Myocardial InfarctionPhase 3MISTRALNCT00638638
Myocardial Infarction With ST-Elevation
A Phase 3 study testing Abciximab in people with Myocardial Infarction, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Mechanical recanalization of the culprit artery in acute myocardial infarction using stents provides in 2003, TIMI 3 flow restoration in more than 90% of patients. However, the prognosis of this condition remains poor, to a large degree because of microcirculatory dysfunction that is observed, in near than 20 to 40 %… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Abciximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 292 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2005to Jan 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age eligible for randomization in the MICU
- Infarct within 6 hours from symptoms onset
- Continuous typical chest pain symptoms symptoms for more than 20 min. and-ST segment elevation of more than 2 mm in more than two leads (peripheral or precordial)
- Signed informed consent form
Who cannot join
- Ventricular conduction anomalies masking signs of ischemia (left or right bundle branch block without evidence of additional elevation), electrical left ventricular hypertrophy
- Known hypersensitivity to Abciximab or to any component of the product or to murine monoclonal antibodies.- Hemorrhagic diathesis, internal hemorrhage
- Hemorrhagic stroke within 2 years
- Ischemic stroke within the last 3 months- Intra-cranial neoplasm, intracranial malformation or arteria
- venous aneurysm
- Recent intracranial or intraspinal surgery or trauma (within two months)
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- Recent within (2 months) major surgery- Known peptic ulcer or upper gastrointestinal bleeding within the previous 6 month
- Known coagulation anomaly
- Oral anti-coagulant or low molecular weight heparin treatment- Ongoing thrombolytic treatment
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Cardiologie - Hôpital de Hautepierre - 1, Avenue Molière
Strasbourg, 67 098
About this study
Official title: Myocardial Infarction With ST-elevation Treated by Primary Percutaneous Intervention Facilitated by Early Reopro Administration in Alsace.
Mechanical recanalization of the culprit artery in acute myocardial infarction using stents provides in 2003, TIMI 3 flow restoration in more than 90% of patients. However, the prognosis of this condition remains poor, to a large degree because of microcirculatory dysfunction that is observed, in near than 20 to 40 % of patients, during or following primary percutaneous intervention. The lack of ST-segment elevation resolution after angioplasty with stenting is a marker of microcirculatory dysfunction and is associated with a poor prognosis. Routine administration with primary stenting of the platelet glycoprotein IIb/IIIa inhibitor Abciximab in acute myocardial infarction is still a matter of debate with conflicting results emerging from two major clinical studies ADMIRAL and CADILLAC. However, evidences are in favour of a benefit of this treatment especially when administrated early (in a pre-hospital manner) before percutaneous coronary intervention.Our primary purpose is to investigate the benefit of an early (i.e. pre-hospital) vs. a conventional (i.e. per-angiography) administration of Abciximab on ST-segment elevation regression at one hour after primary percutaneous angioplasty.
- Conditions
- Myocardial Infarction
- Being tested
- Abciximab, Abciximab placebo
- Keywords
- Myocardial infarction, Angioplasty, Coronary stenting, Abciximab, Myocardial reperfusion, Microcirculation, EKG, ST elevation myocardial infarction within 6 h of symptom onset
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbciximabDrug
Also called 1: Experimental, 2: Experimental
- Abciximab: 0.25 mg/Kg bolus
- Abciximab placebo bolus
- Abciximab infusion 10 µg/Kg/min
Abciximab placeboDrug
Also called 1: Experimental, 2: Experimental
- Abciximab placebo Bolus
- Abciximab: 0.25 mg/Kg bolus
- Abciximab infusion 10 µg/Kg/min
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | * Early Abciximab bolus during prehospital transportation in ambulance 0.25 mg/Kg iv with Heparin 40 UI/kg bolus.
* Abciximab placebo bolus and Abciximab infusion 10 µg/Kg/min after coronary angiography and before angioplasty. Receives: Drug: Abciximab; Drug: Abciximab placebo |
| 2 | Experimental | * Abciximab placebo bolus during prehospital transportation in ambulance with Heparin 40 UI/kg bolus.
* Abciximab 0.25 mg/Kg bolus after coronary angiography and before angioplasty followed by Abciximab infusion 10 µg/Kg/min. Receives: Drug: Abciximab; Drug: Abciximab placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ST segment regression 1 hour after angioplasty
Measured: 1 hour after angioplasty
Secondary outcomes (1)
Major cardiac events at 1 and 6 month
Measured: 1 and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startJan 2005
- Primary completionAug 2009 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Investigators
- Patrick OHLMANN, MD, PhD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638638
- Sponsor's protocol ID
- 3233
- Acronym
- MISTRAL
- Status last verified
- Sep 2009
- First submitted
- 28 Feb 2008
- Last updated
- 17 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ohlmann P, Reydel P, Jacquemin L, Adnet F, Wolf O, Bartier JC, Weiss A, Lapostolle F, Gaultier C, Salengro E, Benamer H, Guyon P, Chevalier B, Catan S, Ecollan P, Chouihed T, Angioi M, Zupan M, Bronner F, Bareiss P, Steg G, Montalescot G, Monassier JP, Morel O. Prehospital abciximab in ST-segment elevation myocardial infarction: results of the randomized, double-blind MISTRAL study. Circ Cardiovasc Interv. 2012 Feb 1;5(1):69-76, S1. doi: 10.1161/CIRCINTERVENTIONS.111.961425. Epub 2012 Feb 7.
