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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00882739

Acronym

Load & Go

Enrollment

168

Registered

2009-04-16

Start date

2009-04-30

Completion date

Unknown

Last updated

2012-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

angiography, percutaneous coronary intervention, Platelet Aggregation Inhibitors, Platelet Function Tests

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).

Interventions

DRUGClopidogrel 300 mg

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

DRUGClopidogrel 600 mg

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

DRUGClopidogrel 900 mg

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
TIMI Myocardial Perfusion Grade (TMPG)	post-PCI

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026