Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease
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ClinicalTrials.gov Identifier: NCT01852175 |
Recruitment Status
:
Completed
First Posted
: May 13, 2013
Results First Posted
: June 10, 2015
Last Update Posted
: June 10, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease | Drug: Prasugrel Drug: Ticagrelor | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 110 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A head-to Head Comparison of the Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | July 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Prasugrel
Prasugrel 60mg loading dose and 10 mg maintenance dose
|
Drug: Prasugrel
Prasugrel 60mg loading dose and 10mg maintenance dose
Other Name: Effient
|
Active Comparator: Ticagrelor
Ticagrelor 180mg loading dose and 90mg bid maintenance dose
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Drug: Ticagrelor
Ticagrelor 180mg loading dose and 90mg bid maintenance dose
Other Name: Brillinta
|
- Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP) [ Time Frame: 1 week ]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.
- Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP) [ Time Frame: 2 hours ]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) [ Time Frame: 24 hours ]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.

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Ages Eligible for Study: | 18 Years to 74 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852175
United States, Florida | |
University of Florida | |
Jacksonville, Florida, United States, 32209 |
Principal Investigator: | Dominick Angiolillo, MD, PhD | University of Florida |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT01852175 History of Changes |
Other Study ID Numbers: |
UFJ 2011-143 |
First Posted: | May 13, 2013 Key Record Dates |
Results First Posted: | June 10, 2015 |
Last Update Posted: | June 10, 2015 |
Last Verified: | August 2014 |
Keywords provided by University of Florida:
Coronary artery disease Dual antiplatelet therapy prasugrel ticagrelor |
Additional relevant MeSH terms:
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Ticagrelor |
Prasugrel Hydrochloride Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Platelet Aggregation Inhibitors |