Platelet Reactivity With Clopidogrel Versus Prasugrel in Patients With Systolic Heart Failure

0574-11-FB

The investigators aim to determine if patients with systolic heart failure treated with prasugrel achieve greater platelet inhibition compared to those treated with clopidogrel.

2013-05-15

2015-12-01

2015-12-28

Completed

Early phase I

30

Inclusion Criteria: * Patients 19 to 74 years of age. * Patients with a left ventricular ejection fraction \<35% by echocardiogram, SPECT myocardial perfusion study, cardiac MRI, cardiac computerized tomographic angiogram or invasive left ventricular angiogram within the last 6 months. * Patients with NYHA Class III-IV heart failure at the time of enrollment. Exclusion Criteria: * Recent hospitalization within 30 days * Patients expected to undergo major surgery or PCI in the next 30 days * Patients taking clopidogrel, prasugrel, ticagrelor, ticlopidine, or cilostazol * Patients listed for heart transplantation or having left ventricular assist device placement * Patients with known allergy to either medication * Patients with prior history of stroke or transient ischemic attack * Patients with known intracranial neoplasm, aneurysm, or arteriovenous malformation * Patients with a history of bleeding requiring hospitalization for treatment * Patients taking oral anticoagulants * Patients with body weight \<60 kg * Women who are pregnant or breastfeeding * Patients with hemoglobin \<10 mg/dl or platelet count \<100,000/ul at baseline * Patients with known clotting or platelet disorders * Patients with a baseline INR \> 1.4 * Patients with liver function tests (AST or ALT) \> 2 times normal * Patients with a suspected change in their use of aspirin during the study (starting, stopping, or changing dose of aspirin) * Patients unwilling to consent to CYP2C19 genetic testing.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

2023-10-10