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

January 25, 2012 updated by: Leonardo Bolognese, Ospedale San Donato

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

168

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • AR
      • Arezzo, AR, Italy, 52100
        • Cardiovascular Department, Ospedale S.Donato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • 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 Names:
  • 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 Names:
  • Plavix-®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TIMI Myocardial Perfusion Grade (TMPG)
Time Frame: post-PCI
post-PCI

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Donato

Investigators

  • Principal Investigator: Leonardo Bolognese, MD, FESC, Ospedale San Donato
  • Principal Investigator: Kenneth Ducci, MD, Ospedale San Donato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

April 15, 2009

First Submitted That Met QC Criteria

April 15, 2009

First Posted (Estimate)

April 16, 2009

Study Record Updates

Last Update Posted (Estimate)

January 26, 2012

Last Update Submitted That Met QC Criteria

January 25, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arezzo002
  • EUDRACT 2009-010295-23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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