Status:
UNKNOWN
Overcoming High On-Treatment Platelet Reactivity (HPR) During Prasugrel Therapy With Ticagrelor
Lead Sponsor:
LifeBridge Health
Collaborating Sponsors:
AstraZeneca
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The primary objective is to determine the pharmacodynamic effect of ticagrelor dosing (180mg LD/ 90mg BID) at 2, 4 hours and 14 days in stable Coronary artery disease (CAD) patients who exhibit high-o...
Eligibility Criteria
Inclusion
- Male or female; age ≥ 18 and \< 75 years
- Weight ≥ 60 kg
- Currently on ASA therapy and eligible to reduce ASA dose to 81 mg daily if on higher dosing
- On stable prasugrel maintenance dose for ≥1 month
- Stable CAD patients defined as: subjects with documented evidence of a history of atherosclerotic coronary artery disease/surgical revascularization (defined as either a prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft surgery). A minimum of 1 month must have elapsed between a subject's enrolment and any acute event, revascularization procedure or hospitalization for chest pain for that subject.
- If female, may be enrolled if one of the following 3 criteria are met: 1)Had a hysterectomy or tubal ligation at least 6 months prior to signing ICF, 2)Post-menopausal for at least 1 year, 3)If of childbearing potential, will practice 1 of the following methods of birth control throughout the study: oral, injectable, or implantable hormonal contraceptives; intrauterine device; diaphragm plus spermicide; or female condom plus spermicide. Methods of contraception that are not acceptable are partner's use of condoms or partner's vasectomy.
- Able and willing to provide written informed consent before entering the study
Exclusion
- Subject plans to undergo coronary revascularization at any time during the trial
- Presence or history of any of the following: ischemic or hemorrhagic stroke; transient ischemic attack (TIA); intracranial neoplasm; arteriovenous malformation, or aneurysm; intracranial hemorrhage; head trauma (within 3 months of study entry)
- History of refractory ventricular arrhythmias with an increased risk of bradycardic events (eg, subjects without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree atrioventricular (AV) block or bradycardic-related syncope)
- History or evidence of congestive heart failure (New York Heart Association Class III or above ≤ 6 months before screening
- Severe hepatic impairment defined as ALT\> 2.5 X ULN
- Uncontrolled hypertension, or systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg at screening
- Severely impaired renal function (glomerular filtration rate \< 30 mL/minute) or on dialysis
- Concomitant use with parenteral or oral anticoagulants
- Platelet count \<100 X103
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01869309
Start Date
January 1 2014
End Date
December 1 2016
Last Update
November 21 2014
Active Locations (1)
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1
Sinai Center for Thrombosis Research
Baltimore, Maryland, United States, 21215