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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Prasugrel

Ticagrelor

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Dual antiplatelet therapy, prasugrel, ticagrelor

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Prasugrel

Ticagrelor

Arm Description

Prasugrel 60mg loading dose and 10 mg maintenance dose

Ticagrelor 180mg loading dose and 90mg bid maintenance dose

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)

A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 2 hours after loading dose.

Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)

A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 24 hours after loading dose.

Full Information

NCT ID

NCT01852175

First Posted

May 8, 2013

Last Updated

May 26, 2015

Sponsor

University of Florida

1. Study Identification

Unique Protocol Identification Number

NCT01852175

Brief Title

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

Official Title

A head-to Head Comparison of the Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Dual antiplatelet therapy consisting of aspirin and clopidogrel is the cornerstone of treatment for prevention of thrombotic events in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, there are a considerable number of patients who continue to have recurrent ischemic events despite this treatment regimen. These observations underscore the need for more potent antiplatelet therapies. 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. These more favorable pharmacodynamic effects translate into reduced ischemic event rates, at the expense of an increased risk of bleeding in patients with acute coronary syndromes. Overall, these drugs are associated with an improved net clinical benefit. These findings from large-scale clinical investigations have led to approval of prasugrel and ticagrelor. However, to date there are limited head-to-head comparisons of these two new agents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Coronary artery disease, Dual antiplatelet therapy, prasugrel, ticagrelor

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prasugrel

Arm Type

Active Comparator

Arm Description

Prasugrel 60mg loading dose and 10 mg maintenance dose

Arm Title

Ticagrelor

Arm Type

Active Comparator

Arm Description

Ticagrelor 180mg loading dose and 90mg bid maintenance dose

Intervention Type

Drug

Intervention Name(s)

Prasugrel

Other Intervention Name(s)

Effient

Intervention Description

Prasugrel 60mg loading dose and 10mg maintenance dose

Intervention Type

Drug

Intervention Name(s)

Ticagrelor

Other Intervention Name(s)

Brillinta

Intervention Description

Ticagrelor 180mg loading dose and 90mg bid maintenance dose

Primary Outcome Measure Information:

Title

Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP)

Description

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.

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)

Description

A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 2 hours after loading dose.

Time Frame

2 hours

Title

Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)

Description

A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 24 hours after loading dose.

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dominick Angiolillo, MD, PhD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

36048358

Citation

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.

Results Reference

derived

PubMed Identifier

26848148

Citation

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.

Results Reference

derived

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

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