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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
Sponsor:
Information provided by (Responsible Party):
Leonardo Bolognese, Ospedale San Donato

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Clopidogrel 300 mg Drug: Clopidogrel 600 mg Drug: Clopidogrel 900 mg Phase 4

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).


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2009
Actual Primary Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
no pre-treatment
No pre-treatment at first medical contact - Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting
 Drug: Clopidogrel 300 mg
Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting
Other Name: Plavix-®
Experimental: 600 mg loading dose
600 mg clopidogrel loading dose at first medical contact
 Drug: Clopidogrel 600 mg
Patients will receive a 600 mg clopidogrel loading dose at first medical contact
Other Name: Plavix-®
Experimental: 900 mg loading dose
900 mg clopidogrel loading dose at first medical contact
 Drug: Clopidogrel 900 mg
Patients will receive a 900 mg clopidogrel loading dose at first medical contact
Other Name: Plavix-®


Outcome Measures
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Primary Outcome Measures :
  1. TIMI Myocardial Perfusion Grade (TMPG) [ Time Frame: post-PCI ]

Secondary Outcome Measures :
  1. TIMI flow [ Time Frame: pre- and post-PCI ]
  2. Corrected TIMI Frame Count (cTFC) [ Time Frame: post-PCI ]
  3. Major bleedings [ Time Frame: 30 days ]
  4. Major adverse cardiac events (MACEs) [ Time Frame: 30 days ]
  5. Platelet Reactive Units (PRU) as assessed by VerifyNow™ System [ Time Frame: pre-PCI ]
  6. TIMI 2-3 grade flow of the infarct-related artery [ Time Frame: pre-PCI ]
  7. no reflow phenomenon [ Time Frame: post-PCI ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ST-elevation myocardial infarction:

    • chest pain lasting more than 30 minutes
    • not responsive to nitrates
    • ST-segment elevation of more than 0.1 mV in two or more leads on the ECG, or new Left Bundle Branch Block
  • With indication to primary PCI, presenting within 12 hour from symptoms onset
  • Age > 18 years
  • Planned PCI
  • Informed Consent

Exclusion Criteria:

  • bleeding diathesis
  • allergy to study drugs
  • pregnancy
  • the performance of a rescue PCI after thrombolysis
  • known existence of a disease resulting in a life expectancy of <6 months
  • lack of informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00882739


Locations
Italy
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy, 52100
Sponsors and Collaborators
Ospedale San Donato
Investigators
Principal Investigator: Leonardo Bolognese, MD, FESC Ospedale San Donato
Principal Investigator: Kenneth Ducci, MD Ospedale San Donato
More Information
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Responsible Party: Leonardo Bolognese, MD, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT00882739     History of Changes
Other Study ID Numbers: Arezzo002
EUDRACT 2009-010295-23
First Posted: April 16, 2009    Key Record Dates
Last Update Posted: January 26, 2012
Last Verified: January 2012

Keywords provided by Leonardo Bolognese, Ospedale San Donato:
angiography
percutaneous coronary intervention
Platelet Aggregation Inhibitors
Platelet Function Tests

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
 Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors