Impact of Ticagrelor Re-load on Pharmacodynamic Profiles

NCT01731041 | Completed Results DMC

• 1 other identifier: UFJ 2012-096
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Platelets are parts of your blood that stick together to help form a clot. The stickier your platelets are, the greater your chance of having a heart attack. A clot in the wrong place can lead to a heart attack or stroke. Ticagrelor (Brilinta) keeps platelets from sticking together and it helps people from having a heart attack. The American College of Cardiology has recommended a combination of aspirin and Brilinta as one of the best treatments for the prevention of heart attacks, and death in patients who have had a heart attack or coronary stents. However, it is unknown if Brilinta may improve its work to keep platelets from sticking together giving a loading dose in patients already treated with Brilinta. A loading dose is a one-time increased dose of the same drug. The purpose of this study is to demonstrate whether the platelets of patients treated with Brilinta become less sticky when Brilinta is re-loaded.

Conditions

Coronary Artery Disease

Keywords

coronary disease, platelet function, platelet inhibitors

Outcome Measures

Primary Outcomes (1)

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

  The primary end-point of the study is the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) between baseline and 4-hour after dosing in each arm of treatment

  4 hours

Secondary Outcomes (1)

• P2Y12 Reaction Units (PRU) Determined by VerifyNow P2Y12

  4 hours

Study Arms (2)

Ticagrelor 180mg

EXPERIMENTAL

Patients randomized to this arm will be administered 180 mg of ticagrelor (experimental arm, loading dose).

Drug: Ticagrelor 180mg

Ticagrelor 90mg

ACTIVE COMPARATOR

Patients randomized to this arm will be administered 90 mg dose of ticagrelor (active comparator, standard dose).

Drug: Ticagrelor 90mg

Interventions

Ticagrelor 180mg DRUG

Patients will receive 180 mg of ticagrelor

Also known as: Brilinta

Ticagrelor 180mg

Ticagrelor 90mg DRUG

Patients will receive 90 mg of ticagrelor

Also known as: Brilinta

Ticagrelor 90mg

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 a clinical indication to be on ticagrelor therapy (90mg/bid)
• On treatment with ticagrelor 90mg twice daily for at least 14 days
• Age between 18 to 80 years
• On aspirin \<100mg/day

You may not qualify if:

• History of intracranial bleeding
• Severe hepatic impairment (ALT \>2.5 times the upper limit of normal)
• Active bleeding or propensity to bleed
• Recent antiplatelet treatment (\< 14 days) with a glycoprotein IIb/IIIa antagonist
• \. Platelet count \<80x106/mL 7. Hemodynamic instability 8. Serum creatinine \<30 mL/min 9. On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban) 10. Patients with sick sinus syndrome or II or III degree AV block without pacemaker protection 12. Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromizycin 13. Hemoglobin \< 10g/dL 14. 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
• AstraZeneca: collaborator

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

Related Publications (1)

• Cho JR, Rollini F, Franchi F, DeGroat C, Bhatti M, Dunn EC, Ferrante E, Muniz-Lozano A, Suryadevara S, Zenni MM, Guzman LA, Bass TA, Angiolillo DJ. Pharmacodynamic Effects of Ticagrelor Dosing Regimens in Patients on Maintenance Ticagrelor Therapy: Results From a Prospective, Randomized, Double-Blind Investigation. JACC Cardiovasc Interv. 2015 Jul;8(8):1075-1083. doi: 10.1016/j.jcin.2015.02.022. Epub 2015 Jun 24.

  PMID: 26117466 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

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-Associate Professor of Medicine Director, Cardiovascular Research
• Organization: University of Florida College of Medicine-Jacksonville

dominick.angiolillo@jax.ufl.edu

+1-904-244-3005

Study Officials

• Dominick J Angiolillo, MD, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 21, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 10, 2015
• Results First Posted: June 10, 2015

Record last verified: 2015-05

Locations

US (1)