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Dual Antiplatelet Therapy Tailored on the Extent of Platelet Inhibition

Optimization of Antiplatelet Therapy With Clopidogrel on the Basis of the Extent of Platelet Inhibition in Patients With Acute Coronary Syndromes on Dual Antiplatelet Therapy Undergoing PCI With Stent Implantation

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00774475
Acronym
DANTE
Enrollment
442
Registered
2008-10-17
Start date
2008-11-30
Completion date
2011-01-31
Last updated
2008-10-24

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

Conditions

NSTEMI, Unstable Angina

Keywords

Clopidogrel therapy, platelet function inhibition

Brief summary

The purpose of this study is to evaluate the efficacy (reduction of major ischemic events at 6 and 12 months of follow-up) of a tailored clopidogrel therapy in patients with UA/NSTEMI undergoing PCI with stent implantation and wiht a documented residual platelet reactivity assessed by a point of care system (VerifyNow P2Y12).

Detailed description

Several studies documented the presence of a high variability in the individual response to antiplatelet therapies in terms of extent of platelet function inhibition. This laboratory finding is the so-called aspirin or clopidogrel resistance which we prefer to define residual platelet reactivity (RPR) on antiplatelet therapy. A growing body of evidence is demonstrating the clinical relevance of this laboratory parameter, i.e. patients with RPR are at higher risk of a subsequent adverse cardiovascular event. In particular, it has been demonstrated that RPR measured by light transmittance aggregometry induced by ADP or by the point of care assay VerifyNow P2Y12 identifies patients which, after coronary revascularization with stent implantation, at higher risk of a potentially catastrophic event such as stent thrombosis. No randomized trials are available in the literature on the efficacy and safety of an antiplatelet therapy tailored on the extent of platelet function inhibition.

Interventions

DRUGcomparison of different dosage of clopidogrel

clopidogrel 75 mg/day versus clopidogrel 150 mg/day

DRUGdoubled therapy

clopidogrel 150 mg/day

Sponsors

Tuscany Region
CollaboratorUNKNOWN
University of Florence
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Unstable or NSTEMI

Exclusion criteria

Previous bleeding events which have required blood transfusion * PT- INR \>1.5 * Platelet count ≤ 100000/ mm3 * Hb \< 10 g/dl * Previous TIA/stroke (ischemic or hemorrhagic or unknown) * Body weight \< 60 Kg * Creatinine levels ≥ 4 mg/dl * Cerebral neoplasia * Recent major trauma/surgery/head injury (within 3 previous weeks) * Gastrointestinal hemorrhage in the last month * Aortic dissection * Known haemorrhagic diathesis * Oral anticoagulant therapy * Pregnancy or 1 week after delivery * Uncontrolled hypertension (systolic \>180 mmHg or diastolic \>110 mmHg) * Severe liver disease * Infective endocarditis * Major psychiatric disorders * Alcool or drug abuse * Active peptic ulcer Noncompressible arterial puncture within 14 days Prolonged cardiopulmonary resuscitation

Design outcomes

Primary

MeasureTime frame
Incidence of MACE (cardiovascular death, nonfatal myocardial infarction, target lesion vessel revascularization by PCI or coronary bypass)6 and 12 months

Secondary

MeasureTime frame
Stent thrombosis with angiographic confirmation; platelet function assessed by VerifyNow P2Y12 1 week after the randomization1 week; 6 and 12 months

Countries

Italy

Contacts

Primary ContactGian Franco Gensini, MD
g.gensini@dac.unifi.it00390557949417
Backup ContactRossella Marcucci, MD
rossella.marcucci@unifi.it00390557949420

Outcome results

None listed

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