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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00133250 |
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Date of registration:
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20/08/2005 |
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Primary sponsor: |
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Public title:
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Value of Abciximab in Patients With AMI Undergoing Primary PCI After Clopidogrel Pretreatment (BRAVE 3)
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Scientific title:
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Value of Abciximab in Patients With AMI Undergoing PCI After High Dose Clopidogrel Pretreatment (BRAVE 3) |
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Date of first enrolment:
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June 2003 |
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Target sample size:
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800 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00133250 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Austria
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Germany
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Contacts
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Name:
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Adnan Kastrati, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Deutsches Herzzentrum Muenchen |
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Name:
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Albert Schomig, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Deutsches Herzzentrum Muenchen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients presenting with ST-Elevation acute myocardial infarction within 24 hours
from the onset of symptoms
Exclusion Criteria:
- Age >80 years
- Malignancies
- Cardiogenic shock
- Prolonged cardio-pulmonary resuscitation
- Increased risk of bleeding
- Relevant hematologic deviations (hemoglobin <100 g/L or hematocrit <34%, platelet
count <100 x 10^9 /L or platelet count >600 x 10^9 /L)
- Known allergy to the study medication
- Pregnancy (present or suspected)
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myocardial Infarction
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Intervention(s)
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Drug: Abciximab
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Other: Placebo Heparin Sodium
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Primary Outcome(s)
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Left ventricular infarct size calculated as the final perfusion defect at follow-up scintigraphic study
[Time Frame: 5-7 days]
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Secondary Outcome(s)
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Clinical adverse events (death of any cause, reinfarction, stroke, urgent reinterventions, major and minor bleeding complications, thrombocytopenia <20 x 10^9 /L)
[Time Frame: 30 days]
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Secondary ID(s)
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GE IDE No. I00902
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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