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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
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
 (submitted: April 15, 2009)
TIMI Myocardial Perfusion Grade (TMPG) [ Time Frame: post-PCI ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2012)
  • TIMI flow [ Time Frame: pre- and post-PCI ]
  • Corrected TIMI Frame Count (cTFC) [ Time Frame: post-PCI ]
  • Major bleedings [ Time Frame: 30 days ]
  • Major adverse cardiac events (MACEs) [ Time Frame: 30 days ]
  • Platelet Reactive Units (PRU) as assessed by VerifyNow™ System [ Time Frame: pre-PCI ]
  • TIMI 2-3 grade flow of the infarct-related artery [ Time Frame: pre-PCI ]
  • no reflow phenomenon [ Time Frame: post-PCI ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2009)
  • TIMI flow [ Time Frame: pre- and post-PCI ]
  • Corrected TIMI Frame Count (cTFC) [ Time Frame: post-PCI ]
  • ST segment resolution [ Time Frame: 90' and 180' after primary PCI ]
  • Major and minor bleedings [ Time Frame: 1 year ]
  • Major adverse cardiac events (MACEs) [ Time Frame: 1 year ]
  • Platelet Reactive Units (PRU) as assessed by VerifyNow™ System [ Time Frame: pre-PCI ]
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).

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
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE
  • 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-®
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2012)
168
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2009)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
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
Principal Investigator: Leonardo Bolognese, MD, FESC Ospedale San Donato
Principal Investigator: Kenneth Ducci, MD Ospedale San Donato
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