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

NCT ID: NCT01852175

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-07-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prasugrel

Prasugrel 60mg loading dose and 10 mg maintenance dose

Group Type: ACTIVE_COMPARATOR

Prasugrel

Intervention Type: DRUG

Prasugrel 60mg loading dose and 10mg maintenance dose

Ticagrelor

Ticagrelor 180mg loading dose and 90mg bid maintenance dose

Group Type: ACTIVE_COMPARATOR

Ticagrelor

Intervention Type: DRUG

Ticagrelor 180mg loading dose and 90mg bid maintenance dose

Interventions

Prasugrel

Prasugrel 60mg loading dose and 10mg maintenance dose

Intervention Type: DRUG

Ticagrelor

Ticagrelor 180mg loading dose and 90mg bid maintenance dose

Intervention Type: DRUG

Other Intervention Names

Effient; Brillinta

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominick Angiolillo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Jacksonville, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36048358 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26848148 (View on PubMed)

Other Identifiers

UFJ 2011-143

Identifier Type: -

Identifier Source: org_study_id