Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis
This study has been completed.
Sponsor:
University of Patras
Information provided by:
University of Patras
ClinicalTrials.gov Identifier:
NCT01155765
First received: July 1, 2010
Last updated: November 15, 2010
Last verified: April 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemodialysis Chronic Renal Failure |
Drug: Prasugrel Drug: Clopidogrel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Patras:
Primary Outcome Measures:
- Platelet Reactivity Units (PRU)assessed by VerifyNow P2Y12(Accumetrics) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 70 |
| Study Start Date: | May 2010 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Prasugrel
Prasugrel per os 10 mg/day
|
Drug: Prasugrel
Prasugrel 10 mg/day for 15 days
|
|
Active Comparator: Clopidogrel
Clopidogrel per os 150 mg/day
|
Drug: Clopidogrel
Clopidogrel 150 mg/day for 15 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dimitrios Alexopoulos, Patras University Hospital |
| ClinicalTrials.gov Identifier: | NCT01155765 History of Changes |
| Other Study ID Numbers: | PATRASCARDIOLOGY-2 |
| Study First Received: | July 1, 2010 |
| Last Updated: | November 15, 2010 |
| Health Authority: | Greece: Ethics Committee |
Keywords provided by University of Patras:
|
Clopidogrel Resistance prasugrel Hemodialysis |
Additional relevant MeSH terms:
|
Kidney Failure, Chronic Renal Insufficiency Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases Clopidogrel Ticlopidine Prasugrel Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses |
Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013