Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction (Load & Go)
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ClinicalTrials.gov Identifier: NCT00882739 |
Recruitment Status :
Completed
First Posted : April 16, 2009
Last Update Posted : January 26, 2012
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Sponsor:
Ospedale San Donato
Information provided by (Responsible Party):
Leonardo Bolognese, Ospedale San Donato
Tracking Information | |||||||
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First Submitted Date ICMJE | April 15, 2009 | ||||||
First Posted Date ICMJE | April 16, 2009 | ||||||
Last Update Posted Date | January 26, 2012 | ||||||
Study Start Date ICMJE | April 2009 | ||||||
Actual Primary Completion Date | July 2011 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
TIMI Myocardial Perfusion Grade (TMPG) [ Time Frame: post-PCI ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction | ||||||
Official Title ICMJE | Safety and Efficacy of Three Different Loading Doses of Clopidogrel, Administered at First Medical Contact in Patients With Acute Myocardial Infarction Undergoing Primary Angioplasty. The LOAD & GO Trial | ||||||
Brief Summary | The aim of this study is to determine both safety and effectiveness of three different loading dose regimens of clopidogrel in patients with acute myocardial infarction undergoing primary angioplasty. | ||||||
Detailed Description | This study will enroll STEMI patients, who were planned to undergo PCI, and will randomize them to three different clopidogrel loading dose regimens at first medical contact: no pre-treatment, 600 mg or 900 mg. Platelet activity after administration of clopidogrel will be evaluated by VerifyNow™ P2Y12 point-of-care system. The study is powered to demonstrate significant differences in the primary end point (the rate of TIMI Myocardial Perfusion Grade=3). |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Acute Myocardial Infarction | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
168 | ||||||
Original Estimated Enrollment ICMJE |
150 | ||||||
Study Completion Date ICMJE | Not Provided | ||||||
Actual Primary Completion Date | July 2011 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Italy | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00882739 | ||||||
Other Study ID Numbers ICMJE | Arezzo002 EUDRACT 2009-010295-23 |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Leonardo Bolognese, Ospedale San Donato | ||||||
Study Sponsor ICMJE | Ospedale San Donato | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Ospedale San Donato | ||||||
Verification Date | January 2012 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |