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Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction (Load & Go)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leonardo Bolognese, Ospedale San Donato
ClinicalTrials.gov Identifier:
NCT00882739
First received: April 15, 2009
Last updated: January 25, 2012
Last verified: January 2012

April 15, 2009
January 25, 2012
April 2009
July 2011   (final data collection date for primary outcome measure)
TIMI Myocardial Perfusion Grade (TMPG) [ Time Frame: post-PCI ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00882739 on ClinicalTrials.gov Archive Site
  • TIMI flow [ Time Frame: pre- and post-PCI ] [ Designated as safety issue: No ]
  • Corrected TIMI Frame Count (cTFC) [ Time Frame: post-PCI ] [ Designated as safety issue: No ]
  • Major bleedings [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Major adverse cardiac events (MACEs) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Platelet Reactive Units (PRU) as assessed by VerifyNow™ System [ Time Frame: pre-PCI ] [ Designated as safety issue: No ]
  • TIMI 2-3 grade flow of the infarct-related artery [ Time Frame: pre-PCI ] [ Designated as safety issue: No ]
  • no reflow phenomenon [ Time Frame: post-PCI ] [ Designated as safety issue: No ]
  • TIMI flow [ Time Frame: pre- and post-PCI ] [ Designated as safety issue: No ]
  • Corrected TIMI Frame Count (cTFC) [ Time Frame: post-PCI ] [ Designated as safety issue: No ]
  • ST segment resolution [ Time Frame: 90' and 180' after primary PCI ] [ Designated as safety issue: No ]
  • Major and minor bleedings [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Major adverse cardiac events (MACEs) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Platelet Reactive Units (PRU) as assessed by VerifyNow™ System [ Time Frame: pre-PCI ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction
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

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.

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Drug: Clopidogrel 300 mg
    Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting
    Other Name: Plavix-®
  • Drug: Clopidogrel 600 mg
    Patients will receive a 600 mg clopidogrel loading dose at first medical contact
    Other Name: Plavix-®
  • Drug: Clopidogrel 900 mg
    Patients will receive a 900 mg clopidogrel loading dose at first medical contact
    Other Name: Plavix-®
  • no pre-treatment
    No pre-treatment at first medical contact - Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting
    Intervention: Drug: Clopidogrel 300 mg
  • Experimental: 600 mg loading dose
    600 mg clopidogrel loading dose at first medical contact
    Intervention: Drug: Clopidogrel 600 mg
  • Experimental: 900 mg loading dose
    900 mg clopidogrel loading dose at first medical contact
    Intervention: Drug: Clopidogrel 900 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
Not Provided
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00882739
Arezzo002, EUDRACT 2009-010295-23
No
Leonardo Bolognese, Ospedale San Donato
Ospedale San Donato
Not Provided
Principal Investigator: Leonardo Bolognese, MD, FESC Ospedale San Donato
Principal Investigator: Kenneth Ducci, MD Ospedale San Donato
Ospedale San Donato
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP