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

• ClinicalTrials.gov Identifier: NCT00882739
• Recruitment Status: Completed
• First Posted: April 16, 2009
• Last Update Posted: January 26, 2012
• Sponsor: Ospedale San Donato
• Information provided by (Responsible Party): Leonardo Bolognese, Ospedale San Donato

Tracking Information

• First Submitted Date: April 15, 2009
• First Posted Date: April 16, 2009
• Last Update Posted Date: January 26, 2012
• Study Start Date: April 2009
• Actual Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 15, 2009): TIMI Myocardial Perfusion Grade (TMPG) [ Time Frame: post-PCI ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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 (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: Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction
• 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acute Myocardial Infarction

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 25, 2012): 168
• Original Estimated Enrollment (submitted: April 15, 2009): 150
• Study Completion Date: Not Provided
• Actual Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT00882739
• Other Study ID Numbers: Arezzo002; EUDRACT 2009-010295-23
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Leonardo Bolognese, Ospedale San Donato
• Study Sponsor: Ospedale San Donato
• Collaborators: Not Provided

Investigators

• 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