In Vitro Pharmacodynamic Effects of Cangrelor in Ticagrelor Treated Patients

NCT02081443 | Completed Results DMC

• 1 other identifier: CIT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Cangrelor is a potent intravenous P2Y12 receptor inhibitor with rapid onset and offset of action associated with a greater reduction in ischemic events, including stent thrombosis, in patients undergoing stent procedures who have not been pretreated with clopidogrel. In vitro investigations have shown cangrelor to be associated with more rapid, potent, and consistent platelet inhibition in patients on maintenance prasugrel therapy exposed to a re-loading dose of prasugrel. However, if cangrelor exerts similar effects in ticagrelor treated patients remain unknown. The aim of the present study is to evaluate the effects on platelet function achieved after in vitro incubation with cangrelor in patients on ticagrelor maintenance dose who receive a loading dose of ticagrelor.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; platelet function; ticagrelor; cangrelor

Outcome Measures

Primary Outcomes (1)

• Platelet Reactivity Index (PRI) Determined by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP)

  PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment

  Baseline

Secondary Outcomes (2)

• PRI Measured by VASP

  1 hour

• PRI Measured by VASP

  4 hours

Study Arms (2)

Ticagrelor 180mg

EXPERIMENTAL

The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.

Drug: Ticagrelor 90mg

Ticagrelor 90mg

ACTIVE COMPARATOR

The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.

Drug: Ticagrelor 180mg

Interventions

Ticagrelor 180mg DRUG

The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.

Also known as: Brilinta

Ticagrelor 90mg

Ticagrelor 90mg DRUG

The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.

Also known as: Brilinta

Ticagrelor 180mg

Eligibility Criteria

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

You may qualify if:

• Patients with angiographically documented coronary artery disease.
• Age between 18 to 80 years
• On treatment per standard of care with ticagrelor 90mg/b.i.d. and aspirin \<100mg/day for at least 14 days.

You may not qualify if:

• History of intracranial bleeding
• Known severe hepatic dysfunction
• Known hypersensitivy
• Active bleeding or propensity to bleed
• Platelet count \<80x106/mL
• Hemodynamic instability
• Serum creatinine \<30 mL/min
• Use of oral anticoagulants (Vitamin K antagonist, dabigatran, rivaroxaban, apixaban)
• Recent (\<14 days) antiplatelet treatment with a glycoprotein IIb/IIIa inhibitor
• Blood dyscrasia
• Patients with sick sinus syndrome (SSS) or II or III degree AV block without pacemaker
• Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromizycin
• Hemoglobin \< 10g/dL
• Pregnant females \[women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study\].

Sponsors & Collaborators

• University of Florida: lead
• The Medicines Company: collaborator

Study Sites (1)

Dominick Angiolillo

Jacksonville, Florida, 32209, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dominick J. Angiolillo, MD, PhD
• Organization: University of Florida College of Medicine-Jacksonville

dominick.angiolillo@jax.ufl.edu

+1-904-244-3933

Study Officials

• Dominick Angiolillo

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 7, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 4, 2017
• Results First Posted: March 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)