ST Elevation Myocardial Infarction Clinical Trial
— LIQUIDOfficial title:
OraL Crushed and dIspersed Ticagrelor 180mg Compared to Whole Tablets of eQUal Dose in STEMI Patients unDergoing Primary PCI: a Pharmacokinetic/Pharmacodynamic Study
Verified date | January 2015 |
Source | University of Patras |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age =18 years old 2. Patients with STEMI (onset of pain<12 hours) with indication for primary PCI 3. Informed consent obtained in writing Exclusion Criteria: Pregnancy/Breastfeeding - Severe nausea or vomiting - Treatment with a P2Y12 inhibitor within the previous 1 month - Inability to give informed consent - Hemodynamic instability - Arrhythmias requiring cardioversion, temporary pacemaker insertion or intravenous antiarrhythmic agents - Killip class =3 - Known hypersensitivity to ticagrelor - History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months. - Other bleeding diathesis, or considered by investigator to be at high risk for bleeding - Thombocytopenia (<100.000 / µL) at randomization - Anaemia (Hct <30%) at randomization - Polycytaemia (Hct > 52%) at randomization - Periprocedural IIb/IIIa inhibitor administration - Thrombolysis administration - Recent (< 6 weeks) major surgery or trauma, including GABG. - Concomitant oral or IV therapy with strong CY P3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazana vir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3A inducers (rifampin /rifampicin, phenytoin, carbamazepine). - Patients considered by the investigator to be at increased risk of bradycardiac events. - Dialysis required. - Severe uncontrolled chronic obstructive pulmonary disease - Known severe hepatic impairement |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | Patras University Hospital Department of Cardiology | Patras | Achaia |
Lead Sponsor | Collaborator |
---|---|
University of Patras |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ticagrelor's Cmax over 1 hour post ticagrelor administration | 1 hour | No | |
Primary | Area under the ticagrelor plasma concentration versus time curve (AUC0-1) over 1 hour post ticagrelor administration | 1 hour | No | |
Secondary | Platelet reactivity at 1 hour post randomization | Platelet reactivity assessment with the VerifyNow assay | 1 hour | No |
Secondary | HPR rate at 1 hour post randomization | HPR rate at 1 hour post randomization between the two treatment arms | 1 hour | No |
Secondary | Platelet reactivity at 2 hours post randomization | Platelet reactivity assessment with the VerifyNow assay | 2 hours | No |
Secondary | HPR rate at 2 hours post randomization | HPR rate at 2 hours post randomization between the 2 treatment arms. | 2 hours | No |
Secondary | AR-C124910XX Cmax over 1 hour post ticagrelor administration | 1 hour | No | |
Secondary | AR-C124910XX Cmax over 6 hours post ticagrelor administration | 6 hours | No | |
Secondary | Ticagrelor Cmax over 6 hours post ticagrelor administration | 6 hours | No | |
Secondary | Area under the AR-C124910XX plasma concentration versus time curve (AUC0-1) over 1 hour post ticagrelor administration | 1 hour | No | |
Secondary | Area under the AR-C124910XX plasma concentration versus time curve (AUC0-6) over 6 hours post ticagrelor administration | 6 hours | No | |
Secondary | Area under the Ticagrelor plasma concentration versus time curve (AUC0-6) over 6 hours post ticagrelor administration | 6 hours | No | |
Secondary | Time for the maximum plasma concentration (Tmax) of Ticagrelor over 6 hours post Ticagrelor administration | 6 hours | No | |
Secondary | Time for the maximum plasma concentration (Tmax) of AR-C124910XX over 6 hours post Ticagrelor administration | 6 hours | No |
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