Dual Antiplatelet Therapy Tailored on the Extent of Platelet Inhibition

NCT00774475 | Unknown Phase 3

• 1 other identifier: 000
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 1

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).

Conditions

Unstable Angina; NSTEMI

Keywords

Clopidogrel therapy; platelet function inhibition

Outcome Measures

Primary Outcomes (1)

• Incidence of MACE (cardiovascular death, nonfatal myocardial infarction, target lesion vessel revascularization by PCI or coronary bypass)

  6 and 12 months

Secondary Outcomes (1)

• Stent thrombosis with angiographic confirmation; platelet function assessed by VerifyNow P2Y12 1 week after the randomization

  1 week; 6 and 12 months

Study Arms (2)

1: standard therapy

PLACEBO COMPARATOR

clopidogrel 75 mg/day

Drug: comparison of different dosage of clopidogrel

2: doubled therapy

ACTIVE COMPARATOR

clopidogrel 150 mg/day

Drug: doubled therapy

Interventions

comparison of different dosage of clopidogrel DRUG

clopidogrel 75 mg/day versus clopidogrel 150 mg/day

1: standard therapy

doubled therapy DRUG

clopidogrel 150 mg/day

2: doubled therapy

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unstable or NSTEMI

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florence: lead
• Tuscany Region: collaborator

Study Sites (1)

University of Florence

Florence, 50134, Italy

Location

Related Publications (5)

• Gori AM, Marcucci R, Migliorini A, Valenti R, Moschi G, Paniccia R, Buonamici P, Gensini GF, Vergara R, Abbate R, Antoniucci D. Incidence and clinical impact of dual nonresponsiveness to aspirin and clopidogrel in patients with drug-eluting stents. J Am Coll Cardiol. 2008 Aug 26;52(9):734-9. doi: 10.1016/j.jacc.2008.05.032.

  PMID: 18718420 BACKGROUND

• Buonamici P, Marcucci R, Migliorini A, Gensini GF, Santini A, Paniccia R, Moschi G, Gori AM, Abbate R, Antoniucci D. Impact of platelet reactivity after clopidogrel administration on drug-eluting stent thrombosis. J Am Coll Cardiol. 2007 Jun 19;49(24):2312-7. doi: 10.1016/j.jacc.2007.01.094. Epub 2007 Jun 4.

  PMID: 17572245 BACKGROUND

• Price MJ, Endemann S, Gollapudi RR, Valencia R, Stinis CT, Levisay JP, Ernst A, Sawhney NS, Schatz RA, Teirstein PS. Prognostic significance of post-clopidogrel platelet reactivity assessed by a point-of-care assay on thrombotic events after drug-eluting stent implantation. Eur Heart J. 2008 Apr;29(8):992-1000. doi: 10.1093/eurheartj/ehn046. Epub 2008 Feb 10.

  PMID: 18263931 BACKGROUND

• Santoro GM, Carrabba N, Barchielli A, Balzi D, Marchionni N, Filice M, Valente S, Granelli M, Berni I, Buiatti E; AMI-Florence Working Group. Use and efficacy of abciximab in an unselected population with acute myocardial infarction treated with primary angioplasty: data from AMI-Florence registry. Atherosclerosis. 2007 Nov;195(1):116-21. doi: 10.1016/j.atherosclerosis.2006.08.053. Epub 2006 Sep 25.

  PMID: 16997308 BACKGROUND

• Balzi D, Barchielli A, Buiatti E, Franceschini C, Lavecchia R, Monami M, Santoro GM, Carrabba N, Margheri M, Olivotto I, Gensini GF, Marchionni N; AMI-Florence Working Group. Effect of comorbidity on coronary reperfusion strategy and long-term mortality after acute myocardial infarction. Am Heart J. 2006 May;151(5):1094-1100. doi: 10.1016/j.ahj.2005.06.037.

  PMID: 16644342 BACKGROUND

MeSH Terms

Conditions

Angina, Unstable; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Gian Franco Gensini, MD

  University of Florence

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Rosanna Abbate, MD

  University of Florence

  STUDY DIRECTOR

Central Study Contacts

Gian Franco Gensini, MD

CONTACT

00390557949417; g.gensini@dac.unifi.it

Rossella Marcucci, MD

CONTACT

00390557949420; rossella.marcucci@unifi.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: January 1, 2011
• Last Updated: October 24, 2008

Record last verified: 2008-10

Locations

IT (1)