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Comparison of Administration Strategies of Ticagrelor in Patients With Unstable Angina Pectoris, a Pharmacokinetic / Pharmacodynamic Study

Primary Purpose

Unstable Angina Pectoris

Status

Completed

Phase

Phase 4

Locations

Poland

Study Type

Interventional

Intervention

Pulverized ticagrelor sublingually

Pulverized ticagrelor orally

Integral ticagrelor

About this trial

This is an interventional treatment trial for Unstable Angina Pectoris

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Diagnosis of unstable angina
Male or non-pregnant female, aged 18-80 years old
Provision of informed consent for angiography and percutaneous coronary intervention (PCI)
GRACE score <140 pts

Exclusion Criteria:

treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
hypersensitivity to ticagrelor
current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
active bleeding
history of intracranial hemorrhage
recent gastrointestinal bleeding (within 30 days)
history of coagulation disorders
platelet count less than <100 x10^3/mcl
hemoglobin concentration less than 10.0 g/dl
history of moderate or severe hepatic impairment
history of major surgery or severe trauma (within 3 months)
patients considered by the investigator to be at risk of bradycardic events
second or third degree atrioventricular block during screening for eligibility
history of asthma or severe chronic obstructive pulmonary disease
patient requiring dialysis
manifest infection or inflammatory state
Killip class III or IV during screening for eligibility
respiratory failure
history of severe chronic heart failure (NYHA class III or IV)
concomitant therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir) or strong CYP3A inducers (rifampicin, phenytoin, carbamazepine, dexamethasone, phenobarbital) within 14 days and during study treatment
body weight below 50 kg

Sites / Locations

Cardiology Department, Dr. A. Jurasz University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

pulverized ticagrelor sublingually

pulverized ticagrelor orally

Integral ticagrelor orally

Arm Description

Pulverized ticagrelor 180 mg (Brilique) administered sublingually

Pulverized ticagrelor 180 mg (Brilique) administered orally

Ticagrelor 180 mg (Brilique) administered orally in integral tablets

Outcomes

Primary Outcome Measures

Time to maximum concentration (tmax) for ticagrelor and AR-C124900XX

Secondary Outcome Measures

Maximum ticagrelor and AR-C124900XX concentration

Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h)

Area under the plasma concentration-time curve for AR-C124900XX (AUC 0-6h)

Platelet reactivity assessed by Multiple Electrode Aggregometry

Full Information

NCT ID

NCT02612116

First Posted

November 19, 2015

Last Updated

October 18, 2016

Sponsor

Collegium Medicum w Bydgoszczy

1. Study Identification

Unique Protocol Identification Number

NCT02612116

Brief Title

Comparison of Administration Strategies of Ticagrelor in Patients With Unstable Angina Pectoris, a Pharmacokinetic / Pharmacodynamic Study

Official Title

The Impact of Administration Strategy of Ticagrelor on Its Pharmacokinetics and Pharmacodynamics in Patients With Unstable Angina Pectoris - a Randomized, Single-center, Open-label Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Collegium Medicum w Bydgoszczy

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the differences in pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite depending on the strategy of the drug administration in patients with unstable angina pectoris.

Detailed Description

On the basis of the current guidelines ticagrelor is a recommended antiplatelet agent in acute coronary syndromes, including unstable angina pectoris. According to the results of the MOJITO study, performed in patients with ST-elevation myocardial infarction, the effect of ticagrelor, measured as platelet inhibition, may be achieved sooner when crushed tablets are administered. Thus, there may be significant differences in pharmacokinetics and pharmacodynamics of ticagrelor if pulverized drug is given orally or sublingually when compared with currently used oral administration of integral tablets. The study is designed as an open-label, single-center, randomized trial of different strategies of administration of ticagrelor in patients with unstable angina pectoris. After enrollment, the participants will be randomized into three arms, each receiving ticagrelor. The drug will be given in: (1) pulverized tablets administered sublingually, (2) pulverized tablets administered orally or in (3) integral tablets orally. The time required for ticagrelor and its active metabolite AR-C124900XX to reach their maximum serum concentration will be measured as the primary outcome of the study. Moreover, further evaluation of other parameters including maximum plasma concentration and area under the plasma concentration of ticagrelor and its active metabolite will be assessed as secondary outcomes. The platelet reactivity will be measured with the Multiplate Analyzer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unstable Angina Pectoris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pulverized ticagrelor sublingually

