Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction (Load & Go)
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Clopidogrel 300 mg
Clopidogrel 600 mg
Clopidogrel 900 mg
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring angiography, percutaneous coronary intervention, Platelet Aggregation Inhibitors, Platelet Function Tests
Eligibility 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
Sites / Locations
- Cardiovascular Department, Ospedale S.Donato
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
no pre-treatment
600 mg loading dose
900 mg loading dose
Arm Description
No pre-treatment at first medical contact - Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting
600 mg clopidogrel loading dose at first medical contact
900 mg clopidogrel loading dose at first medical contact
Outcomes
Primary Outcome Measures
TIMI Myocardial Perfusion Grade (TMPG)
Secondary Outcome Measures
TIMI flow
Corrected TIMI Frame Count (cTFC)
Major bleedings
Major adverse cardiac events (MACEs)
Platelet Reactive Units (PRU) as assessed by VerifyNow™ System
TIMI 2-3 grade flow of the infarct-related artery
no reflow phenomenon
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00882739
Brief Title
Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale San Donato
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
angiography, percutaneous coronary intervention, Platelet Aggregation Inhibitors, Platelet Function Tests
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no pre-treatment
Arm Type
Other
Arm Description
No pre-treatment at first medical contact - Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting
Arm Title
600 mg loading dose
Arm Type
Experimental
Arm Description
600 mg clopidogrel loading dose at first medical contact
Arm Title
900 mg loading dose
Arm Type
Experimental
Arm Description
900 mg clopidogrel loading dose at first medical contact
Intervention Type
Drug
Intervention Name(s)
Clopidogrel 300 mg
Other Intervention Name(s)
Plavix-®
Intervention Description
Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting
Intervention Type
Drug
Intervention Name(s)
Clopidogrel 600 mg
Other Intervention Name(s)
Plavix-®
Intervention Description
Patients will receive a 600 mg clopidogrel loading dose at first medical contact
Intervention Type
Drug
Intervention Name(s)
Clopidogrel 900 mg
Other Intervention Name(s)
Plavix-®
Intervention Description
Patients will receive a 900 mg clopidogrel loading dose at first medical contact
Primary Outcome Measure Information:
Title
TIMI Myocardial Perfusion Grade (TMPG)
Time Frame
post-PCI
Secondary Outcome Measure Information:
Title
TIMI flow
Time Frame
pre- and post-PCI
Title
Corrected TIMI Frame Count (cTFC)
Time Frame
post-PCI
Title
Major bleedings
Time Frame
30 days
Title
Major adverse cardiac events (MACEs)
Time Frame
30 days
Title
Platelet Reactive Units (PRU) as assessed by VerifyNow™ System
Time Frame
pre-PCI
Title
TIMI 2-3 grade flow of the infarct-related artery
Time Frame
pre-PCI
Title
no reflow phenomenon
Time Frame
post-PCI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Bolognese, MD, FESC
Organizational Affiliation
Ospedale San Donato
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth Ducci, MD
Organizational Affiliation
Ospedale San Donato
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Department, Ospedale S.Donato
City
Arezzo
State/Province
AR
ZIP/Postal Code
52100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction
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