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

Information source: University of Roma La Sapienza
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: Clopidogrel (Drug); Prasugrel (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Gennaro Sardella

Overall contact:
Gennaro Sardella, MD, Phone: +390649979035, Email: rino.sardella@uniroma1.it


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.

Clinical Details

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

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

Primary outcome: superiority of prasugrel low dose

Secondary outcome:


major adverse cardiac events


Minimum age: 75 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Gennaro Sardella, MD, Phone: +390649979035, Email: rino.sardella@uniroma1.it

Dept.of Cardiovascular Sciences,Policlinico Umberto I, Rome 000161, Italy; Not yet recruiting
Rocco Stio, MD, Phone: +300649979046, Email: rocco.stio@libero.it
Additional Information

Starting date: March 2013
Last updated: January 24, 2013

Page last updated: August 23, 2015

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