Return of platelet function following cessation of oral anti-platelet treatment with ticagrelor
Conditions
Interventions
Trade Name: Brilique
Pharmaceutical Form: Tablet
Other descriptive name: TICAGRELOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Sponsors
Universitetssjukhuset Örebro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 12 months (+/- one week) treatment with double platelet blockade in the form of ASA and ticagrelor following PCI 2. Age = 45 years 3. Signed and dated Informed Consent 4. The subject is willing and judged capable of following the protocol throughout the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Resistance against ticagrelor treatment (so-called “non-responders”) 2. Other oral anti-platelets agents other than ticagrelor 180 mg and ASA 75 mg/day 3. Concurrent treatment with fluvoxamine, fluoxetine, moklobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxkarbazepine or chloramphenicol. 4. Oversensitivity/allergy to ticagrelor 5. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: How does cessation of ticagrelor treatment influence the ability of platelet aggregation?;Secondary Objective: Can cessation of ticagrelor treatment influence total blood coagulability and could this determine the time to start of safe surgery? Which method used to determine residuel effects of ticagrelor on platelet aggregation is most sensitive?;Primary end point(s): Number of days following cessation of ticagrelor treatment that the platelet function is back to normal (< 20 % residual effect ) measured with platelet inhibition test (Verify Now Aggregometry).;Timepoint(s) of evaluation of this end point: Blood sampling before the last treatment (- day 3 to day 0 = last day of treatment) and day 1, 3, 5, 8 and 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Influence on whole blood coagulation measured with thrombelastography when the platelet inhibition is > 45 units. 2. Which method is the most sensitive for measuring platelet inhibition following cessation of ticagrelor treatment: Multiplate” or VerifyNow?;Timepoint(s) of evaluation of this end point: Blood sampling before the last treatment (day - 3 to day 0 = last day of treatment) and day 1, 3, 5, 8 and 10.</ | — |
Countries
Sweden
Contacts
Public ContactANIVA-kliniken, USÖ
Universitetssjukhuset Örebro, USÖ
Outcome results
None listed