Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis

This study has been completed.

Sponsor:

Information provided by:

University of Patras

ClinicalTrials.gov Identifier:

NCT01155765

First received: July 1, 2010

Last updated: November 15, 2010

Last verified: April 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	July 1, 2010
Last Updated Date	November 15, 2010
Start Date ^ICMJE	May 2010
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 1, 2010)	Platelet Reactivity Units (PRU)assessed by VerifyNow P2Y12(Accumetrics) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01155765 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 1, 2010)	Major Adverse Cardiac Events (death, myocardial infarction, revascularization) [ Time Frame: Day 30 ] [ Designated as safety issue: No ] Hemorrhage [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ] Stroke [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
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	Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis
Official Title ^ICMJE	Prasugrel in Comparison to High Clopidogrel Dose for Inhibition of Platelet Reactivity as Assessed With a Point-of-Care Platelet Function Assay in Patients Undergoing Chronic Hemodialysis Presenting Resistance to the Usual Clopidogrel Dose
Brief Summary	Clopidogrel administration is essential in patients undergoing percutaneous coronary intervention, in patients with previous stroke, in patients under chronic hemodialysis via fistulae and in patients with chronic atrial fibrillation if coumarin administration is not a viable option. Patients with chronic renal failure present lower clopidogrel response compared to those with normal renal function. Additionally, hemodialysis via the dialysis filter causes a decrease in glycoprotein platelet receptors, potentially associated with thienopyridine hyporesponsiveness. Clopidogrel resistant patients as assessed by VerifyNow P2Y12(Accumetrics)will be randomized in 1:1 fashion to prasugrel 10mg/day or clopidogrel 150mg/day. On day 15±2 days a crossover directly to the alternate treatment group will be carried out, without an interventing washout period. All patients will undergo platelet reactivity assessment, documentation of major adverse cardiac events and documentation of any serious adverse events(stroke, bleeding)at day 15 and day 30.
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	Hemodialysis Chronic Renal Failure
Intervention ^ICMJE	Drug: Prasugrel Prasugrel 10 mg/day for 15 days Drug: Clopidogrel Clopidogrel 150 mg/day for 15 days
Study Arm (s)	Experimental: Prasugrel Prasugrel per os 10 mg/day Intervention: Drug: Prasugrel Active Comparator: Clopidogrel Clopidogrel per os 150 mg/day Intervention: Drug: Clopidogrel
Publications *	Not Provided
* 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 History of chronic renal failure under hemodialysis for at least 6 months Under clopidogrel 75mg/day treatment for at least 7 days before randomization Informed consent obtained in writing Exclusion Criteria: Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit. Pregnancy Breastfeeding Inability to give informed consent or high likelihood of being unavailable for the Day 30 follow up. Malignancy Acute coronary syndrome or hemodynamic instability within 30 days prior to randomization Requirement for oral anticoagulant prior to the Day 30 visit Requirement for discontinuation of thienopyridine treatment prior to the Day 30 visit Treatment with IIb/IIIa inhibitors within 30 days prior to randomization or planned administration prior to the Day 30 visit Known hypersensitivity to prasugrel or clopidogrel. History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months. Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on thienopyridine therapy. Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm). Thrombocytopenia (<100.000 / μL) at randomization Known liver failure (bilirubin > 2mg/dl)
Gender	Both
Ages	18 Years to 85 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	NCT01155765
Other Study ID Numbers ^ICMJE	PATRASCARDIOLOGY-2
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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