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

Primary Purpose

Acute Coronary Syndrome, Myocardial Infarction

Status

Unknown status

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Clopidogrel

Placebo

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vito Fazzi HospitalRecruiting
Campus Bio-Medico UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Reload

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Major Adverse Cardiovascular Events

Death Myocardial Infarction Target Vessel Revascularization

Secondary Outcome Measures

Bleeding Events

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

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.

Full Information

NCT ID

NCT01572129

First Posted

April 3, 2012

Last Updated

April 4, 2012

Sponsor

Campus Bio-Medico University

1. Study Identification

Unique Protocol Identification Number

NCT01572129

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Unknown status

Study Start Date

November 2011 (undefined)

Primary Completion Date

May 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Campus Bio-Medico University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome, Myocardial Infarction

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Reload

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Other Intervention Name(s)

Plavix

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo in addition to the chronic daily dose of 75 mg

Primary Outcome Measure Information:

Title

Major Adverse Cardiovascular Events

Description

Death Myocardial Infarction Target Vessel Revascularization

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Bleeding Events

Description

Time Frame

30 days

Title

Grade of platelet residual reactivity

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Giuseppe Patti, MD

Phone

06225411899

g.patti@unicampus.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giuseppe Patti, MD

Organizational Affiliation

Campus Bio-Medico University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vito Fazzi Hospital

City

Lecce

ZIP/Postal Code

73100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giuseppe Colonna, MD

First Name & Middle Initial & Last Name & Degree

Antonio Montinaro, MD

Facility Name

Campus Bio-Medico University

City

Rome

ZIP/Postal Code

00128

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giuseppe Patti, MD

First Name & Middle Initial & Last Name & Degree

Vincenzo Vizzi, MD

First Name & Middle Initial & Last Name & Degree

Elisabetta Ricottini, MD

First Name & Middle Initial & Last Name & Degree

Fabio Mangiacapra, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

20363764

Citation

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.

Results Reference

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PubMed Identifier

15262828

Citation

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.

Results Reference

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

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