Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease

NCT01852175 | Completed Results DMC

• 1 other identifier: UFJ 2011-143
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, two P2Y12 receptor inhibitors have been approved for clinical use: prasugrel and ticagrelor. Both prasugrel and ticagrelor have shown to be associated with more potent antiplatelet effects compared with clopidogrel and are associated with an improved net clinical benefit. However, to date there are limited head-to-head comparisons of these two new agents.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Dual antiplatelet therapy; prasugrel; ticagrelor

Outcome Measures

Primary Outcomes (1)

• Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP)

  The primary end-point of the study was the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) at 1 week between prasugrel and ticagrelor.

  1 week

Secondary Outcomes (2)

• Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)

  2 hours

• Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)

  24 hours

Study Arms (2)

Prasugrel

ACTIVE COMPARATOR

Prasugrel 60mg loading dose and 10 mg maintenance dose

Drug: Prasugrel

Ticagrelor

ACTIVE COMPARATOR

Ticagrelor 180mg loading dose and 90mg bid maintenance dose

Drug: Ticagrelor

Interventions

Prasugrel DRUG

Prasugrel 60mg loading dose and 10mg maintenance dose

Also known as: Effient

Prasugrel

Ticagrelor DRUG

Ticagrelor 180mg loading dose and 90mg bid maintenance dose

Also known as: Brillinta

Ticagrelor

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with known coronary artery disease
• On maintenance treatment with aspirin (81 mg per day) and clopidogrel (75 mg per day) for at least 1-month as per standard of care.
• Age between 18 and 74 years old.

You may not qualify if:

• History of stroke, transient ischemic attack or intracranial bleeding.
• Known allergies to aspirin, prasugrel, ticagrelor, or clopidogrel.
• Weight \<60kg
• On treatment with oral anticoagulation (coumarin derivate, dabigatran).
• Hemoglobin\<10 gm/dL
• Platelet count \<80x106/mL
• Active bleeding or hemodynamic instability.
• Creatinine Clearance \<30 mL/minute.
• Baseline ALT \>2.5 times the upper limit of normal.
• Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection.
• Drugs interfering with 2C19 metabolism (to avoid interaction with clopidogrel): , fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFEND), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Serafem, Symbyax), fluvoxamine (Luvox), and ticlopidine (Ticlid).
• Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin.
• 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

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

Related Publications (2)

• Galli M, Rollini F, Been L, Zenni MM, Angiolillo DJ, Franchi F. Impact of diabetes mellitus on the pharmacodynamic effects of prasugrel and ticagrelor after switching from clopidogrel in patients with coronary artery disease. J Thromb Thrombolysis. 2022 Oct;54(3):461-469. doi: 10.1007/s11239-022-02696-4. Epub 2022 Sep 1.

  PMID: 36048358 DERIVED

• Rollini F, Franchi F, Cho JR, DeGroat C, Bhatti M, Muniz-Lozano A, Singh K, Ferrante E, Wilson RE, Dunn EC, Zenni MM, Guzman LA, Bass TA, Angiolillo DJ. A head-to-head pharmacodynamic comparison of prasugrel vs. ticagrelor after switching from clopidogrel in patients with coronary artery disease: results of a prospective randomized study. Eur Heart J. 2016 Sep 14;37(35):2722-30. doi: 10.1093/eurheartj/ehv744. Epub 2016 Feb 3.

  PMID: 26848148 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Prasugrel Hydrochloride; Ticagrelor

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 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 Angiolillo, MD, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 13, 2013
• Study Start: January 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 10, 2015
• Results First Posted: June 10, 2015

Record last verified: 2014-08

Locations

US (1)