PubMed 22319064
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Infarction With ST-elevation Treated by Primary Percutaneous Intervention Facilitated by Early Reopro Administration in Alsace.
- ClinicalTrials.gov ID
- NCT00638638
- Acronym / sponsor ID
- MISTRAL / 3233
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial infarction, Angioplasty, Coronary stenting, Abciximab, Myocardial reperfusion, Microcirculation, EKG, ST elevation myocardial infarction within 6 h of symptom onset
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jan 2005
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 19 Mar 2008 (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.
Mechanical recanalization of the culprit artery in acute myocardial infarction using stents provides in 2003, TIMI 3 flow restoration in more than 90% of patients. However, the prognosis of this condition remains poor, to a large degree because of microcirculatory dysfunction that is observed, in near than 20 to 40 % of patients, during or following primary percutaneous intervention. The lack of ST-segment elevation resolution after angioplasty with stenting is a marker of microcirculatory dysfunction and is associated with a poor prognosis. Routine administration with primary stenting of the platelet glycoprotein IIb/IIIa inhibitor Abciximab in acute myocardial infarction is still a matter of debate with conflicting results emerging from two major clinical studies ADMIRAL and CADILLAC. However, evidences are in favour of a benefit of this treatment especially when administrated early (in a pre-hospital manner) before percutaneous coronary intervention.Our primary purpose is to investigate the benefit of an early (i.e. pre-hospital) vs. a conventional (i.e. per-angiography) administration of Abciximab on ST-segment elevation regression at one hour after primary percutaneous angioplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Abciximab, Drug: Abciximab placebo* Early Abciximab bolus during prehospital transportation in ambulance 0.25 mg/Kg iv with Heparin 40 UI/kg bolus. * Abciximab placebo bolus and Abciximab infusion 10 µg/Kg/min after coronary angiography and before angioplasty. |
| 2 | Experimental | Drug: Abciximab, Drug: Abciximab placebo* Abciximab placebo bolus during prehospital transportation in ambulance with Heparin 40 UI/kg bolus. * Abciximab 0.25 mg/Kg bolus after coronary angiography and before angioplasty followed by Abciximab infusion 10 µg/Kg/min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years of age eligible for randomization in the MICU
- Infarct within 6 hours from symptoms onset
- Continuous typical chest pain symptoms symptoms for more than 20 min. and-ST segment elevation of more than 2 mm in more than two leads (peripheral or precordial)
- Signed informed consent form
Key exclusion criteria (9 listed)
- Ventricular conduction anomalies masking signs of ischemia (left or right bundle branch block without evidence of additional elevation), electrical left ventricular hypertrophy
- Known hypersensitivity to Abciximab or to any component of the product or to murine monoclonal antibodies.- Hemorrhagic diathesis, internal hemorrhage
- Hemorrhagic stroke within 2 years
- Ischemic stroke within the last 3 months- Intra-cranial neoplasm, intracranial malformation or arteria
- venous aneurysm
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 |
|---|---|---|
| AbciximabAlso: 1: Experimental, 2: Experimental* Abciximab: 0.25 mg/Kg bolus * Abciximab placebo bolus * Abciximab infusion 10 µg/Kg/min | Drug | 1, 2 |
| Abciximab placeboAlso: 1: Experimental, 2: Experimental* Abciximab placebo Bolus * Abciximab: 0.25 mg/Kg bolus * Abciximab infusion 10 µg/Kg/min | Drug | 1, 2 |
Primary outcome
ST segment regression 1 hour after angioplasty
Time frame: 1 hour after angioplasty
1 secondary outcome
Major cardiac events at 1 and 6 month
Time frame: 1 and 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2009.
- Derived from this study: PubMed 22319064Ohlmann P, Reydel P, Jacquemin L, Adnet F, Wolf O, Bartier JC, Weiss A, Lapostolle F, Gaultier C, Salengro E, Benamer H, Guyon P, Chevalier B, Catan S, Ecollan P, Chouihed T, Angioi M, Zupan M, Bronner F, Bareiss P, Steg G, Montalescot G, Monassier JP, Morel O. Prehospital abciximab in ST-segment elevation myocardial infarction: results of the randomized, double-blind MISTRAL study. Circ Cardiovasc Interv. 2012 Feb 1;5(1):69-76, S1. doi: 10.1161/CIRCINTERVENTIONS.111.961425. Epub 2012 Feb 7.
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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.
Patrick OHLMANN, MD, PhD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abciximab in people with Myocardial Infarction, run by University Hospital, Strasbourg, France at 1 site in France.
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 9 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: status not confirmed, as of the sponsor's last update on 17 Sep 2009. 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 France. 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 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?
Results are not available in the source record.
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?
ST segment regression 1 hour after angioplasty (time frame: 1 hour after angioplasty). 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 NCT00638638, 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 17 Sep 2009.