Overcoming High On-Treatment Platelet Reactivity (HPR) During Prasugrel Therapy With Ticagrelor

Status unconfirmed · Phase 4

Conditions studied: Coronary Artery Disease

In brief

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-on prasugrel platelet reactivity defined as Vasodilator Stimulated Phosphoprotein-Phosphorylation (VASP-P) \>50%.

Key facts

Study ID

NCT01869309

Run by

LifeBridge Health

People needed

400

Starts

2014-01-01

Expected to finish

2016-12-01

Last updated by the study team

2014-11-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sinai Center for Thrombosis Research — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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