NCT01572129

Brief Summary

Patients who developed an acute coronary syndrome despite dual antiplatelet therapy with aspirin and clopidogrel may benefit from a further dose of clopidogrel before a percutaneous coronary intervention. The aim of this study is to evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy with acute coronary syndrome undergoing percutaneous coronary intervention.

Trial Health

55
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Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

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

November 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

6 months

First QC Date

April 3, 2012

Last Update Submit

April 4, 2012

Conditions

Acute Coronary SyndromeMyocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiovascular Events

    Death Myocardial Infarction Target Vessel Revascularization

    30 days

Secondary Outcomes (2)

  • Bleeding Events

    30 days

  • Grade of platelet residual reactivity

    Immediately before PCI (4-6h after randomization), 8h and 24h after PCI

Study Arms (2)

Reload

EXPERIMENTAL

600 mg of clopidogrel loading dose 6-8 h before coronary angiogram, in addition to the chronic daily dose of 75 mg

Drug: Clopidogrel

Placebo

PLACEBO COMPARATOR

Placebo arm in addition to the chronic daily dose of 75 mg

Drug: Placebo

Interventions

ClopidogrelDRUG

600 mg clopidogrel loading dose 6-8 h before diagnostic coronary angiogram

Also known as: Plavix
Reload
PlaceboDRUG

Placebo in addition to the chronic daily dose of 75 mg

Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic (\> 10 days) therapy with clopidogrel (75 mg/day)
  • non-ST-segment elevation acute coronary syndrome (ACS) requiring early diagnostic angiography

You may not qualify if:

  • primary percutaneous coronary intervention (PCI) for acute ST-segment elevation acute myocardial infarction
  • platelet count \< 70 Ă— 10\^9/L
  • high bleeding risk
  • coronary bypass grafting in the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vito Fazzi Hospital

Lecce, Lecce, 73100, Italy

RECRUITING

Campus Bio-Medico University

Rome, Rome, 00128, Italy

RECRUITING

Related Publications (2)

  • Di Sciascio G, Patti G, Pasceri V, Colonna G, Mangiacapra F, Montinaro A; ARMYDA-4 RELOAD Investigators. Clopidogrel reloading in patients undergoing percutaneous coronary intervention on chronic clopidogrel therapy: results of the ARMYDA-4 RELOAD (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) randomized trial. Eur Heart J. 2010 Jun;31(11):1337-43. doi: 10.1093/eurheartj/ehq081. Epub 2010 Apr 2.

    PMID: 20363764BACKGROUND

  • Kastrati A, von Beckerath N, Joost A, Pogatsa-Murray G, Gorchakova O, Schomig A. Loading with 600 mg clopidogrel in patients with coronary artery disease with and without chronic clopidogrel therapy. Circulation. 2004 Oct 5;110(14):1916-9. doi: 10.1161/01.CIR.0000137972.74120.12. Epub 2004 Jul 19.

    PMID: 15262828BACKGROUND

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial Infarction

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Giuseppe Patti, MD

    Campus Bio-Medico University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Patti, MD

CONTACT

06225411899g.patti@unicampus.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FACC, Co-Chair of the ARMYDA Study Group, Assistant Professor of Cardiology

Study Record Dates

First Submitted

April 3, 2012

First Posted

April 6, 2012

Study Start

November 1, 2011

Primary Completion

May 1, 2012

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations

IT(2)