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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 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

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

Page last updated: August 23, 2015

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