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

Sponsor:	Ospedale San Donato
Information provided by (Responsible Party):	Leonardo Bolognese, Ospedale San Donato
ClinicalTrials.gov Identifier:	NCT00882739

Purpose

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.

Condition	Intervention	Phase
Acute Myocardial Infarction	Drug: Clopidogrel 300 mg Drug: Clopidogrel 600 mg Drug: Clopidogrel 900 mg	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Heart Attack

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Ospedale San Donato:

Primary Outcome Measures:

TIMI Myocardial Perfusion Grade (TMPG) [ Time Frame: post-PCI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Enrollment:	168
Study Start Date:	April 2009
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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-®

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882739

Locations

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

Sponsors and Collaborators

Ospedale San Donato

Investigators

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

More Information

No publications provided

Responsible Party:	Leonardo Bolognese, MD, Ospedale San Donato
ClinicalTrials.gov Identifier:	NCT00882739 History of Changes
Other Study ID Numbers:	Arezzo002, EUDRACT 2009-010295-23
Study First Received:	April 15, 2009
Last Updated:	January 25, 2012
Health Authority:	Italy: Ethics Committee

Keywords provided by Ospedale San Donato:

angiography
percutaneous coronary intervention
Platelet Aggregation Inhibitors
Platelet Function Tests

Additional relevant MeSH terms:

Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Ticlopidine
Hematologic Agents

Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012