Dual Antiplatelet Therapy Tailored on the Extent of Platelet Inhibition (DANTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00774475
Recruitment Status : Unknown
Verified October 2008 by University of Florence.
Recruitment status was:  Not yet recruiting
First Posted : October 17, 2008
Last Update Posted : October 24, 2008
Tuscany Region
Information provided by:
University of Florence

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).

Condition or disease Intervention/treatment Phase
Unstable Angina NSTEMI Drug: comparison of different dosage of clopidogrel Drug: doubled therapy Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 442 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2008
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1: standard therapy
clopidogrel 75 mg/day
Drug: comparison of different dosage of clopidogrel
clopidogrel 75 mg/day versus clopidogrel 150 mg/day
Active Comparator: 2: doubled therapy
clopidogrel 150 mg/day
Drug: doubled therapy
clopidogrel 150 mg/day

Primary Outcome Measures :
  1. Incidence of MACE (cardiovascular death, nonfatal myocardial infarction, target lesion vessel revascularization by PCI or coronary bypass) [ Time Frame: 6 and 12 months ]

Secondary Outcome Measures :
  1. Stent thrombosis with angiographic confirmation; platelet function assessed by VerifyNow P2Y12 1 week after the randomization [ Time Frame: 1 week; 6 and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00774475

Contact: Gian Franco Gensini, MD 00390557949417
Contact: Rossella Marcucci, MD 00390557949420

University of Florence Not yet recruiting
Florence, Italy, 50134
Sponsors and Collaborators
University of Florence
Tuscany Region
Principal Investigator: Gian Franco Gensini, MD University of Florence
Study Chair: Gianni Maria Santoro, MD ASL 10 Florence, Italy
Study Chair: Niccolò Marchionni, MD University of Florence
Study Chair: David Antoniucci, MD Azienda Ospedaliero-Universitaria Careggi
Study Chair: Alfredo Zuppiroli, MD ASL 10 Florence Italy
Study Chair: Maria Cristina Landini, MD ASL 10 Florence Italy
Study Director: Rosanna Abbate, MD University of Florence


Responsible Party: Gian Franco Gensini, University of Florence Identifier: NCT00774475     History of Changes
Other Study ID Numbers: 000
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: October 24, 2008
Last Verified: October 2008

Keywords provided by University of Florence:
Clopidogrel therapy
platelet function inhibition

Additional relevant MeSH terms:
Angina, Unstable
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors