ST Elevation Myocardial Infarction Clinical Trial
Official title:
OraL Crushed and dIspersed Ticagrelor 180mg Compared to Whole Tablets of eQUal Dose in STEMI Patients unDergoing Primary PCI: a Pharmacokinetic/Pharmacodynamic Study
This is a single-center, prospective, randomized, single-blind, investigator initiated,
pharmacokinetic/pharmacodynamic study of parallel design.Patients with ST elevation
myocardial infarction (symptom onset<12 hours), undergoing primary percutaneous coronary
intervention, who are P2Y12 inhibitor naïve, will be randomized after informed consent,
immediately after diagnostic coronary angiography, in a 1:1 ratio to either:
- Ticagrelor 180mg loading dose, in the form of 2 whole tablets administered per os in
the supine position (standard administration)
- Ticagrelor 180mg loading dose, in the form of 2 tablets crushed and dispersed in
purified water and administered per os with 1-minute-stay in a 60-70 degrees
semi-upright sitting position Platelet reactivity assessment will be performed at
randomization (Hour 0) and at 0.5, 1, 2, 4 and 6 hours after randomization, using the
VerifyNow assay, in platelet reactivity units (PRU). The cutoff >208 PRU will be used
for definition of high platelet reactivity (HPR). All platelet reactivity assessments
will be performed by a physician blind to the actual treatment given. Additional blood
samples will be collected at the same time points for pharmacokinetic analysis. These
samples will be collected in vacuum tubes with lithium heparin and will be kept in ice
until centrifugation (3000 rpm at 4°C for 10 min, within 30 min of sampling). The
resultant plasma will be transferred into a plain polypropylene tube (screw cap) and
stored at or below -20°C until analysed.
Preparation of Ticagrelor liquid formulation:
Crushed and dispersed Ticagrelor 180mg for oral administration will be prepared as follows:
two ticagrelor 90mg tablets are placed in a mortar and crushed for 60 s using a pestle. 20
mL of purified water will be added in the mortar and stirred for 60s. The liquid is
transferred to a dosing cup and another 15 mL of purified water is added to the mortar and
stirred, ensuring that all powder has been dispersed and none remained on the mortar and
pestle. Again the liquid is transferred to the dosing cup. The same procedure is repeated
with 15 ml of purified water.The total contents are stirred for another 30 s to ensure that
all remaining tablet particles are dispersed.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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