Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis

NCT ID: NCT01511471

Last Updated: 2012-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-02-29

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ticagrelor

Ticagrelor 90mg twice a day for 15 days

Group Type: EXPERIMENTAL

Ticagrelor

Intervention Type: DRUG

Ticagrelor 90mg twice a day for 15 days

Interventions

Ticagrelor

Ticagrelor 90mg twice a day for 15 days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Patras

OTHER

Sponsor Role: lead

Responsible Party

Dimitrios Alexopoulos

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Agios Andreas General Hospital, Nephrology Department

Pátrai, Achaia, Greece

Cardiology Department Patras University Hospital

Rio, Achaia, Greece

Countries

Greece

Other Identifiers

PATRASCARDIOLOGY-9

Identifier Type: -

Identifier Source: org_study_id