Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis

NCT01511471 | Completed Phase 3

• 1 other identifier: PATRASCARDIOLOGY-9
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Clopidogrel administration is commonly prescribed in patients undergoing percutaneous coronary intervention, in patients with previous stroke and in patients under chronic hemodialysis via fistulae. Patients with chronic renal failure present lower clopidogrel response compared to those with normal renal function. Ticagrelor is a new oral direct-acting antagonist, which provides greater platelet inhibition in both clopidogrel responders and non-responders. It has also been shown that in patients with chronic kidney disease (creatinine clearance \<60 mL/min)ticagrelor achieved an absolute risk reduction of cardiovascular death, myocardial infarction, and stroke greater than that of patients with normal renal function. Clopidogrel resistant patients as assessed by VerifyNow P2Y12(Accumetrics)will be administered after informed consent ticagrelor 90 mg twice daily for 15 days. Platelet reactivity will be determined at the end of the treatment period. Bleeding events, major adverse cardiac events and any side effects until Day 15 will be reported in a descriptive manner.

Conditions

Platelet Reactivity

Keywords

Ticagrelor; platelet reactivity; clopidogrel; haemodialysis

Outcome Measures

Primary Outcomes (1)

• Platelet reactivity assessed by VerifyNow P2Y12 assay

  Day 15

Secondary Outcomes (2)

• Bleeding events according to TIMI criteria

  Day 15

• Major adverse cardiovascular events

  Day 15

Study Arms (1)

Ticagrelor

EXPERIMENTAL

Ticagrelor 90mg twice a day for 15 days

Drug: Ticagrelor

Interventions

Ticagrelor DRUG

Ticagrelor 90mg twice a day for 15 days

Ticagrelor

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 years
• Chronic renal failure under haemodialysis
• Platelet reactivity under clopidogrel 75mgx1 ≥235 PRU
• Informed written consent

You may not qualify if:

• Recent (within 1 month) PCI or ACS
• Requirement for oral anticoagulant prior to the Day 14 visit
• PLTs\<100.000 / μL), Hct \<28%, Hct \> 52% at randomization
• Increased risk of bradycardiac events.
• Severe uncontrolled chronic obstructive pulmonary disease
• Known severe hepatic impairment
• 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
• Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
• Recent (\<6weeks)major surgery including CABG
• Recent (\<6weeks)stroke or any prior intracranial bleeding

Sponsors & Collaborators

• University of Patras: lead

Study Sites (2)

Agios Andreas General Hospital, Nephrology Department

Pátrai, Achaia, 26500, Greece

Location

Cardiology Department Patras University Hospital

Rio, Achaia, 26500, Greece

Location

MeSH Terms

Interventions

Ticagrelor

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 18, 2012
• Study Start: January 1, 2012
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 3, 2012

Record last verified: 2012-02

Locations

GR (2)