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

Acute Myocardial Infarction Clinical Trial

— Load & Go  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882739
• Other study ID #: Arezzo002
• Secondary ID: EUDRACT 2009-010
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2009
• Last updated: January 25, 2012
• Start date: April 2009

Study information

• Verified date: January 2012
• Source: Ospedale San Donato
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Clopidogrel 300 mg
Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting
• Clopidogrel 600 mg
Patients will receive a 600 mg clopidogrel loading dose at first medical contact
• Clopidogrel 900 mg
Patients will receive a 900 mg clopidogrel loading dose at first medical contact

Locations

Country	Name	City	State
Italy	Cardiovascular Department, Ospedale S.Donato	Arezzo	AR

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIMI Myocardial Perfusion Grade (TMPG)		post-PCI	No
Secondary	TIMI flow		pre- and post-PCI	No
Secondary	Corrected TIMI Frame Count (cTFC)		post-PCI	No
Secondary	Major bleedings		30 days	Yes
Secondary	Major adverse cardiac events (MACEs)		30 days	No
Secondary	Platelet Reactive Units (PRU) as assessed by VerifyNow™ System		pre-PCI	No
Secondary	TIMI 2-3 grade flow of the infarct-related artery		pre-PCI	No
Secondary	no reflow phenomenon		post-PCI	No