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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Acute Coronary Syndrome, Myocardial Infarction

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reload<br>600 mg of clopidogrel loading dose 6-8 h before coronary angiogram, in addition to the chronic daily dose of 75 mg | Drug: Clopidogrel<br>* 600 mg clopidogrel loading dose 6-8 h before diagnostic coronary angiogram<br>* Other names: Plavix;|
| Placebo Comparator: Placebo<br>Placebo arm in addition to the chronic daily dose of 75 mg | Drug: Placebo<br>* Placebo in addition to the chronic daily dose of 75 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events | Death Myocardial Infarction Target Vessel Revascularization | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |