Ticagrelor Pharmacokinetics in NSTEMI

NCT02292277 | Completed

• 1 other identifier: 2014/1174-31/1
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with myocardial infarction, which does not include all layers of the heart's muscle wall are common and they often receive pharmacological treatment with the platelet inhibiting drug ticagrelor. However, the drug uptake after an oral dose of 180mg ticagrelor has not been thoroughly studied in these patients. The present study will evaluate ticagrelor uptake and platelet aggregation after a 180 mg loading dose ticagrelor in these patients.

Conditions

Myocardial Infarction

Keywords

Ticagrelor; Pharmacokinetics; Platelet Aggregation; Platelet Function Tests

Outcome Measures

Primary Outcomes (1)

• Tmax ticagrelor

  Time to maximum concentration (Tmax) of ticagrelor after a 180 mg loading dose.

  Within 6 hours after oral intake

Secondary Outcomes (3)

• Tmax AR-C124910XX

  Within 6 hours after oral intake

• Pharmacodynamic response

  Predose, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post dose.

• HPR at 2 hours

  2 hours after oral intake

Study Arms (2)

NSTEMI patients

Subjects eligible for the study will be ticagrelor naïve patients with NSTEMI presenting at the emergency room. Upon arrival to the emergency room written informed consent will be obtained before the patients receive their 180 mg loading dose of ticagrelor, as prescribed by the responsible physician.

Drug: Ticagrelor

SCAD controls

Patients with stable coronary artery disease (SCAD) planned for elective angiography. If PCI is to be performed and if the responsible physician decides to administrate a loading dose of 180 mg ticagrelor, written informed consent will be obtained before loading dose and blood sampling.

Drug: Ticagrelor

Interventions

Ticagrelor DRUG

Oral loading dose of 180 mg ticagrelor.

Also known as: Brilique

NSTEMI patients; SCAD controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting at emergency department and angiography laboratory

You may qualify if:

• A diagnosis of NSTEMI (i.e relevant symptoms associated with ischemic ECG changes (not categorized as STEMI) and/or relevantly increased cardiac markers);
• An indication for a 180 mg ticagrelor loading dose.

You may not qualify if:

• Ticagrelor contraindication, including
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Active pathological bleeding
• History of intracranial haemorrhage
• Moderate to severe hepatic impairment.
• Co-administration of ticagrelor with strong CYP3A4 inhibitors (e.g., ketoconazole,clarithromycin, nefazodone, ritonavir, and atazanavir) is contraindicated, as co-administration may lead to a substantial increase in exposure to ticagrelor
• Age \<18 years

Sponsors & Collaborators

• Karolinska University Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Södersjukhuset

Stockholm, 118 83, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples of venous blood will be collected into lithium-heparin tubes, centrifuged at 1500 g at 4ºC for 10 min within 30 min of blood sampling at the following time points: pre-dose, 1, 2, 3, 4, 5, and 6 hours post-dose, as shown in the table below. For P2Y12-antagonist naïve patients and controls, sampling of venous blood into Hirudin tubes for pharmacodynamics evaluation will be performed for analysis using an ADP-induced platelet aggregation assay. The resulting plasma samples will then be stored below minus 20ºC until analyzed. Plasma concentrations of ticagrelor and its active metabolite AR-C124910XX will be determined by validated methods (high-performance liquid chromatography and tandem mass spectrometry detection; LC-MS/MS) at a certified laboratory.

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

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

• Jan van der Linden, MD, PhD

  Dept of Molecular Medicine and Surgery, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 17, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: January 1, 2016
• Last Updated: May 23, 2016

Record last verified: 2016-05

Locations

SE (1)