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

Tracking Information

First Received Date ^ICMJE

April 3, 2012

Last Updated Date

April 4, 2012

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Major Adverse Cardiovascular Events [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Death Myocardial Infarction Target Vessel Revascularization

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01572129 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention

Condition ^ICMJE

Acute Coronary Syndrome
Myocardial Infarction

Intervention ^ICMJE

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

Other Name: Plavix
Drug: Placebo
Placebo in addition to the chronic daily dose of 75 mg

Study Arm (s)

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

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

Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

240

Completion Date

Not Provided

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Giuseppe Patti, MD

06225411899

g.patti@unicampus.it

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01572129

Other Study ID Numbers ^ICMJE

2011-005449-11

Has Data Monitoring Committee

Responsible Party

Patti Giuseppe, Campus Bio-Medico University

Study Sponsor ^ICMJE

Campus Bio-Medico University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Giuseppe Patti, MD

Campus Bio-Medico University

Information Provided By

Campus Bio-Medico University

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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