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

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.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01572129

Enrollment

240

Registered

2012-04-06

Start date

2011-11-30

Completion date

Unknown

Last updated

2012-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Myocardial Infarction

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.

Interventions

DRUGClopidogrel

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

DRUGPlacebo

Placebo in addition to the chronic daily dose of 75 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Major Adverse Cardiovascular Events	30 days	Death Myocardial Infarction Target Vessel Revascularization

Secondary

Measure	Time frame	Description
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.

Countries

Italy

Contacts

Primary ContactGiuseppe Patti, MD

g.patti@unicampus.it06225411899

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026