Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis

Platelet Reactivity Clinical Trial

Official title:

Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511471
• Other study ID #: PATRASCARDIOLOGY-9
• Status: Completed
• Phase: Phase 3
• First received: January 12, 2012
• Last updated: February 2, 2012
• Start date: January 2012
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age=18 years

• Chronic renal failure under haemodialysis

• Platelet reactivity under clopidogrel 75mgx1 =235 PRU

• Informed written consent

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Platelet Reactivity

Intervention

Drug:
• Ticagrelor
Ticagrelor 90mg twice a day for 15 days

Locations

Country	Name	City	State
Greece	Agios Andreas General Hospital, Nephrology Department	Patras	Achaia
Greece	Cardiology Department Patras University Hospital	Rio	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 assessed by VerifyNow P2Y12 assay		Day 15	No
Secondary	Bleeding events according to TIMI criteria	Major, minor or minimal bleeding events according to TIMI criteria	Day 15	Yes
Secondary	Major adverse cardiovascular events	Death, non-fatal myocardial infarction and stroke	Day 15	Yes