Viewing Study NCT02046486



Ignite Creation Date: 2024-05-06 @ 2:27 AM
Last Modification Date: 2024-10-26 @ 11:18 AM
Study NCT ID: NCT02046486
Status: COMPLETED
Last Update Posted: 2015-01-27
First Post: 2014-01-23

Brief Title: OraL Crushed and dIspersed Ticagrelor 180mg Compared to Whole Tablets of eQUal Dose in STEMI Patients unDergoing Primary PCI a PharmacokineticPharmacodynamic Study the LIQUID Study
Sponsor: University of Patras
Organization: University of Patras

Study Overview

Official Title: OraL Crushed and dIspersed Ticagrelor 180mg Compared to Whole Tablets of eQUal Dose in STEMI Patients unDergoing Primary PCI a PharmacokineticPharmacodynamic Study
Status: COMPLETED
Status Verified Date: 2015-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: LIQUID
Brief Summary: This is a single-center prospective randomized single-blind investigator initiated pharmacokineticpharmacodynamic study of parallel designPatients with ST elevation myocardial infarction symptom onset12 hours undergoing primary percutaneous coronary intervention who are P2Y12 inhibitor naïve will be randomized after informed consent immediately after diagnostic coronary angiography in a 11 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 05 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 4C 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 -20C until analysed
Detailed Description: 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 waterThe total contents are stirred for another 30 s to ensure that all remaining tablet particles are dispersed

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None