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

Condition(s) targeted: Acute Myocardial Infarction

Intervention: Clopidogrel 300 mg (Drug); Clopidogrel 600 mg (Drug); Clopidogrel 900 mg (Drug)

Phase: Phase 4

Status: Recruiting

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

Overall contact:
Kenneth Ducci, MD, Phone: +390575255617, Email: kducci@gmail.com

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.

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: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: TIMI Myocardial Perfusion Grade (TMPG)

Secondary outcome:

TIMI flow

Corrected TIMI Frame Count (cTFC)

ST segment resolution

Major and minor bleedings

Major adverse cardiac events (MACEs)

Platelet Reactive Units (PRU) as assessed by VerifyNow™ System

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).

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. 2 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:

- History of bleeding diathesis, or allergy/intolerance to study drugs; current or

indicated oral anticoagulant therapy

- Major surgery within 1 month

- History of ischemic stroke within 6 months

- Uncontrolled Arterial Hypertension (Systolic or Diastolic Blood Pressure>180 mmHg or

>120 mmHg respectively)

- Pregnancy

Kenneth Ducci, MD, Phone: +390575255617, Email: kducci@gmail.com

Cardiovascular Department, Ospedale S.Donato, Arezzo, AR 52100, Italy; Recruiting
Kenneth J Ducci, MD, Email: kducci@gmail.com
Leonardo Bolognese, MD, FESC, Principal Investigator
Kenneth Ducci, MD, Principal Investigator
Simone Grotti, MD, Sub-Investigator
Paolo Angioli, MD, Sub-Investigator
Giovanni Falsini, MD, Sub-Investigator
Francesco Liistro, MD, Sub-Investigator

Starting date: April 2009
Last updated: May 20, 2009