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

NCT ID: NCT01155765

Last Updated: 2010-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-07-31

Brief Summary

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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

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Conditions

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Hemodialysis Chronic Renal Failure

Keywords

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Clopidogrel Resistance prasugrel Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Prasugrel

Prasugrel per os 10 mg/day

Group Type EXPERIMENTAL

Prasugrel

Intervention Type DRUG

Prasugrel 10 mg/day for 15 days

Clopidogrel

Clopidogrel per os 150 mg/day

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Clopidogrel 150 mg/day for 15 days

Interventions

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Prasugrel

Prasugrel 10 mg/day for 15 days

Intervention Type DRUG

Clopidogrel

Clopidogrel 150 mg/day for 15 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years old
2. History of chronic renal failure under hemodialysis for at least 6 months
3. Under clopidogrel 75mg/day treatment for at least 7 days before randomization
4. Informed consent obtained in writing

Exclusion Criteria

1. 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.
2. Pregnancy
3. Breastfeeding
4. Inability to give informed consent or high likelihood of being unavailable for the Day 30 follow up.
5. Malignancy
6. Acute coronary syndrome or hemodynamic instability within 30 days prior to randomization
7. Requirement for oral anticoagulant prior to the Day 30 visit
8. Requirement for discontinuation of thienopyridine treatment prior to the Day 30 visit
9. Treatment with IIb/IIIa inhibitors within 30 days prior to randomization or planned administration prior to the Day 30 visit
10. Known hypersensitivity to prasugrel or clopidogrel.
11. History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
12. Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on thienopyridine therapy.
13. Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
14. Thrombocytopenia (\<100.000 / μL) at randomization
15. Known liver failure (bilirubin \> 2mg/dl)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Patras

OTHER

Sponsor Role lead

Responsible Party

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Patras University Hospital

Locations

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Patras University Hospital

Pátrai, Achaia, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 35224730 (View on PubMed)

Other Identifiers

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PATRASCARDIOLOGY-2

Identifier Type: -

Identifier Source: org_study_id