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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Florence.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Tuscany Region
Information provided by:
University of Florence
ClinicalTrials.gov Identifier:
NCT00774475
First received: October 16, 2008
Last updated: October 23, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Unstable Angina
NSTEMI
Drug: comparison of different dosage of clopidogrel
Drug: doubled therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Florence:

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

Secondary Outcome Measures:
  • Stent thrombosis with angiographic confirmation; platelet function assessed by VerifyNow P2Y12 1 week after the randomization [ Time Frame: 1 week; 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 442
Study Start Date: November 2008
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774475

Contacts
Contact: Gian Franco Gensini, MD 00390557949417 g.gensini@dac.unifi.it
Contact: Rossella Marcucci, MD 00390557949420 rossella.marcucci@unifi.it

Locations
Italy
University of Florence Not yet recruiting
Florence, Italy, 50134
Sponsors and Collaborators
University of Florence
Tuscany Region
Investigators
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
  More Information

Publications:

Responsible Party: Gian Franco Gensini, University of Florence
ClinicalTrials.gov Identifier: NCT00774475     History of Changes
Other Study ID Numbers: 000
Study First Received: October 16, 2008
Last Updated: October 23, 2008
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Angina, Unstable
Acute Coronary Syndrome
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 26, 2014