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

NCT01155765 | Completed Phase 3

• 1 other identifier: PATRASCARDIOLOGY-2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis; Chronic Renal Failure

Keywords

Clopidogrel Resistance; prasugrel; Hemodialysis

Outcome Measures

Primary Outcomes (1)

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

  Day 30

Secondary Outcomes (3)

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

  Day 30

• Hemorrhage

  Day 30

• Stroke

  Day 30

Study Arms (2)

Prasugrel

EXPERIMENTAL

Prasugrel per os 10 mg/day

Drug: Prasugrel

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel per os 150 mg/day

Drug: Clopidogrel

Interventions

Prasugrel DRUG

Prasugrel 10 mg/day for 15 days

Prasugrel

Clopidogrel DRUG

Clopidogrel 150 mg/day for 15 days

Clopidogrel

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Patras University Hospital

Pátrai, Achaia, 26500, Greece

Location

Related Publications (1)

• 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.

  PMID: 35224730 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Prasugrel Hydrochloride; Clopidogrel

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 2, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 16, 2010

Record last verified: 2010-04

Locations

GR (1)