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

Sponsored by:	Ospedale San Donato
Information provided by:	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

MedlinePlus related topics: Angioplasty Heart Attack

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

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

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 ]
ST segment resolution [ Time Frame: 90' and 180' after primary PCI ] [ Designated as safety issue: No ]
Major and minor bleedings [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Major adverse cardiac events (MACEs) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Platelet Reactive Units (PRU) as assessed by VerifyNow™ System [ Time Frame: pre-PCI ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	April 2009
Estimated Primary Completion Date:	April 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
600 mg loading dose: Experimental 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
900 mg loading dose: Experimental 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

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 0.2 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

Contacts and Locations

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

Contacts

Contact: Leonardo Bolognese, MD, FESC

+390575255529

leonardobolognese@hotmail.com

Locations

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

Sponsors and Collaborators

Ospedale San Donato

Investigators

Principal Investigator:

Leonardo Bolognese, MD, FESC

Ospedale San Donato

More Information

No publications provided

Responsible Party:	Ospedale San Donato ( Cardiovascular Department USL 8(Leonardo Bolognese MD) )
Study ID Numbers:	Arezzo002, EUDRACT 2009-010295-23
Study First Received:	April 15, 2009
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00882739 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by Ospedale San Donato:

angiography
percutaneous coronary intervention
Platelet Aggregation Inhibitors
Platelet Function Tests

Study placed in the following topic categories:

Necrosis
Heart Diseases
Clopidogrel
Myocardial Ischemia
Vascular Diseases

Platelet Aggregation Inhibitors
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Heart Diseases
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Ischemia
Pharmacologic Actions
Necrosis

Pathologic Processes
Clopidogrel
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 06, 2009