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| Name | Class |
|---|---|
| Technical University of Munich | OTHER |
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The objective of this international, multicenter, randomized study is to assess whether coronary artery stenting is associated with a reduced infarct size in patients with AMI presenting between 12 and 48 hours after onset of symptoms compared to medical treatment alone
Between 8.5% and 40% of patients with acute myocardial infarction present late after symptom onset, no longer being eligible for thrombolysis.Despite efforts to reduce time to presentation, recent studies have demonstrated that time-to-arrival has not changed.The lack of efficacy of thrombolysis in patients with acute MI presenting > 12 hours after symptom onset may be a reason why current guidelines oppose reperfusion therapy in this setting.Several findings suggest, however,that reperfusion therapy may be beneficial even among these patients. First, recent studies have shown that viable salvageable myocardium exists even after >12 hours of severe ischemia. Second, previous studies have not only demonstrated that PCI is better than thrombolysis in patients with acute MI,but also that the time window of efficacy for PCI may be wider than that for thrombolysis.Third, observational studies suggest that PCI is effective even when performed after 12 hours from symptom onset in patients with acute MI. The goal of our trial was to assess whether an invasive strategy based on PCI with stenting is associated with reduction of infarct size in patients with acute STEMI presenting > 12 hours after symptom onset compared with a conventional conservative treatment strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Interventional treatment group - Patients assigned to PCI will receive the loading dose of clopidogrel, aspirin plus a bolus of heparin and be transferred immediately for interventional treatment. They will receive abciximab as a bolus followed by a continuous infusion of for 12 hours. |
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| B | Active Comparator | Conservative treatment group - Patients assigned to this group will receive the usual therapy in the intensive care unit of the admitting hospital according to local standards. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interventional treatment group | Other | Patients assigned to PCI will receive the loading dose of clopidogrel (300 mg), 500 mg aspirin plus a bolus of 70 U/kg heparin i.v. and be transferred immediately for interventional treatment. They will receive abciximab as a bolus of 0.25 mg/Kg of body weight followed by a continuous infusion of 0.125 µg/Kg/minute (up to a maximal dose of 10 µg/minute) for 12 hours. All patients will undergo coronary angiography and left ventriculography in the conventional way. During the procedure patients will receive the weight-adjusted heparin doses (70 U/ kg). Post-procedural antithrombotic therapy will consist of clopidogrel in a daily dose of 75 mg for at least 4 weeks (6 months recommended) and aspirin, 100 mg to 350 mg daily, indefinitely. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of the study is the infarct size calculated as the final perfusion defect (% of left ventricle) at the scintigraphic study | 5-10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoint of the study is the composite of all-cause death, recurrent MI, or stroke within 30 days after randomization. | 30 days |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Schoemig, MD | Deutsches Herzzentrum Muenchen | Study Chair |
| Adnan Kastrati, MD | Deutsches Herzzentrum Muenchen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landeskrankenhaus Feldkirch | Feldkirch | Austria | ||||
| Staedtisches Krankenhaus Bad Reichenhall |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15956631 | Result | Schomig A, Mehilli J, Antoniucci D, Ndrepepa G, Markwardt C, Di Pede F, Nekolla SG, Schlotterbeck K, Schuhlen H, Pache J, Seyfarth M, Martinoff S, Benzer W, Schmitt C, Dirschinger J, Schwaiger M, Kastrati A; Beyond 12 hours Reperfusion AlternatiVe Evaluation (BRAVE-2) Trial Investigators. Mechanical reperfusion in patients with acute myocardial infarction presenting more than 12 hours from symptom onset: a randomized controlled trial. JAMA. 2005 Jun 15;293(23):2865-72. doi: 10.1001/jama.293.23.2865. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Conservative treatment group | Other | Patients assigned to this group will receive the usual therapy in the intensive care unit of the admitting hospital according to local standards. Per protocol, all patients in this arm will receive a loading dose of clopidogrel (300 mg) followed by 75 mg/day for at least 4 weeks (6 months recommended) after randomization and aspirin, indefinitely. Recommended additional regimen will include heparin, ß-blockers, ACE inhibitors and statins |
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| Bad Reichenhall |
| Germany |
| Kreiskrankenhaus Erding/Dorfen | Erding | 85435 | Germany |
| Kreiskrankenhaus Freilassing | Freilassing | Germany |
| Kreisklinik Fuerstenfeldbruck | Fürstenfeldbruck | Germany |
| Klinikum Garmisch-Partenkirchen | Garmisch-Partenkirchen | 82467 | Germany |
| Deutsches Herzzentrum Muenchen | Munich | 80636 | Germany |
| 1st Medizinische Klinik, Klinikum rechts der Isar | Munich | 81675 | Germany |
| Krankenhaus Vinzentinum Ruhpolding | Ruhpolding | Germany |
| Krankenhaus Schongau | Schongau | Germany |
| Klinikum Traunstein | Traunstein | 83278 | Germany |
| Kreisklinik Trostberg | Trostberg an der Alz | Germany |
| Azienda Ospedaliera Careggi | Florence | Italy |
| Ospedale, "Umberto I" | Mestre | Italy |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |