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

This study is currently recruiting participants.
Verified April 2012 by Campus Bio-Medico University
Sponsor:
Information provided by (Responsible Party):
Patti Giuseppe, Campus Bio-Medico University
ClinicalTrials.gov Identifier:
NCT01572129
First received: April 3, 2012
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Acute Coronary Syndrome
Myocardial Infarction
 Drug: Clopidogrel
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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.

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Campus Bio-Medico University:

Primary Outcome Measures:
  • Major Adverse Cardiovascular Events [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Death Myocardial Infarction Target Vessel Revascularization


Secondary Outcome Measures:
  • Bleeding Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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)

  • Grade of platelet residual reactivity [ Time Frame: Immediately before PCI (4-6h after randomization), 8h and 24h after PCI ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 240
Study Start Date: November 2011
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572129

Contacts
Contact: Giuseppe Patti, MD 06225411899 g.patti@unicampus.it

Locations
Italy
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
Investigators
Principal Investigator: Giuseppe Patti, MD Campus Bio-Medico University
  More Information

Publications:

Responsible Party: Patti Giuseppe, MD, FACC, Co-Chair of the ARMYDA Study Group, Assistant Professor of Cardiology, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT01572129     History of Changes
Other Study ID Numbers: 2011-005449-11
Study First Received: April 3, 2012
Last Updated: April 4, 2012
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
 Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013