Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction (Load & Go)
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ClinicalTrials.gov Identifier: NCT00882739 |
Recruitment Status :
Completed
First Posted : April 16, 2009
Last Update Posted : January 26, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myocardial Infarction | Drug: Clopidogrel 300 mg Drug: Clopidogrel 600 mg Drug: Clopidogrel 900 mg | Phase 4 |
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 (Clinical Trial) |
Actual Enrollment : | 168 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | July 2011 |

Arm | Intervention/treatment |
---|---|
no pre-treatment
No pre-treatment at first medical contact - Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting
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Drug: Clopidogrel 300 mg
Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting
Other Name: 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 Name: 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 Name: Plavix-® |
- TIMI Myocardial Perfusion Grade (TMPG) [ Time Frame: post-PCI ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00882739
Italy | |
Cardiovascular Department, Ospedale S.Donato | |
Arezzo, AR, Italy, 52100 |
Principal Investigator: | Leonardo Bolognese, MD, FESC | Ospedale San Donato | |
Principal Investigator: | Kenneth Ducci, MD | Ospedale San Donato |
Responsible Party: | Leonardo Bolognese, MD, Ospedale San Donato |
ClinicalTrials.gov Identifier: | NCT00882739 |
Other Study ID Numbers: |
Arezzo002 EUDRACT 2009-010295-23 |
First Posted: | April 16, 2009 Key Record Dates |
Last Update Posted: | January 26, 2012 |
Last Verified: | January 2012 |
angiography percutaneous coronary intervention Platelet Aggregation Inhibitors Platelet Function Tests |
Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
Clopidogrel Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |