Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis

• Sponsor: University of Patras (Other)
• Overall Status: Completed
• CT.gov ID: NCT01511471
• Collaborator: (none)
• Enrollment: 20
• Locations: 2
• Arm: 1
• Duration (Months): 1
• Patients Per Site: 10
• Patients Per Site Per Month: 9.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Platelet Reactivity	Drug: Ticagrelor	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ticagrelor Ticagrelor 90mg twice a day for 15 days	Drug: Ticagrelor; Ticagrelor 90mg twice a day for 15 days

Outcome Measures

Primary Outcome Measures

1. Platelet reactivity assessed by VerifyNow P2Y12 assay [Day 15]

Secondary Outcome Measures

1. Bleeding events according to TIMI criteria [Day 15]

   Major, minor or minimal bleeding events according to TIMI criteria

2. Major adverse cardiovascular events [Day 15]

   Death, non-fatal myocardial infarction and stroke

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Agios Andreas General Hospital, Nephrology Department	Patras	Achaia	Greece	26500
2	Cardiology Department Patras University Hospital	Rio	Achaia	Greece	26500

Sponsors and Collaborators

• University of Patras

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dimitrios Alexopoulos, Clinical Professor, University of Patras
• ClinicalTrials.gov Identifier: NCT01511471
• Other Study ID Numbers: PATRASCARDIOLOGY-9
• First Posted: Jan 18, 2012
• Last Update Posted: Feb 3, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Dimitrios Alexopoulos, Clinical Professor, University of Patras: Ticagrelor; platelet reactivity; clopidogrel; haemodialysis
• Additional relevant MeSH terms: Ticagrelor

Study Results

No Results Posted as of Feb 3, 2012