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

Phase 4

• Conditions: Acute Coronary Syndrome; Myocardial Infarction
• Interventions: Drug: Clopidogrel; Drug: Placebo

• Registration Number: NCT01572129
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Status Verified: 2012-04
• Study First Submitted: 2012-04-03
• Study First Submitted QC: 2012-04-04
• Last Update Submitted: 2012-04-04
• Study First Posted: 2012-04-06
• Last Update Posted: 2012-04-06
• Primary Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reload	Clopidogrel	600 mg of clopidogrel loading dose 6-8 h before coronary angiogram, in addition to the chronic daily dose of 75 mg
Placebo	Placebo	Placebo arm in addition to the chronic daily dose of 75 mg

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events	30 days	Death Myocardial Infarction Target Vessel Revascularization

Secondary Outcome Measures

Name	Time	Method
Bleeding Events	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)
Grade of platelet residual reactivity	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.

Trial Locations

Locations (2)

Vito Fazzi Hospital; 🇮🇹 Lecce, Italy

Campus Bio-Medico University; 🇮🇹 Rome, Italy