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

Myocardial Infarction Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01572129
• Other study ID #: 2011-005449-11
• Status: Recruiting
• Phase: Phase 4
• First received: April 3, 2012
• Last updated: April 4, 2012
• Start date: November 2011

Study information

• Verified date: April 2012
• Source: Campus Bio-Medico University
• Contact: Giuseppe Patti, MD
• Phone: 06225411899
• Email: g.patti[@]unicampus.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Myocardial Infarction

Intervention

Drug:
• Clopidogrel
600 mg clopidogrel loading dose 6-8 h before diagnostic coronary angiogram
• Placebo
Placebo in addition to the chronic daily dose of 75 mg

Locations

Country	Name	City	State
Italy	Vito Fazzi Hospital	Lecce
Italy	Campus Bio-Medico University	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

Kastrati A, von Beckerath N, Joost A, Pogatsa-Murray G, Gorchakova O, Schömig 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. Epub 2004 Jul 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiovascular Events	Death Myocardial Infarction Target Vessel Revascularization	30 days	No
Secondary	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)	30 days	Yes
Secondary	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.	Immediately before PCI (4-6h after randomization), 8h and 24h after PCI	No