Therapy With High Clopidogrel Dose or Prasugrel Standard Dose Reduces the Platelet Reactivity in Patients With Genotype Variation RESET GENE Trial

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Gennaro Sardella, University of Roma La Sapienza

ClinicalTrials.gov Identifier:

NCT01465828

First received: October 28, 2011

Last updated: March 24, 2012

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 28, 2011
Last Updated Date	March 24, 2012
Start Date ^ICMJE	October 2011
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 4, 2011)	antiplatelet effect of standard dose of prasugrel versus high dose clopidogrel in stable patients with HTPR [ Time Frame: 14-28 days ] [ Designated as safety issue: Yes ] The primary aim will be to investigate the antiplatelet effect of standard dose of prasugrel versus high dose clopidogrel in stable patients with HTPR while receiving chronic clopidogrel treatment at the end of the 2 study periods (switching, crossover and post-crossover)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01465828 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 4, 2011)	Bleeding (major, minor, or minimal according to the TIMI study criteria) [ Time Frame: 14-28 days ] [ Designated as safety issue: Yes ] Bleeding (major, minor, or minimal according to the TIMI study criteria) Major Adverse Cardiac Cerebrovascular Events [ Time Frame: 14-28 days ] [ Designated as safety issue: Yes ] cardiovascular death, myocardial infarction, and stroke
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Therapy With High Clopidogrel Dose or Prasugrel Standard Dose Reduces the Platelet Reactivity in Patients With Genotype Variation RESET GENE Trial
Official Title ^ICMJE	PhaRmacodynamic Effects of Switching thErapy in paTients With High on Treatment Platelet Reactivity and Genotype Variation: High Clopidogrel Dose Versus Prasugrel RESET GENE Trial
Brief Summary	Dual antiplatelet therapy with aspirin and Clopidogrel for at least one year is essential in patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) with drug eluting stent(s. Interindividual variability in platelet response to clopidogrel has been reported, with several mechanisms being implicated for high post-clopidogrel treatment PR. High on-treatment platelet reactivity (HTPR) is associated with an increased risk of adverse events after PCI. Studies in patients on chronic clopidogrel treatment are scarce, mainly in diabetic patients where HTPR is frequently present and independently predictive of adverse events. Optimization of platelet inhibition in patients with HTPR by increasing clopidogrel or alternatively, by more potent P2Y12 inhibitors is a controversial issue, mostly studied in post PCI patients, while no data exist, to the best of the investigators knowledge, in stable patients on chronic clopidogrel treatment. Therefore all HTPR patients, that will accept to participate, will be enrolled will randomize (Day 0) in a 1:1 ratio to either clopidogrel 150 mg a day, or prasugrel 10 mg a day, until Day 14 post randomization. A 14 ± 2 day visit will be performed for PR measurement and safety evaluation, with the blood sample being will be obtained 16-18 hours after the last study-drug dose, will follow by crossover directly to the alternate therapy for an additional 14 days without an intervening washout period. At Day 28 ± 2 patients will return for the clinical and laboratory assessment as did on Day 14 visit.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Acute Coronary Syndrome
Intervention ^ICMJE	Drug: Clopidogrel Patient will be randomized to this intervention will receive in the first time the high clopidogrel dose and after 14 days we will change their therapy with standard dose of prasugrel (crossover). Drug: prasugrel Patient will be randomized to this intervention will receive in the first time the standard dose of prasugrel and after 14 days we will change their therapy with high dose of clopidogrel (crossover).
Study Arm (s)	Active Comparator: high clopidogrel dose Patients will be randomized to this arm to receive before high clopidogrel dose and after crossover they will receive standard dose of prasugrel Interventions: Drug: Clopidogrel Drug: prasugrel No Intervention: prasugrel standard dose Patients will be randomized to this arm to receive before standard dose of prasugrel and after crossover they will receive high clopidogrel dose.
Publications *	Sardella G, Calcagno S, Mancone M, Palmirotta R, Lucisano L, Canali E, Stio RE, Pennacchi M, Di Roma A, Benedetti G, Guadagni F, Biondi-Zoccai G, Fedele F. Pharmacodynamic effect of switching therapy in patients with high on-treatment platelet reactivity and genotype variation with high clopidogrel Dose versus prasugrel: the RESET GENE trial. Circ Cardiovasc Interv. 2012 Oct;5(5):698-704. doi: 10.1161/CIRCINTERVENTIONS.112.972463. Epub 2012 Oct 9.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date	January 2012
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: patients underwent to PCI lopidogrel resistance after Platelet reactivity blood test 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 contraindication for prasugrel administration patients weighing <60 kg >75 years of age.
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01465828
Other Study ID Numbers ^ICMJE	RESET GENE
Has Data Monitoring Committee	Yes
Responsible Party	Gennaro Sardella, University of Roma La Sapienza
Study Sponsor ^ICMJE	Gennaro Sardella
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Roma La Sapienza
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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