Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Post Percutaneous Coronary Intervention (PCI).

This study has been completed.

Sponsor:

Information provided by:

University of Patras

ClinicalTrials.gov Identifier:

NCT01109784

First received: April 22, 2010

Last updated: August 23, 2010

Last verified: April 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	April 22, 2010
Last Updated Date	August 23, 2010
Start Date ^ICMJE	April 2010
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 26, 2010)	Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics) [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: April 22, 2010)	PRU assessed by VerifyNow P2Y12(Accumetrics) [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01109784 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Post Percutaneous Coronary Intervention (PCI).
Official Title ^ICMJE	Phase 3 Study of Prasugrel vs High Dose (150 mg) Clopidogrel in Clopidogrel Resistant Patients Post Coronary Angioplasty.
Brief Summary	The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events. Additionally, clopidogrel resistance has been linked with the CYP2C19 polymorphism. The hypothesis of the study is to define in consecutive patients undergoing PCI those that are clopidogrel resistant PCI following routinely used loading as estimated predischarge with the VerifyNow point of care system of platelet reactivity. Clopidogrel resistant patients will be randomized in 1:1 fashion to prasugrel 10 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 30, when treatment crossover will be performed. At day 60 platelet reactivity will be determined as well. In addition, in all patients genetic determination of CYP polymorphisms (including the CYP2C19)known to affect clopidogrel metabolism will be performed.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Coronary Artery Disease (CAD) Acute Coronary Syndrome (ACS)
Intervention ^ICMJE	Drug: prasugrel prasugrel 10 mg/day Drug: clopidogrel clopidogrel per os 150mg/day
Study Arm (s)	Experimental: prasugrel prasugrel per os 10mg/day Intervention: Drug: prasugrel Active Comparator: clopidogrel clopidogrel per os 150mg/day Intervention: Drug: clopidogrel
Publications *	Alexopoulos D, Dimitropoulos G, Davlouros P, Xanthopoulou I, Kassimis G, Stavrou EF, Hahalis G, Athanassiadou A. Prasugrel overcomes high on-clopidogrel platelet reactivity post-stenting more effectively than high-dose (150-mg) clopidogrel: the importance of CYP2C19*2 genotyping. JACC Cardiovasc Interv. 2011 Apr;4(4):403-10.
* 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
Estimated Enrollment ^ICMJE	70
Completion Date	July 2010
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age ≥18 years old Patients having PCI with stenting 24-48 hours prior randomization, for 1. Stable angina 2.Ischaemia in provocative test 3.Acute coronary syndrome (unstable angina or myocardial infarction) Written Informed consent Platelet reactivity units (PRU) (VerifyNow) >230 Exclusion Criteria: A history of bleeding diathesis Chronic oral anticoagulation treatment Contraindications to antiplatelet therapy Known platelet function disorders PCI or coronary artery bypass surgery < 3 months Unsuccessful PCI (residual stenosis > 30% or flow < Thrombolysis in myocardial infarction flow 3) Planned staged PCI in the next 60 days Hemodynamic instability Cancer or hemodialysis Platelet count <100 000/ μL, hematocrit <30% Creatinine clearance <25 ml/min A life expectancy<1 year, inability to give informed consent High likelihood of being unavailable for the Day 60 follow up
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Greece

Administrative Information
NCT Number ^ICMJE	NCT01109784
Other Study ID Numbers ^ICMJE	PATRASCARDIOLOGY-1
Has Data Monitoring Committee	No
Responsible Party	Dimitrios Alexopoulos, Patras University Hospital
Study Sponsor ^ICMJE	University of Patras
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Patras
Verification Date	April 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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