Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction
Information source: Ospedale San Donato
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myocardial Infarction
Intervention: Clopidogrel 300 mg (Drug); Clopidogrel 600 mg (Drug); Clopidogrel 900 mg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Ospedale San Donato Official(s) and/or principal investigator(s): Leonardo Bolognese, MD, FESC, Principal Investigator, Affiliation: Ospedale San Donato Kenneth Ducci, MD, Principal Investigator, Affiliation: Ospedale San Donato
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: TIMI Myocardial Perfusion Grade (TMPG)
Secondary outcome: TIMI flowCorrected 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
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Cardiovascular Department, Ospedale S.Donato, Arezzo, AR 52100, Italy
Additional Information
Starting date: April 2009
Last updated: January 25, 2012
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