Standard Clopidogrel Versus Prasugrel Low Dose Therapy in Elderly Patients With Acute Coronary Syndrome (RESET ELDERLY)
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|ClinicalTrials.gov Identifier: NCT01778842|
Recruitment Status : Unknown
Verified January 2013 by Gennaro Sardella, University of Roma La Sapienza.
Recruitment status was: Not yet recruiting
First Posted : January 29, 2013
Last Update Posted : January 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Clopidogrel Drug: Prasugrel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PhaRmacodynamic Effect of Antiplatelet Agents in Elderly Patients: Standard Clopidogrel Versus prasugrEl Low Dose Therapy.|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||July 2013|
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.
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.
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.
- superiority of prasugrel low dose [ Time Frame: 30 days ]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.
- Bleeding [ Time Frame: 12 months ]Bleeding (major, minor, or minimal according to the TIMI study criteria)
- major adverse cardiac events [ Time Frame: 12 months ]major adverse cardiac events (cardiovascular death, myocardial infarction, and stroke) will be evaluated during the all period of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778842
|Contact: Gennaro Sardella, MDfirstname.lastname@example.org|
|Dept.of Cardiovascular Sciences,Policlinico Umberto I||Not yet recruiting|
|Rome, Italy, 000161|
|Contact: Rocco Stio, MD +300649979046 email@example.com|