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

Hemodialysis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155765
• Other study ID #: PATRASCARDIOLOGY-2
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2010
• Last updated: November 15, 2010
• Start date: May 2010
• Est. completion date: July 2010

Study information

• Verified date: April 2010
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Failure
• Hemodialysis
• Kidney Failure, Chronic

Intervention

Drug:
• Prasugrel
Prasugrel 10 mg/day for 15 days
• Clopidogrel
Clopidogrel 150 mg/day for 15 days

Locations

Country	Name	City	State
Greece	Patras University Hospital	Patras	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet Reactivity Units (PRU)assessed by VerifyNow P2Y12(Accumetrics)		Day 30	No
Secondary	Major Adverse Cardiac Events (death, myocardial infarction, revascularization)		Day 30	No
Secondary	Hemorrhage		Day 30	Yes
Secondary	Stroke		Day 30	Yes