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

NCT02612116 | Completed Phase 4

• 1 other identifier: CMUMK202D
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Unstable Angina Pectoris

Outcome Measures

Primary Outcomes (1)

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

  6 hours

Secondary Outcomes (4)

• Maximum ticagrelor and AR-C124900XX concentration

  6 hours

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

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

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

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

• Platelet reactivity assessed by Multiple Electrode Aggregometry

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

Study Arms (3)

pulverized ticagrelor sublingually

ACTIVE COMPARATOR

Pulverized ticagrelor 180 mg (Brilique) administered sublingually

Drug: Pulverized ticagrelor sublingually

pulverized ticagrelor orally

ACTIVE COMPARATOR

Pulverized ticagrelor 180 mg (Brilique) administered orally

Drug: Pulverized ticagrelor orally

Integral ticagrelor orally

ACTIVE COMPARATOR

Ticagrelor 180 mg (Brilique) administered orally in integral tablets

Drug: Integral ticagrelor

Interventions

Pulverized ticagrelor sublingually DRUG

Pulverized ticagrelor (180 mg) administered sublingually

Also known as: Brilique

pulverized ticagrelor sublingually

Pulverized ticagrelor orally DRUG

Pulverized ticagrelor (180 mg) administered orally

Also known as: Brilique

pulverized ticagrelor orally

Integral ticagrelor DRUG

Integral ticagrelor (180 mg) administered orally

Also known as: Brilique

Integral ticagrelor orally

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Collegium Medicum w Bydgoszczy: lead

Study Sites (1)

Cardiology Department, Dr. A. Jurasz University Hospital

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094, Poland

Location

MeSH Terms

Conditions

Angina, Unstable

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Jacek Kubica, MD., PhD.

  Cardiology Department, Dr. A. Jurasz University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Jacek Kubica, MD, PhD

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 23, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

PL (1)