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Standard Clopidogrel Versus Prasugrel Low Dose Therapy in Elderly Patients With Acute Coronary Syndrome (RESET ELDERLY)

This study is not yet open for participant recruitment.
Verified January 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Gennaro Sardella, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01778842
First received: January 24, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

The elderly represent a growing segment of the coronary population treated by dual antiplatelet therapy for percutaneous coronary intervention (PCI). These patients bear a higher risk of both ischemic events and bleeding complications than younger patients, with a subsequently higher rate of mortality.Recentprogress in antithrombotic treatment demonstrated the efficacy of adding a P2Y12 receptor antagonist to low-dose aspirin. Whether this benefit is also present in the elderly remains a debated issue due to the lack of specific data in this sub-population. The present study was realized to provide specific data on platelet response to clopidogrel, standard dose (75 mg) or prasugrel 5 mg in elderly patients (≥75 years old) whereas the superiority in PR response of the latter should allows the Prasugrel therapy in elderly patients with the better clinical efficacy and therapeutical safety already showed compared with Clopidogrel.


Condition Intervention Phase
Coronary Artery Disease
 Drug: Clopidogrel
Drug: Prasugrel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PhaRmacodynamic Effect of Antiplatelet Agents in Elderly Patients: Standard Clopidogrel Versus prasugrEl Low Dose Therapy.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • superiority of prasugrel low dose [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    The primary aim will be to investigate the antiplatelet effect of half dose of prasugrel (5 mg) versus standard dose of clopidogrel in patients with acute coronary syndrome and coronary diseases, treated with percutaneous coronary intervention and stent implantation.


Secondary Outcome Measures:
  • Bleeding [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Bleeding (major, minor, or minimal according to the TIMI study criteria)

  • major adverse cardiac events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    major adverse cardiac events (cardiovascular death, myocardial infarction, and stroke) will be evaluated during the all period of treatment.


Estimated Enrollment: 68
Study Start Date: March 2013
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prasugrel low dose
Patient will be randomized to this intervention will receive prasugrel 5 mg and after 15 days and 30 days we will control the responsivness of the study drug.
 Drug: Prasugrel
Patient will be randomized to this intervention will receive the low dose of prasugrel and after 15 days and 30 days we will control the responsivness of the study drug.
Experimental: Clopidogrel standard dose
Patient will be randomized to this intervention will receive clopidogrel 75 mg and after 15 days and 30 days we will control the responsivness of the study drug.
 Drug: Clopidogrel
Patient will be randomized to this intervention will receive the standard dose of clopidogrel and after 15 days and 30 days we will control the responsivness of the study drug.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute coronary syndrome
  • PCI with stent implantation
  • clopidogrel responsiveness
  • > 75 years of age.

Exclusion Criteria:

  • history of bleeding diathesis
  • chronic oral anticoagulation treatment
  • contraindications to antiplatelet therapy
  • PCI or coronary artery bypass grafting (CABG) < 3 months
  • hemodynamic instability
  • platelet count < 100,000/μl
  • hematocrit < 30%
  • creatinine clearance < 25 ml/min
  • Patients with a history of stroke
  • other contraindication for prasugrel administration
  • patients weighing < 60 kg
  • high on treatment platelet reactivity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778842

Contacts
Contact: Gennaro Sardella, MD +390649979035 rino.sardella@uniroma1.it

Locations
Italy
Dept.of Cardiovascular Sciences,Policlinico Umberto I Not yet recruiting
Rome, Italy, 000161
Contact: Rocco Stio, MD     +300649979046     rocco.stio@libero.it    
Sponsors and Collaborators
Gennaro Sardella
  More Information

No publications provided

Responsible Party: Gennaro Sardella, Associate Professor in Cardiology, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01778842     History of Changes
Other Study ID Numbers: RESET ELDERLY
Study First Received: January 24, 2013
Last Updated: January 24, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
antiplatelet effect
prasugrel
clopidogrel
acute coronary syndrome

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Platelet Aggregation Inhibitors
 Ticlopidine
Prasugrel
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 June 13, 2013