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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01511471
Other study ID # PATRASCARDIOLOGY-9
Secondary ID
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


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
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