Clopidogrel Reloading in Patients With NSTEACS Undergoing Percutaneous Coronary Intervention on Chronic Clopidogrel Therapy

NCT ID: NCT01572129

Last Updated: 2012-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Coronary Syndrome Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Reload

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

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo in addition to the chronic daily dose of 75 mg

Interventions

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Clopidogrel

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

Intervention Type DRUG

Placebo

Placebo in addition to the chronic daily dose of 75 mg

Intervention Type DRUG

Other Intervention Names

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Plavix

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Campus Bio-Medico University

OTHER

Sponsor Role lead

Responsible Party

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Patti Giuseppe

MD, FACC, Co-Chair of the ARMYDA Study Group, Assistant Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe Patti, MD

Role: PRINCIPAL_INVESTIGATOR

Campus Bio-Medico University

Locations

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Vito Fazzi Hospital

Lecce, Lecce, Italy

Site Status RECRUITING

Campus Bio-Medico University

Rome, Rome, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giuseppe Patti, MD

Role: CONTACT

06225411899

References

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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.

Reference Type BACKGROUND
PMID: 20363764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15262828 (View on PubMed)

Other Identifiers

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2011-005449-11

Identifier Type: -

Identifier Source: org_study_id

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