Arm Type

Active Comparator

Arm Description

Pulverized ticagrelor 180 mg (Brilique) administered sublingually

Arm Title

pulverized ticagrelor orally

Arm Type

Active Comparator

Arm Description

Pulverized ticagrelor 180 mg (Brilique) administered orally

Arm Title

Integral ticagrelor orally

Arm Type

Active Comparator

Arm Description

Ticagrelor 180 mg (Brilique) administered orally in integral tablets

Intervention Type

Drug

Intervention Name(s)

Pulverized ticagrelor sublingually

Other Intervention Name(s)

Brilique

Intervention Description

Pulverized ticagrelor (180 mg) administered sublingually

Intervention Type

Drug

Intervention Name(s)

Pulverized ticagrelor orally

Other Intervention Name(s)

Brilique

Intervention Description

Pulverized ticagrelor (180 mg) administered orally

Intervention Type

Drug

Intervention Name(s)

Integral ticagrelor

Other Intervention Name(s)

Brilique

Intervention Description

Integral ticagrelor (180 mg) administered orally

Primary Outcome Measure Information:

Title

Time to maximum concentration (tmax) for ticagrelor and AR-C124900XX

Time Frame

6 hours

Secondary Outcome Measure Information:

Title

Maximum ticagrelor and AR-C124900XX concentration

Time Frame

6 hours

Title

Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h)

Time Frame

prior to the initial dose and 15 min, 30 min, 45 min, 1, 2, 3, 4, 6 hours post dose

Title

Area under the plasma concentration-time curve for AR-C124900XX (AUC 0-6h)

Time Frame

prior to the initial dose and 15 min, 30 min, 45 min, 1, 2, 3, 4, 6 hours post dose

Title

Platelet reactivity assessed by Multiple Electrode Aggregometry

Time Frame

prior to the initial dose and 30min, 1, 2, 3, 4, 6 hours post dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of informed consent prior to any study specific procedures Diagnosis of unstable angina Male or non-pregnant female, aged 18-80 years old Provision of informed consent for angiography and percutaneous coronary intervention (PCI) GRACE score <140 pts Exclusion Criteria: treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment hypersensitivity to ticagrelor current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin active bleeding history of intracranial hemorrhage recent gastrointestinal bleeding (within 30 days) history of coagulation disorders platelet count less than <100 x10^3/mcl hemoglobin concentration less than 10.0 g/dl history of moderate or severe hepatic impairment history of major surgery or severe trauma (within 3 months) patients considered by the investigator to be at risk of bradycardic events second or third degree atrioventricular block during screening for eligibility history of asthma or severe chronic obstructive pulmonary disease patient requiring dialysis manifest infection or inflammatory state Killip class III or IV during screening for eligibility respiratory failure history of severe chronic heart failure (NYHA class III or IV) concomitant therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir) or strong CYP3A inducers (rifampicin, phenytoin, carbamazepine, dexamethasone, phenobarbital) within 14 days and during study treatment body weight below 50 kg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacek Kubica, MD., PhD.

Organizational Affiliation

Cardiology Department, Dr. A. Jurasz University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cardiology Department, Dr. A. Jurasz University Hospital

City

Bydgoszcz

State/Province

Kujawsko-Pomorskie

ZIP/Postal Code

85-094

Country

Poland

12. IPD Sharing Statement

Learn more about this trial

Comparison of Administration Strategies of Ticagrelor in Patients With Unstable Angina Pectoris, a Pharmacokinetic / Pharmacodynamic Study

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