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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
Sponsored by
Collegium Medicum w Bydgoszczy
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Active Comparator

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

First Posted
November 19, 2015
Last Updated
October 18, 2016
Sponsor
Collegium Medicum w Bydgoszczy
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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
No

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
No
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

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

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