NCT00882739

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Last Updated

January 26, 2012

Status Verified

January 1, 2012

Enrollment Period

2.2 years

First QC Date

April 15, 2009

Last Update Submit

January 25, 2012

Conditions

Acute Myocardial Infarction

Keywords

angiographypercutaneous coronary interventionPlatelet Aggregation InhibitorsPlatelet Function Tests

Outcome Measures

Primary Outcomes (1)

  • TIMI Myocardial Perfusion Grade (TMPG)

    post-PCI

Secondary Outcomes (7)

  • TIMI flow

    pre- and post-PCI

  • Corrected TIMI Frame Count (cTFC)

    post-PCI

  • Major bleedings

    30 days

  • Major adverse cardiac events (MACEs)

    30 days

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

    pre-PCI

  • +2 more secondary outcomes

Study Arms (3)

no pre-treatment

OTHER

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

600 mg loading dose

EXPERIMENTAL

600 mg clopidogrel loading dose at first medical contact

Drug: Clopidogrel 600 mg

900 mg loading dose

EXPERIMENTAL

900 mg clopidogrel loading dose at first medical contact

Drug: Clopidogrel 900 mg

Interventions

Clopidogrel 300 mgDRUG

Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting

Also known as: Plavix-®
no pre-treatment
Clopidogrel 600 mgDRUG

Patients will receive a 600 mg clopidogrel loading dose at first medical contact

Also known as: Plavix-®
600 mg loading dose
Clopidogrel 900 mgDRUG

Patients will receive a 900 mg clopidogrel loading dose at first medical contact

Also known as: Plavix-®
900 mg loading dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, 52100, Italy

Location

MeSH Terms

Interventions

Clopidogrel

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Leonardo Bolognese, MD, FESC

    Ospedale San Donato

    PRINCIPAL INVESTIGATOR

  • Kenneth Ducci, MD

    Ospedale San Donato

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 15, 2009

First Posted

April 16, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2011

Last Updated

January 26, 2012

Record last verified: 2012-01

Locations

IT(1)