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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Collegium Medicum w Bydgoszczy
• Treatments: Ticagrelor

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