Standard Clopidogrel Versus Prasugrel Low Dose Therapy in Elderly Patients With Acute Coronary Syndrome

Coronary Artery Disease Clinical Trial

— RESET ELDERLY  

Official title:

PhaRmacodynamic Effect of Antiplatelet Agents in Elderly Patients: Standard Clopidogrel Versus prasugrEl Low Dose Therapy.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01778842
• Other study ID #: RESET ELDERLY
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 24, 2013
• Last updated: January 24, 2013
• Start date: March 2013
• Est. completion date: July 2013

Study information

• Verified date: January 2013
• Source: University of Roma La Sapienza
• Contact: Gennaro Sardella, MD
• Phone: +390649979035
• Email: rino.sardella[@]uniroma1.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Dept.of Cardiovascular Sciences,Policlinico Umberto I	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Gennaro Sardella

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	superiority of prasugrel low dose	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.	30 days	Yes
Secondary	Bleeding	Bleeding (major, minor, or minimal according to the TIMI study criteria)	12 months	Yes
Secondary	major adverse cardiac events	major adverse cardiac events (cardiovascular death, myocardial infarction, and stroke) will be evaluated during the all period of treatment.	12 months	Yes