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

Primary Purpose

Hemodialysis, Chronic Renal Failure

Status

Completed

Phase

Phase 3

Locations

Greece

Study Type

Interventional

Intervention

Prasugrel

Clopidogrel

About this trial

This is an interventional treatment trial for Hemodialysis focused on measuring Clopidogrel Resistance, prasugrel, Hemodialysis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Patras University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prasugrel

Clopidogrel

Arm Description

Prasugrel per os 10 mg/day

Clopidogrel per os 150 mg/day

Outcomes

Primary Outcome Measures

Platelet Reactivity Units (PRU)assessed by VerifyNow P2Y12(Accumetrics)

Secondary Outcome Measures

Major Adverse Cardiac Events (death, myocardial infarction, revascularization)

Hemorrhage

Stroke

Full Information

NCT ID

NCT01155765

First Posted

July 1, 2010

Last Updated

November 15, 2010

Sponsor

University of Patras

1. Study Identification

Unique Protocol Identification Number

NCT01155765

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Patras

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemodialysis, Chronic Renal Failure

Keywords

Clopidogrel Resistance, prasugrel, Hemodialysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prasugrel

Arm Type

Experimental

Arm Description

Prasugrel per os 10 mg/day

Arm Title

Clopidogrel

Arm Type

Active Comparator

Arm Description

Clopidogrel per os 150 mg/day

Intervention Type

Drug

Intervention Name(s)

Prasugrel

Intervention Description

Prasugrel 10 mg/day for 15 days

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Intervention Description

Clopidogrel 150 mg/day for 15 days

Primary Outcome Measure Information:

Title

Platelet Reactivity Units (PRU)assessed by VerifyNow P2Y12(Accumetrics)

Time Frame

Day 30

Secondary Outcome Measure Information:

Title

Major Adverse Cardiac Events (death, myocardial infarction, revascularization)

Time Frame

Day 30

Title

Hemorrhage

Time Frame

Day 30

Title

Stroke

Time Frame

Day 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

Patras University Hospital

City

Patras

State/Province

Achaia

ZIP/Postal Code

26500

Country

Greece

12. IPD Sharing Statement

Citations:

PubMed Identifier

35224730

Citation

Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

Results Reference

derived

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

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