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Completed

NCT Number: NCT00882739

Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction

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.

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, 52100, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clopidogrel 300 mg

Drug

Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting

Other names: Plavix-®

Clopidogrel 600 mg

Drug

Patients will receive a 600 mg clopidogrel loading dose at first medical contact

Other names: Plavix-®

Clopidogrel 900 mg

Drug

Patients will receive a 900 mg clopidogrel loading dose at first medical contact

Other names: Plavix-®

Primary outcomes

  1. TIMI Myocardial Perfusion Grade (TMPG)

    Time frame: post-PCI

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ospedale San Donato

Other

Registry information

Official study 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

Acronym: Load & Go

Important dates

Study start
2009
Primary completion
2011
First posted
Apr 16, 2009
Registry last updated
Jan 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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