Acute Myocardial InfarctionPhase 2BEATSTEMIPiNCT01093820
Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction
A Phase 2 study testing methoxy-polyethyleneglycol epoetin beta in people with Acute Myocardial Infarction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Hypothesis: Based on available pharmacokinetic data from healthy volunteers we hypothesize that the administration of a cumulative dose of 210μg of the continuous erythropoietin receptor activator, Mircera® (Roche), during 3 months post percutaneous coronary intervention (PCI) does not result in hemoglobin (Hb) levels… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- methoxy-polyethyleneglycol epoetin beta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2010to Oct 2010
- Phase
- Phase 2
- 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 (age 18 - 80 years) with acute STEMI undergoing PCI
- Main Exclusion Criteria:
- Hemoglobin levels >15g/dL
- history of a myeloproliferative syndrome
- thrombolysis for index infarction
- anticipated additional revascularization within 3 months
- cardiogenic shock
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Documentation of Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction (BEAT-STEMI Pilot)
Hypothesis:
Based on available pharmacokinetic data from healthy volunteers we hypothesize that the administration of a cumulative dose of 210μg of the continuous erythropoietin receptor activator, Mircera® (Roche), during 3 months post percutaneous coronary intervention (PCI) does not result in hemoglobin (Hb) levels >15 g/dl in patients with ST-segment elevation myocardial infarction (STEMI)
Design:
Prospective, open label single center pilot study
Read the detailed description
This pilot trial will include 8 patients. The inclusion of 8 patients will allow to perform representative statistics of expected Hb kinetics in response to Mircera®.
- Conditions
- Acute Myocardial Infarction
- Being tested
- methoxy-polyethyleneglycol epoetin beta
- Keywords
- acute myocardial infarction, continuous erythropoetin receptor activator, Mircera, hemoglobin kinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methoxy-polyethyleneglycol epoetin betaDrug
Also called Mircera
Mircera® 150μg i.v., before / during reperfusion of the infarct related coronary artery followed by Mircera® 30μg s.c. at 1 and 2 months post-MI
| Study group | Role | What they receive |
|---|---|---|
| Epopoetinum beta | Experimental | Mircera® 150μg i.v., before / during reperfusion of the infarct related coronary artery followed by Mircera® 30μg s.c. at 1 and 2 months post-MI Receives: Drug: methoxy-polyethyleneglycol epoetin beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months
measurement of Hb at baseline and month 1, 2 and 3
Measured: three months
Secondary outcomes (7)
Maximal change in Hb within 3 months relative to baseline
measurement of Hb at baseline and month 1, 2 and 3
Measured: three months
Relative change in Hb from baseline to 1 months
measurement of Hb at baseline and month 1
Measured: first month
Maximal change in Hematocrit (Hk) within 3 months relative to baseline
measurement of Hk at baseline and month 1, 2 and 3
Measured: three months
change in platelet count within 3 months relative to baseline
measurement of platelet count at baseline and month 1, 2 and 3
Measured: three months
Safety endpoints including all cause mortality,myocardial infarction,stroke,hospitalization,life threatening arrhythmias,thromboembolic events,stent thrombosis,poorly controlled hypertension despite therapy,seizures
follow-up at month 1, 2 and 3
Measured: three months
Relative change in Hb from 1 to 2 months
measurement of Hb at month 1 and 2
Measured: second month
Relative change in Hb from 2 to 3 months
measurement of Hb at month 2 and 3
Measured: third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Pfisterer, Prof. MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093820
- Sponsor's protocol ID
- 2010 DR 2029
- Acronym
- BEATSTEMIPi
- Status last verified
- Feb 2012
- First submitted
- 16 Mar 2010
- Last updated
- 29 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Documentation of Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction (BEAT-STEMI Pilot)
- ClinicalTrials.gov ID
- NCT01093820
- Acronym / sponsor ID
- BEATSTEMIPi / 2010 DR 2029
- Conditions
- Acute Myocardial Infarction
- Keywords
- acute myocardial infarction, continuous erythropoetin receptor activator, Mircera, hemoglobin kinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 26 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis:
Based on available pharmacokinetic data from healthy volunteers we hypothesize that the administration of a cumulative dose of 210μg of the continuous erythropoietin receptor activator, Mircera® (Roche), during 3 months post percutaneous coronary intervention (PCI) does not result in hemoglobin (Hb) levels >15 g/dl in patients with ST-segment elevation myocardial infarction (STEMI)
Design:
Prospective, open label single center pilot study
Detailed description
This pilot trial will include 8 patients. The inclusion of 8 patients will allow to perform representative statistics of expected Hb kinetics in response to Mircera®.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epopoetinum beta | Experimental | Drug: methoxy-polyethyleneglycol epoetin betaMircera® 150μg i.v., before / during reperfusion of the infarct related coronary artery followed by Mircera® 30μg s.c. at 1 and 2 months post-MI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients (age 18 - 80 years) with acute STEMI undergoing PCI
- Hemoglobin levels >15g/dL
- history of a myeloproliferative syndrome
- thrombolysis for index infarction
- anticipated additional revascularization within 3 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| methoxy-polyethyleneglycol epoetin betaAlso: MirceraMircera® 150μg i.v., before / during reperfusion of the infarct related coronary artery followed by Mircera® 30μg s.c. at 1 and 2 months post-MI | Drug | Epopoetinum beta |
Primary outcome
Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months
Time frame: three months
measurement of Hb at baseline and month 1, 2 and 3
7 secondary outcomes
Maximal change in Hb within 3 months relative to baseline
Time frame: three months
Relative change in Hb from baseline to 1 months
Time frame: first month
Maximal change in Hematocrit (Hk) within 3 months relative to baseline
Time frame: three months
change in platelet count within 3 months relative to baseline
Time frame: three months
Safety endpoints including all cause mortality,myocardial infarction,stroke,hospitalization,life threatening arrhythmias,thromboembolic events,stent thrombosis,poorly controlled hypertension despite therapy,seizures
Time frame: three months
Relative change in Hb from 1 to 2 months
Time frame: second month
Relative change in Hb from 2 to 3 months
Time frame: third month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2012.
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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.
Matthias Pfisterer, Prof. MD principal investigator
University Hospital, Basel, Switzerland
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 methoxy-polyethyleneglycol epoetin beta in people with Acute Myocardial Infarction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 7 inclusion and 0 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 29 Feb 2012. 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 Switzerland. 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. 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?
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?
Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Feb 2012.