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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01572129
Recruitment Status : Unknown
Verified April 2012 by Patti Giuseppe, Campus Bio-Medico University.
Recruitment status was:  Recruiting
First Posted : April 6, 2012
Last Update Posted : April 6, 2012
Information provided by (Responsible Party):
Patti Giuseppe, Campus Bio-Medico University

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Myocardial Infarction Drug: Clopidogrel Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Clopidogrel Reloading in Patients With Non-ST Elevation Acute Coronary Syndrome Undergoing PCI on Chronic Clopidogrel Therapy. Results of the ARMYDA RELOAD ACS (Antiplatelet Therapy for Reduction of MYocardial Damage During Angioplasty in Acute Coronary Syndrome) Randomized Trial.
Study Start Date : November 2011
Estimated Primary Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Reload
600 mg of clopidogrel loading dose 6-8 h before coronary angiogram, in addition to the chronic daily dose of 75 mg
Drug: Clopidogrel
600 mg clopidogrel loading dose 6-8 h before diagnostic coronary angiogram
Other Name: Plavix

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

Primary Outcome Measures :
  1. Major Adverse Cardiovascular Events [ Time Frame: 30 days ]
    Death Myocardial Infarction Target Vessel Revascularization

Secondary Outcome Measures :
  1. Bleeding Events [ Time Frame: 30 days ]
    Occurrence of vascular/bleeding complications, defined as: (a) major bleeding (intracranial bleeding or clinically overt bleeding associated with a decrease in haemoglobin >5 g/dL, according to the TIMI criteria); (b) minor bleeding (clinically overt haemorrhage associated with a fall in haemoglobin ≤5 g/dL); (c) entry-site complications (haematoma >5 cm, pseudoaneurysm or arteriovenous fistula)

  2. Grade of platelet residual reactivity [ Time Frame: Immediately before PCI (4-6h after randomization), 8h and 24h after PCI ]

    Patient's response to clopidogrel at 3 different timing, assessed with VerifyNow P2Y12 Assays.

    The first timing is immediately before PCI (4-6h after randomization), once accomplished the diagnostic angiogram.

    The second and third timings are, respectively, 8h and 24h after PCI.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01572129

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Contact: Giuseppe Patti, MD 06225411899

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Vito Fazzi Hospital Recruiting
Lecce, Italy, 73100
Principal Investigator: Giuseppe Colonna, MD         
Sub-Investigator: Antonio Montinaro, MD         
Campus Bio-Medico University Recruiting
Rome, Italy, 00128
Principal Investigator: Giuseppe Patti, MD         
Sub-Investigator: Vincenzo Vizzi, MD         
Sub-Investigator: Elisabetta Ricottini, MD         
Sub-Investigator: Fabio Mangiacapra, MD         
Sponsors and Collaborators
Campus Bio-Medico University
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Principal Investigator: Giuseppe Patti, MD Campus Bio-Medico University

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Responsible Party: Patti Giuseppe, MD, FACC, Co-Chair of the ARMYDA Study Group, Assistant Professor of Cardiology, Campus Bio-Medico University Identifier: NCT01572129    
Other Study ID Numbers: 2011-005449-11
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: April 6, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs