- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01731041
Impact of Ticagrelor Re-load on Pharmacodynamic Profiles
Impact of Ticagrelor Re-load on Pharmacodynamic Profiles in Patients on Maintenance Ticagrelor Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Jacksonville, Florida, United States, 32209
- University of Florida
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
6. 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].
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ticagrelor 180mg
Patients randomized to this arm will be administered 180 mg of ticagrelor (experimental arm, loading dose).
|
Patients will receive 180 mg of ticagrelor
Other Names:
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ACTIVE_COMPARATOR: Ticagrelor 90mg
Patients randomized to this arm will be administered 90 mg dose of ticagrelor (active comparator, standard dose).
|
Patients will receive 90 mg of ticagrelor
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Platelet Reactivity Index (PRI) by Vasodilator-stimulated Phosphoprotein (VASP)
Time Frame: 4 hours
|
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
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4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
P2Y12 Reaction Units (PRU) Determined by VerifyNow P2Y12
Time Frame: 4 hours
|
Secondary analysis included the differences of platelet reactivity expressed as P2Y12 reaction units (PRU) in each group using the VerifyNow P2Y12 system.
|
4 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Ticagrelor
Other Study ID Numbers
- UFJ 2012-096
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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