 30 days
Secondary outcomes (2)
Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI
This measure was used to assess flow in the epicardial artery. It is the number of cine frames required for contrast to reach a standardized distal coronary landmark in the culprit vessel and was to be counted using an electronic frame counter.
Measured: Time for contrast to reach a standardized distal coronary landmark in the culprit vessel
Percentage ST-segment Resolution Prior to PCI
The relative effect of PRT060128 on ST-segment measured after PCI and expressed as a percent of ST-Segment prior to PCI. This measure was used to evaluate the dethrombotic and early reperfusion effects of PRT060128 in STEMI.
Measured: Before primary PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: Administrative reasons.
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 Alexion Pharmaceuticals, Inc.The 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew T. Roe, MD, MHS, Principal investigator, Duke Clinical Research InstituteMichael Gibson, MD, MS, Principal investigator, PERFUSE Angiographic Core Laboratory and Data Coordinating Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546260
- Sponsor's protocol ID
- 07-113
- Acronym
- ERASE-MI
- Status last verified
- Jun 2026
- First submitted
- 16 Oct 2007
- Last updated
- 24 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Berger JS, Roe MT, Gibson CM, Kilaru R, Green CL, Melton L, Blankenship JD, Metzger DC, Granger CB, Gretler DD, Grines CL, Huber K, Zeymer U, Buszman P, Harrington RA, Armstrong PW. Safety and feasibility of adjunctive antiplatelet therapy with intravenous elinogrel, a direct-acting and reversible P2Y12 ADP-receptor antagonist, before primary percutaneous intervention in patients with ST-elevation myocardial infarction: the Early Rapid ReversAl of platelet thromboSis with intravenous Elinogrel before PCI to optimize reperfusion in acute Myocardial Infarction (ERASE MI) pilot trial. Am Heart J. 2009 Dec;158(6):998-1004.e1. doi: 10.1016/j.ahj.2009.10.010.
PubMed 19958867
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Evaluate Effect of Adjunctive Antiplatelet Therapy With Intravenous PRT060128, a Selective P2Y12-Receptor Inhibitor, Before Primary Percutaneous Intervention (PCI) in ST-Elevation Myocardial Infarction (STEMI) Patients
- ClinicalTrials.gov ID
- NCT00546260
- Acronym / sponsor ID
- ERASE-MI / 07-113
- Conditions
- Myocardial Infarction
- Keywords
- STEMI, ACS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative reasons.
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 18 Oct 2007 (estimated)
- Results
- Posted 25 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)
Detailed description
Patients with STEMI who are to undergo primary PCI will be randomized to an intravenous (iv) bolus of placebo vs. PRT060128 prior to angiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placeboPlacebo for each Dose cohort: 10, 20, 40, and 60 mg |
| 2 | Experimental | Drug: PRT060128 PotassiumExperimental drug for each Dose cohort: 10, 20, 40, and 60 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persistent ST elevation ≥ 1mm (≥ 0.1mV) in two contiguous limb leads OR ≥ 2 mm (≥ 0.2mV) in two contiguous precordial leads, AND chest pain ≥ 20 minutes with onset within 6 hours of hospital presentation.
Key exclusion criteria (5 listed)
- Cardiogenic shock (systolic blood pressure < 90 mm Hg requiring vasopressor or hemodynamic support)
- Uncontrolled hypertension defined as any measured systolic blood pressure (SBP) > 180 mm Hg or diastolic blood pressure (DBP) ≥ 110 mm Hg after the time -- History or symptoms of a congenital or acquired bleeding disorder or vascular malformation.
- Recent gastrointestinal bleeding within the last 30 days.
- Known thrombocytopenia (platelet count < 100,000/mm3).
- Any treatment with a fibrinolytic agent within the last 7 days.
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 |
|---|---|---|
| placeboadministration of iv bolus prior to angiography | Drug | 1 |
| PRT060128 Potassiumadministration of iv bolus prior to angiography | Drug | 2 |
Primary outcome
Number of Patients With Thrombolysis in Myocardial Infarction (TIMI) Major/Minor Bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/Moderate Bleeding Through Hospital Discharge, and Intracranial Hemorrhage Through 30 Days
Time frame: 30 days
TIMI Major:Intracranial bleeding or a decrease in the hemoglobin concentration of 5g/dL or more, or 15% or greater decrease in hematocrit. TIMI Minor:Hemoglobin concentration decreased by 3g/dL (but <5g/dL) or the hematocrit decreased by 10-15%. GUSTO Severe/life threatening:Intracranial hemorrhage or bleeding that causes hemodynamic compromise requiring intervention. GUSTO Moderate:Bleeding that requires bloodtransfusion but does not lead to hemodynamic compromise requiring intervention. Stroke:New focal neurologic deficit that does not resolve within 24 hours.
2 secondary outcomes
Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI
Time frame: Time for contrast to reach a standardized distal coronary landmark in the culprit vessel
Percentage ST-segment Resolution Prior to PCI
Time frame: Before primary PCI
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19958867Berger JS, Roe MT, Gibson CM, Kilaru R, Green CL, Melton L, Blankenship JD, Metzger DC, Granger CB, Gretler DD, Grines CL, Huber K, Zeymer U, Buszman P, Harrington RA, Armstrong PW. Safety and feasibility of adjunctive antiplatelet therapy with intravenous elinogrel, a direct-acting and reversible P2Y12 ADP-receptor antagonist, before primary percutaneous intervention in patients with ST-elevation myocardial infarction: the Early Rapid ReversAl of platelet thromboSis with intravenous Elinogrel before PCI to optimize reperfusion in acute Myocardial Infarction (ERASE MI) pilot trial. Am Heart J. 2009 Dec;158(6):998-1004.e1. doi: 10.1016/j.ahj.2009.10.010.
- Sponsor home pageLink provided by the sponsor.
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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.
Matthew T. Roe, MD, MHS principal investigator
Duke Clinical Research Institute
Michael Gibson, MD, MS principal investigator
PERFUSE Angiographic Core Laboratory and Data Coordinating Center
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRT060128 Potassium in people with Myocardial Infarction, run by Alexion Pharmaceuticals, Inc. at 31 sites in 2 countries.
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 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Canada, 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 25 Jan 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?
Number of Patients With Thrombolysis in Myocardial Infarction (TIMI) Major/Minor Bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/Moderate Bleeding Through Hospital Discharge, and Intracranial Hemorrhage Through 30 Days (time frame: 30 days). 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 NCT00546260, 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 24 Jun 2026.